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INVO:Segment
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2023
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from ________________ to ________________
Commission
File Number: 001-39701
INVO
Bioscience, Inc.
(Exact
Name of Registrant as Specified in its Charter)
Nevada |
|
20-4036208 |
(State
or other jurisdiction
of
incorporation or organization) |
|
(I.R.S.
Employer
Identification
No.) |
5582 Broadcast
Court |
|
|
Sarasota,
FL |
|
34240 |
(Address of principal executive
offices) |
|
(Zip Code) |
(978)
878-9505
(Registrant’s
telephone number, including area code)
Not
applicable
(Former
name, former address and former fiscal year, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
symbol(s) |
|
Name
of each exchange on which registered |
Common Stock, $0.0001
par value per share |
|
INVO |
|
The Nasdaq Stock Market
LLC |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated
filer ☐ |
|
Accelerated
filer ☐ |
|
|
Non-accelerated filer ☒ |
|
Smaller reporting company
☒ |
|
Emerging growth company
☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of August 14, 2023, the Registrant had 2,449,662 shares of common stock outstanding.
INVO
BIOSCIENCE, INC.
FORM
10-Q
FOR
THE QUARTERLY PERIOD ENDED June 30, 2023
TABLE
OF CONTENTS
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA
This
Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A
of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934,
as amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,”
“should,” “expects,” “intends,” “plans,” “anticipates,” “believes,”
“estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other
comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections
about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually
achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially
from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements
involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding:
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our
business strategies; |
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the
timing of regulatory submissions; |
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our
ability to obtain and maintain regulatory approval of our existing product candidates and any other product candidates we may develop,
and the labeling under any approval we may obtain; |
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risks
relating to the timing and costs of clinical trials and the timing and costs of other expenses; |
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risks
related to market acceptance of products; |
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the
ultimate impact of the ongoing Coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research
programs, healthcare systems or the global economy as a whole; |
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intellectual
property risks; |
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risks
associated with our reliance on third-party organizations; |
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our
competitive position; |
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our
industry environment; |
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our
anticipated financial and operating results, including anticipated sources of revenues; |
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assumptions
regarding the size of the available market, benefits of our products, product pricing and timing of product launches; |
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management’s
expectation with respect to future acquisitions; |
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statements
regarding our goals, intentions, plans and expectations, including the introduction of new products and markets; and |
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our
cash needs and financing plans. |
All
of our forward-looking statements are as of the date of this Quarterly Report on Form 10-Q only. In each case, actual results may differ
materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will
prove to be correct. An occurrence of, or any material adverse change in, one or more of the risk factors or risks and uncertainties
referred to in this Quarterly Report on Form 10-Q or included in our other public disclosures or our other periodic reports or other
documents or filings filed with or furnished to the U.S. Securities and Exchange Commission (the “SEC”) could materially
and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we do not undertake
or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or
projections or other circumstances affecting such forward-looking statements occurring after the date of this Quarterly Report on Form
10-Q, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public
statements or disclosures by us following this Quarterly Report on Form 10-Q that modify or impact any of the forward-looking statements
contained in this Quarterly Report on Form 10-Q will be deemed to modify or supersede such statements in this Quarterly Report on Form
10-Q.
This
Quarterly Report on Form 10-Q may include market data and certain industry data and forecasts, which we may obtain from internal company
surveys, market research, consultant surveys, publicly available information, reports of governmental agencies and industry publications,
articles and surveys. Industry surveys, publications, consultant surveys and forecasts generally state that the information contained
therein has been obtained from sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed.
While we believe that such studies and publications are reliable, we have not independently verified market and industry data from third-party
sources.
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
INVO
BIOSCIENCE, INC.
CONSOLIDATED
BALANCE SHEETS
(UNAUDITED)
| |
| | |
| |
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
| | | |
| (audited) | |
ASSETS | |
| | | |
| | |
Current assets | |
| | | |
| | |
Cash | |
$ | 112,485 | | |
$ | 90,135 | |
Accounts receivable | |
| 74,908 | | |
| 77,149 | |
Inventory | |
| 280,018 | | |
| 263,602 | |
Prepaid expenses and other current assets | |
| 374,714 | | |
| 190,201 | |
Total current assets | |
| 842,125 | | |
| 621,087 | |
Property and equipment, net | |
| 659,442 | | |
| 436,729 | |
Lease right of use | |
| 4,004,962 | | |
| 1,808,034 | |
Investment in joint ventures | |
| 1,132,365 | | |
| 1,237,865 | |
Total assets | |
$ | 6,638,894 | | |
$ | 4,103,715 | |
LIABILITIES AND STOCKHOLDERS’ DEFICIT | |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable and accrued liabilities | |
$ | 1,844,629 | | |
$ | 1,349,038 | |
Accrued compensation | |
| 1,202,420 | | |
| 946,262 | |
Notes payable, net | |
| 263,888 | | |
| 100,000 | |
Notes payable – related parties, net | |
| 770,000 | | |
| 662,644 | |
Notes payable, net | |
| 770,000 | | |
| 662,644 | |
Deferred revenue | |
| 161,187 | | |
| 119,876 | |
Lease liability, current portion | |
| 227,026 | | |
| 231,604 | |
Total current liabilities | |
| 4,469,150 | | |
| 3,409,424 | |
Lease liability, net of current portion | |
| 3,873,289 | | |
| 1,669,954 | |
Deferred tax liability | |
| 1,949 | | |
| 1,949 | |
Total liabilities | |
| 8,344,388 | | |
| 5,081,327 | |
| |
| | | |
| | |
Stockholders’ deficit | |
| | | |
| | |
Common Stock, $.0001 par value; 6,250,000 shares authorized; 826,886 and 608,611 issued and outstanding as of June 30, 2023 and December 31, 2022, respectively | |
| 83 | | |
| 61 | |
Additional paid-in capital | |
| 52,869,346 | | |
| 48,805,860 | |
Accumulated deficit | |
| (54,574,923 | ) | |
| (49,783,533 | ) |
Total stockholders’ deficit | |
| (1,705,494 | ) | |
| (977,612 | ) |
Total liabilities and stockholders’ deficit | |
$ | 6,638,894 | | |
$ | 4,103,715 | |
The
accompanying notes are an integral part of these consolidated financial statements.
INVO
BIOSCIENCE, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(UNAUDITED)
| |
| | |
| | |
| | |
| |
| |
For the Three Months | | |
For the Six Months | |
| |
Ended June 30, | | |
Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Revenue: | |
| | | |
| | | |
| | | |
| | |
Clinic revenue | |
$ | 254,364 | | |
$ | 112,358 | | |
$ | 551,745 | | |
$ | 218,206 | |
Product revenue | |
| 61,538 | | |
| 33,777 | | |
| 112,182 | | |
| 90,527 | |
Total revenue | |
| 315,902 | | |
| 146,135 | | |
| 663,927 | | |
| 308,733 | |
Operating expenses | |
| | | |
| | | |
| | | |
| | |
Cost of revenue | |
| 235,714 | | |
| 170,526 | | |
| 466,719 | | |
| 367,207 | |
Selling, general and administrative expenses | |
| 2,042,609 | | |
| 2,444,586 | | |
| 4,373,443 | | |
| 4,991,714 | |
Research and development expenses | |
| 83,850 | | |
| 190,761 | | |
| 157,370 | | |
| 294,941 | |
Depreciation and amortization | |
| 19,705 | | |
| 22,083 | | |
| 38,792 | | |
| 37,630 | |
Total operating expenses | |
| 2,381,879 | | |
| 2,827,956 | | |
| 5,036,324 | | |
| 5,691,492 | |
Loss from operations | |
| (2,065,977 | ) | |
| (2,681,821 | ) | |
| (4,372,397 | ) | |
| (5,382,759 | ) |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Income (loss) from equity method joint ventures | |
| 3,788 | | |
| (117,978 | ) | |
| (23,947 | ) | |
| (189,095 | ) |
Interest income | |
| - | | |
| 48 | | |
| - | | |
| 273 | |
Interest expense | |
| (175,192 | ) | |
| (102 | ) | |
| (391,781 | ) | |
| (1,558 | ) |
Foreign currency exchange loss | |
| (265 | ) | |
| (888 | ) | |
| (400 | ) | |
| (1,914 | ) |
Total other income (expense) | |
| (171,669 | ) | |
| (118,920 | ) | |
| (416,128 | ) | |
| (192,294 | ) |
Income taxes | |
| 2,865 | | |
| 800 | | |
| 2,865 | | |
| 800 | |
Net loss | |
$ | (2,240,511 | ) | |
$ | (2,801,541 | ) | |
$ | (4,791,390 | ) | |
$ | (5,575,853 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per common share: | |
| | | |
| | | |
| | | |
| | |
Basic | |
$ | (3.06 | ) | |
$ | (4.62 | ) | |
$ | (7.07 | ) | |
$ | (9.23 | ) |
Diluted | |
$ | (3.06 | ) | |
$ | (4.62 | ) | |
$ | (7.07 | ) | |
$ | (9.23 | ) |
Weighted average number of common shares outstanding: | |
| | | |
| | | |
| | | |
| | |
Basic | |
| 732,255 | | |
| 605,760 | | |
| 677,684 | | |
| 604,123 | |
Diluted | |
| 732,255 | | |
| 605,760 | | |
| 677,684 | | |
| 604,123 | |
The
accompanying notes are an integral part of these consolidated financial statements.
INVO
BIOSCIENCE, INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
(UNAUDITED)
| |
| | |
| | |
| | |
| | |
| |
| |
Common Stock | | |
Additional Paid-in | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Total | |
| |
| | |
| | |
| | |
| | |
| |
Balances, December 31, 2021 | |
| 596,457 | | |
$ | 60 | | |
$ | 46,200,509 | | |
$ | (38,891,022 | ) | |
$ | 7,310,680 | |
Common stock issued to directors and employees | |
| 2,576 | | |
| - | | |
| 328,548 | | |
| - | | |
| 328,548 | |
Common stock issued for services | |
| 2,750 | | |
| - | | |
| 116,766 | | |
| - | | |
| 116,766 | |
Proceeds from sale of common stock, net of fees and expenses | |
| 4,731 | | |
| - | | |
| 315,000 | | |
| - | | |
| 315,000 | |
Stock options issued to directors and employees as compensation | |
| - | | |
| - | | |
| 861,284 | | |
| - | | |
| 861,284 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (5,575,853 | ) | |
| (5,575,853 | ) |
Balances, June 30, 2022 | |
| 606,514 | | |
$ | 60 | | |
$ | 47,823,860 | | |
$ | (44,466,875 | ) | |
$ | 3,356,425 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balances, December 31, 2022 | |
| 608,611 | | |
$ | 61 | | |
$ | 48,805,860 | | |
$ | (49,783,533 | ) | |
$ | (977,612 | ) |
Balances, value | |
| 608,611 | | |
$ | 61 | | |
$ | 48,805,860 | | |
$ | (49,783,533 | ) | |
$ | (977,612 | ) |
Common stock issued to directors and employees | |
| 3,994 | | |
| - | | |
| 51,565 | | |
| - | | |
| 51,565 | |
Common stock issued for services | |
| 25,817 | | |
| 3 | | |
| 244,173 | | |
| - | | |
| 244,176 | |
Proceeds from the sale of common stock, net of fees and expenses | |
| 184,000 | | |
| 18 | | |
| 2,728,920 | | |
| - | | |
| 2,728,938 | |
Common stock issued with notes payable | |
| 4,167 | | |
| 1 | | |
| 56,313 | | |
| - | | |
| 56,314 | |
Options exercised for cash | |
| 297 | | |
| - | | |
| 2,375 | | |
| - | | |
| 2,375 | |
Stock options issued to directors and employees as compensation | |
| - | | |
| - | | |
| 652,750 | | |
| - | | |
| 652,750 | |
Warrants issued with notes payable | |
| - | | |
| - | | |
| 327,390 | | |
| - | | |
| 327,390 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (4,791,390 | ) | |
| (4,791,390 | ) |
Balances, June 30, 2023 | |
| 826,886 | | |
$ | 83 | | |
$ | 52,869,346 | | |
$ | (54,574,923 | ) | |
$ | (1,705,494 | ) |
Balances, value | |
| 826,886 | | |
$ | 83 | | |
$ | 52,869,346 | | |
$ | (54,574,923 | ) | |
$ | (1,705,494 | ) |
The
accompanying notes are an integral part of these consolidated financial statements.
INVO
BIOSCIENCE, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(UNAUDITED)
| |
| | |
| |
| |
For the Six Months Ended | |
| |
June 30, | |
| |
2023 | | |
2022 | |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (4,791,390 | ) | |
$ | (5,575,853 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Non-cash stock compensation issued for services | |
| 244,176 | | |
| 116,766 | |
Non-cash stock compensation issued to directors and employees | |
| 51,565 | | |
| 328,548 | |
Fair value of stock options issued to employees | |
| 652,750 | | |
| 861,284 | |
Non-cash compensation for services | |
| 90,000 | | |
| 30,000 | |
Amortization of discount on notes payable | |
| 301,098 | | |
| - | |
Loss from equity method investment | |
| 23,947 | | |
| 189,095 | |
Depreciation and amortization | |
| 38,792 | | |
| 37,629 | |
Changes in assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| 2,241 | | |
| (6,015 | ) |
Inventory | |
| (16,416 | ) | |
| 5,777 | |
Prepaid expenses and other current assets | |
| (184,513 | ) | |
| 35,069 | |
Accounts payable and accrued expenses | |
| 432,654 | | |
| 23,553 | |
Accrued compensation | |
| 256,158 | | |
| (72,885 | ) |
Deferred revenue | |
| 41,311 | | |
| 71,457 | |
Leasehold liability | |
| 1,829 | | |
| 4,655 | |
Accrued Interest | |
| 62,938 | | |
| - | |
Net cash used in operating activities | |
| (2,792,860 | ) | |
| (3,950,920 | ) |
Cash from investing activities: | |
| | | |
| | |
Payments to acquire property, plant, and equipment | |
| (261,505 | ) | |
| (8,338 | ) |
Payments to acquire intangible assets | |
| - | | |
| (1,517 | ) |
Investment in joint ventures | |
| (8,447 | ) | |
| (76,937 | ) |
Net cash used in investing activities | |
| (269,952 | ) | |
| (86,792 | ) |
Cash from financing activities: | |
| | | |
| | |
Proceeds from the sale of notes payable | |
| 714,000 | | |
| - | |
Proceeds from the sale of common stock, net of offering costs | |
| 2,728,938 | | |
| 315,000 | |
Proceeds from option exercise | |
| 2,375 | | |
| - | |
Principal payments on note payable | |
| (360,151 | ) | |
| - | |
Net cash provided by financing activities | |
| 3,085,162 | | |
| 315,000 | |
Increase (decrease) in cash and cash equivalents | |
| 22,350 | | |
| (3,722,712 | ) |
Cash and cash equivalents at beginning of period | |
| 90,135 | | |
| 5,684,871 | |
Cash and cash equivalents at end of period | |
$ | 112,485 | | |
$ | 1,962,159 | |
| |
| | | |
| | |
Supplemental disclosure of cash flow information: | |
| | | |
| | |
Cash paid during the period for: | |
| | | |
| | |
Interest | |
$ | 5,720 | | |
$ | - | |
Taxes | |
$ | - | | |
$ | 2,847 | |
Noncash activities: | |
| | | |
| | |
Fair value of warrants issued with debt | |
$ | 327,390 | | |
$ | - | |
Initial ROU asset and lease liability | |
$ | 2,312,892 | | |
$ | - | |
The
accompanying notes are an integral part of these consolidated financial statements.
INVO
BIOSCIENCE, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
June
30, 2023
(UNAUDITED)
Note
1 – Summary of Significant Accounting Policies
Description
of Business
INVO
Bioscience, Inc. (“INVO” or the “Company”) is a healthcare services fertility company dedicated to expanding
the assisted reproductive technology (“ART”) marketplace by making fertility care accessible and inclusive to people around
the world. The Company’s commercialization strategy is focused on the opening of dedicated “INVO Centers” offering
the INVOcell and IVC procedure (with three centers in North America now operational), the acquisition of US-based, profitable in vitro
fertilization (“IVF”) clinics and the sale and distribution of our technology solution into existing fertility clinics. The
Company’s proprietary technology, INVOcell, is a revolutionary medical device that allows fertilization and early embryo development
to take place in vivo within the woman’s body. This treatment solution is the world’s first intravaginal culture technique
for the incubation of oocytes and sperm during fertilization and early embryo development.
Basis
of Presentation
The
accompanying consolidated financial statements present on a consolidated basis the accounts of the Company and its wholly owned subsidiaries
and controlled affiliates. The Company presents noncontrolling interest within the equity section of its consolidated balance sheets
and the amount of consolidated net income (loss) that is attributable to the Company and to the noncontrolling interest in its consolidated
statement of operations. All significant intercompany accounts and transactions have been eliminated in consolidation.
The
Company uses the equity method of accounting when it owns an interest in an entity whereby it can exert significant influence over but
cannot control the entity’s operations.
The
preparation of the Company’s consolidated financial statements requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated
financial statements and the reported amounts of revenues and expenses during the reporting periods.
The
Company considers events or transactions that have occurred after the consolidated balance sheet date of June 30, 2023, but prior to
the filing of the consolidated financial statements with the SEC in this Quarterly Report on Form 10-Q, to provide additional evidence
relative to certain estimates or to identify matters that require additional disclosure, as applicable. Subsequent events have been evaluated
through the date of the filing of this Quarterly Report on Form 10-Q.
Reclassifications
Certain amounts in the consolidated financial statements for the prior
year have been reclassified to conform to the current year presentation. These reclassifications had no impact on net earnings, financial
position, or cash flows.
Business
Segments
The
Company operates in one segment and therefore segment information is not presented.
Variable
Interest Entities
The
Company’s consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries, and variable interest
entities (“VIE”), where the Company is the primary beneficiary under the provisions of ASC 810, Consolidation (“ASC
810”). A VIE must be consolidated by its primary beneficiary when, along with its affiliates and agents, the primary beneficiary
has both: (i) the power to direct the activities that most significantly impact the VIE’s economic performance; and (ii) the obligation
to absorb losses or the right to receive the benefits of the VIE that could potentially be significant to the VIE. The Company reconsiders
whether an entity is still a VIE only upon certain triggering events and continually assesses its consolidated VIEs to determine if it
continues to be the primary beneficiary. See “Note 3 – Variable Interest Entities” for additional information on the
Company’s VIEs.
Equity
Method Investments
Investments
in unconsolidated affiliates, which the Company exerts significant influence but does not control or otherwise consolidate, are accounted
for using the equity method. Equity method investments are initially recorded at cost. These investments are included in investment in
joint ventures in the accompanying consolidated balance sheets. The Company’s share of the profits and losses from these investments
is reported in loss from equity method joint venture in the accompanying consolidated statements of operations. The Company monitors
its investments for other-than-temporary impairment by considering factors such as current economic and market conditions and the operating
performance of the investees and records reductions in carrying values when necessary.
Use
of Estimates
In
preparing financial statements in conformity with generally accepted accounting principles, management is required to make estimates
and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at
the date of the financial statements and revenues and expenses during the reported period. Actual results could differ from those estimates.
Cash
and Cash Equivalents
For
financial statement presentation purposes, the Company considers time deposits, certificates of deposit and all highly liquid investments
with original maturities of three months or less to be cash and cash equivalents. At times, cash and cash equivalents balances exceed
amounts insured by the Federal Deposit Insurance Corporation.
Inventory
Inventories
consist of raw materials, work in process and finished goods and are stated at the lower of cost or net realizable value, using the first-in,
first-out method as a cost flow method.
Property
and Equipment
The
Company records property and equipment at cost. Property and equipment is depreciated using the straight-line method over the estimated
economic lives of the assets, which are from 3 to 10 years. The Company capitalizes the expenditures for major renewals and improvements
that extend the useful lives of property and equipment. Expenditures for maintenance and repairs are charged to expense as incurred.
The Company reviews the carrying value of long-lived assets for impairment at least annually or whenever events or changes in circumstances
indicate that the carrying amount of an asset may not be recoverable. The recoverability of long-lived assets is measured by a comparison
of its carrying amount to the undiscounted cash flows that the asset or asset group is expected to generate. If such assets are considered
impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the property, if any, exceeds its
fair market value.
Long-
Lived Assets
Long-lived
assets and certain identifiable assets related to those assets are periodically reviewed for impairment whenever circumstances and situations
change such that there is an indication that the carrying amounts may not be recoverable. If the non-discounted future cash flows of
the asset are less than their carrying amount, their carrying amounts are reduced to fair value and an impairment loss recognized. There
was no impairment recorded during the six months ended June 30, 2023, and 2022.
Fair
Value of Financial Instruments
ASC
825-10-50, “Disclosures about Fair Value of Financial Instruments,” requires disclosure of the fair value of certain financial
instruments. The carrying value of cash and cash equivalents, accounts payable and borrowings, as reflected in the balance sheets, approximate
fair value because of the short-term maturity of these instruments.
Effective
January 1, 2008, the Company adopted ASC 820-10, “Fair Value Measurements”, which provides a framework for measuring fair
value under GAAP. ASC 820-10 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability
(an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants
on the measurement date. ASC 820-10 requires that valuation techniques maximize the use of observable inputs and minimize the use of
unobservable inputs.
Income
Taxes
The
Company is subject to income taxes in the United States and its domestic tax liabilities are subject to the allocation of expenses in
multiple state jurisdictions. The Company uses the asset and liability method to account for income taxes. Under this method, deferred
income tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement
carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured
using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered
or settled. The recoverability of deferred tax assets is evaluated by assessing the adequacy of future expected taxable income from all
sources, including taxable income in prior carryback years, reversal of taxable temporary differences, forecasted operating earnings
and available tax planning strategies. To the extent the Company does not consider it more-likely-than-not that a deferred tax asset
will be recovered, a valuation allowance is established.
Concentration
of Credit Risk
Cash
includes amounts deposited in financial institutions in excess of insurable Federal Deposit Insurance Corporation (“FDIC”)
limits. As of June 30, 2023, the Company did not have cash balances in excess of FDIC limits.
Revenue
Recognition
The
Company recognizes revenue on arrangements in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”).
The core principle of ASC 606 is to recognize revenues when promised goods or services are transferred to customers in an amount that
reflects the consideration to which an entity expects to be entitled for those goods or services ASC 606 requires companies to assess
their contracts to determine the timing and amount of revenue to recognize under the new revenue standard. The model has a five-step
approach:
1. |
Identify the contract with
the customer. |
|
|
2. |
Identify the performance
obligations in the contract. |
|
|
3. |
Determine the total transaction
price. |
|
|
4. |
Allocate the total transaction
price to each performance obligation in the contract. |
|
|
5. |
Recognize as revenue when
(or as) each performance obligation is satisfied. |
Revenue
generated from the sale of INVOcell is typically recognized at the time the product is shipped, at which time the title passes to the
customer, and there are no further performance obligations.
Revenue
generated from clinical and lab services related at the Company’s affiliated INVO Centers is typically recognized at the time the
service is performed.
Stock
Based Compensation
The
Company accounts for stock-based compensation under the provisions of Accounting Standards Codification (“ASC”) subtopic
718-10, Compensation (“ASC 718-10”). This statement requires the Company to measure the cost of employee services received
in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized over the period
in which the employee is required to provide service or based on performance goals in exchange for the award, which is usually the vesting
period.
Loss
Per Share
Basic
loss per share calculations are computed by dividing net loss by the weighted-average number of common shares outstanding. Diluted earnings
per share are computed similar to basic earnings per share except that the denominator is increased to include potentially dilutive securities.
The Company’s diluted loss per share is the same as the basic loss per share for the three and six months ended June 30, 2023,
and 2022, as the inclusion of any potential shares would have had an anti-dilutive effect due to the Company generating a loss.
Schedule of Earnings Per Share Basic and Diluted
| |
| | |
| | |
| | |
| |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net loss (numerator) | |
$ | (2,240,511 | ) | |
| (2,801,541 | ) | |
| (4,791,390 | ) | |
| (5,575,853 | ) |
Basic and diluted weighted-average number of common shares outstanding (denominator) | |
| 732,255 | | |
| 605,760 | | |
| 677,684 | | |
| 604,123 | |
Basic weighted-average number of common shares outstanding (denominator) | |
| 732,255 | | |
| 605,760 | | |
| 677,684 | | |
| 604,123 | |
Basic and diluted net loss per common share | |
| (3.06 | ) | |
| (4.62 | ) | |
| (7.07 | ) | |
| (9.23 | ) |
Basic net loss per common share | |
| (3.06 | ) | |
| (4.62 | ) | |
| (7.07 | ) | |
| (9.23 | ) |
The
Company has excluded the following dilutive securities from the calculation of fully diluted shares outstanding because the result would
have been anti-dilutive:
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share
| |
| | |
| |
| |
As of June 30, | |
| |
2023 | | |
2022 | |
Options | |
| 121,255 | | |
| 74,480 | |
Convertible notes and interest | |
| 55,120 | | |
| - | |
Unit purchase options and warrants | |
| 348,151 | | |
| 13,008 | |
Total | |
| 524,526 | | |
| 87,488 | |
Recently
Adopted Accounting Pronouncements
The
Company has reviewed all recently issued, but not yet effective, accounting pronouncements, and does not believe the future adoption
of any such pronouncements will have a material impact on its financial condition or the results of its operations.
Note
2 – Liquidity
Historically,
the Company has funded its cash and liquidity needs primarily through revenue collection, equity financings, and convertible notes. For
the six months ended June 30, 2023, and 2022, the Company incurred a net loss of approximately $4.8 million and $5.6 million, respectively,
and has an accumulated deficit of approximately $54.6 million as of June 30, 2023. Approximately $1.4 million of the net loss was related
to non-cash expenses for the six months ended June 30, 2023, compared to $1.6 million for the six months ended June 30, 2022.
The
Company has been dependent on raising capital from debt and equity financings to meet its needs for cash flow used in operating and investing
activities. During the first six months of 2023, the Company received net proceeds of approximately $2.7 million for the sale of its
common stock par value $0.0001 per share (“Common Stock”) as well as approximately $0.7 million from the sale of convertible
notes. During the first six months of 2022, the Company received proceeds of approximately $0.3 million for the sale of Common Stock.
Over the next 12 months, the Company’s plan includes opening additional INVO Centers, completing the acquisition of Wisconsin Fertility
Institute and pursuing additional IVF clinic acquisitions. Until the Company can generate positive cash from operations, it will need
to raise additional funding to meet its liquidity needs and to execute its business strategy. As in the past, the Company will seek debt
and/or equity financing, which may not be available on reasonable terms, if at all.
Although
the Company’s audited financial statements for the year ended December 31, 2022 were prepared under the assumption that it would
continue operations as a going concern, the report of the Company’s independent registered public accounting firm that accompanies
the Company’s financial statements for the year ended December 31, 2022 contains a going concern qualification in which such firm
expressed substantial doubt about the Company’s ability to continue as a going concern, based on the financial statements at that
time. Specifically, as noted above, the Company has incurred significant operating losses and the Company expects to continue to incur
significant expenses and operating losses as it continues to ramp up the commercialization of INVOcell and develop new INVO Centers.
These prior losses and expected future losses have had, and will continue to have, an adverse effect on the Company’s financial
condition. If the Company cannot continue as a going concern, its stockholders would likely lose most or all of their investment in the
Company.
Note
3 – Variable Interest Entities
Consolidated
VIEs
Bloom
INVO, LLC
On
June 28, 2021, INVO CTR entered into a limited liability company agreement (the “Bloom Agreement”) with Bloom Fertility,
LLC (“Bloom”) to establish a joint venture entity, formed as “Bloom INVO LLC” (the “Georgia JV”),
for the purposes of commercializing INVOcell, and the related IVC procedure, through the establishment of an INVO Center (the “Atlanta
Clinic”) in the Atlanta, Georgia metropolitan area.
In
consideration for INVO’s commitment to contribute up to $800,000 within the 24-month period following the execution of the Bloom
Agreement to support the start-up operations of the Georgia JV, the Georgia JV issued 800 of its units to INVO CTR and in consideration
for Bloom’s commitment to contribute physician services having an anticipated value of up to $1,200,000 over the course of a 24-month
vesting period, the Georgia JV issued 1,200 of its units to Bloom.
The
responsibilities of Bloom include providing all medical services required for the operation of the Atlanta Clinic. The responsibilities
of INVO CTR include providing certain funding to the Georgia JV, lab services quality management, and providing access to and being the
exclusive provider of the INVOcell to the Georgia JV. INVO CTR also performs all required, industry specific compliance and accreditation
functions, and product documentation for product registration.
The
Bloom Agreement provides Bloom with a “profits interest” in the Georgia JV and, in connection with such profits interest,
states that profits and losses be allocated to its members based on a hypothetical liquidation of the Georgia JV. In such a scenario,
liquidation proceeds would be distributed in the following order: (a) to INVO CTR until the difference between its capital contributions
and distributions equals $0; (b) to Bloom until its distributions equal 150% of the liquidation amounts distributed to INVO CTR (a “catch-up”
to rebalance the distributions between members); and (c) thereafter on a pro rata basis. The Georgia JV had no assets or liabilities
at the time the units were issued, and, as of June 30, 2023, INVO CTR had made capital contributions greater than the net loss of the
Georgia JV. As such, the entire net loss was allocated to INVO CTR, and no loss was allocated to the noncontrolling interest of Bloom.
The
Georgia JV opened to patients on September 7, 2021.
The
Company determined the Georgia JV is a VIE, and that the Company is its primary beneficiary because the Company has an obligation to
absorb losses that are potentially significant and the Company controls the majority of the activities that impact the Georgia JV’s
economic performance, specifically control of the INVOcell and lab services quality management. As a result, the Company consolidated
the Georgia JV’s results with its own. As of June 30, 2023, the Company invested $0.9 million in the Georgia JV in the form of
capital contributions as well as $0.5 million in the form of a note. For the six months ended June 30, 2023 and 2022, the Georgia JV
recorded net losses of $0.1 million and $0.3 million respectively. Noncontrolling interest in the Georgia JV was $0.
Unconsolidated
VIEs
HRCFG
INVO, LLC
On
March 10, 2021, INVO CTR entered into a limited liability company agreement with HRCFG, LLC (“HRCFG”) to form a joint venture
for the purpose of establishing an INVO Center in Birmingham, Alabama. The name of the joint venture entity is HRCFG INVO, LLC (the “Alabama
JV”). The Company also provides certain funding to the Alabama JV. Each party owns 50% of the Alabama JV.
The
Alabama JV opened to patients on August 9, 2021.
The
Company determined the Alabama JV is a VIE, and that there is no primary beneficiary. As a result, the Company will use the equity method
to account for its interest in the Alabama JV. As of June 30, 2023, the Company invested $1.6 million in the Alabama JV in the form of
a note. For the six months ended June 30, 2023, the Alabama JV recorded net income of $2 thousand, of which the Company recognized a
gain from equity method investments of $805. For the six months ended June 30, 2022, the Alabama JV recorded a net loss of $0.3 million,
of which the Company recognized a loss from equity method investments of $0.2 million.
Positib
Fertility, S.A. de C.V.
On
September 24, 2020, INVO CTR entered into a Pre-Incorporation and Shareholders Agreement with Francisco Arredondo, MD PLLC (“Arredondo”)
and Security Health LLC, a Texas limited liability company (“Ramirez”, and together with INVO CTR and Arredondo, the “Shareholders”)
under which the Shareholders will commercialize the IVC procedure and offer related medical treatments in Mexico. Each party owns one-third
of the Mexican incorporated company, Positib Fertility, S.A. de C.V. (the “Mexico JV”).
The
Mexico JV opened to patients on November 1, 2021.
The
Company determined the Mexico JV is a VIE, and that there is no primary beneficiary. As a result, the Company will use the equity method
to account for its interest in the Mexico JV. As of June 30, 2023, the Company invested $0.1 million in the Mexico JV. For the six months
ended June 30, 2023 and 2022, the Mexico JV recorded net losses of $74 thousand and $90 thousand, respectively, of which the Company
recognized a loss from equity method investments of $24 thousand and $30 thousand, respectively.
The
following table summarizes our investments in unconsolidated VIEs:
Schedule of Investments in Unconsolidated Variable Interest Entities
| |
| |
Carrying Value as of | |
| |
Location | |
Percentage Ownership | | |
June 30, 2023 | | |
December 31, 2022 | |
HRCFG INVO, LLC | |
Alabama, United States | |
| 50 | % | |
$ | 1,023,346 | | |
| 1,106,905 | |
Positib Fertility, S.A. de C.V. | |
Mexico | |
| 33 | % | |
| 109,019 | | |
| 130,960 | |
Total investment in unconsolidated VIEs | | | |
$ | 1,132,365 | | |
| 1,237,865 | |
Earnings
from investments in unconsolidated VIEs were as follows:
Schedule of Earnings from Investments in Unconsolidated Variable Interest Entities
| |
| | |
| | |
| | |
| |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
HRCFG INVO, LLC | |
$ | 19,474 | | |
$ | (104,255 | ) | |
$ | 805 | | |
$ | (159,175 | ) |
Positib Fertility, S.A. de C.V. | |
| (15,686 | ) | |
| (13,723 | ) | |
| (24,752 | ) | |
| (29,920 | ) |
Total earnings from unconsolidated VIEs | |
| 3,788 | | |
| (117,978 | ) | |
| (23,947 | ) | |
| (189,095 | ) |
The
following tables summarize the combined unaudited financial information of our unconsolidated VIEs:
Schedule of Financial Information of Investments in Unconsolidated Variable Interest Entities
| |
| | |
| | |
| | |
| |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Statements of operations: | |
| | |
| | |
| | |
| |
Operating revenue | |
$ | 458,069 | | |
$ | 166,477 | | |
$ | 807,396 | | |
$ | 336,312 | |
Operating expenses | |
| (466,184 | ) | |
| (415,665 | ) | |
| (880,050 | ) | |
| (744,421 | ) |
Net loss | |
| (8,115 | ) | |
| (249,188 | ) | |
| (72,654 | ) | |
| (408,109 | ) |
| |
| | |
| |
| |
June 30, 2023 | | |
December 31, 2022 | |
Balance sheets: | |
| | | |
| | |
Current assets | |
$ | 416,948 | | |
| 261,477 | |
Long-term assets | |
| 1,057,010 | | |
| 1,094,490 | |
Current liabilities | |
| (513,709 | ) | |
| (396,619 | ) |
Long-term liabilities | |
| (121,773 | ) | |
| (107,374 | ) |
Net assets | |
$ | 838,476 | | |
| 851,974 | |
Note
4 – Agreements and Transactions with VIE’s
The
Company sells the INVOcell to its consolidated and unconsolidated VIEs and anticipates continuing to do so in the ordinary course of
business. All intercompany transactions with consolidated entities are eliminated in the Company’s consolidated financial statements.
Per ASC 323-10-35-8 the Company eliminates any sales to an unconsolidated VIE for INVOcell inventory that the VIE still has remaining
on the books at period end.
The
following table summarizes the Company’s transactions with VIEs:
Summary of Transaction with Variable Interest Entities
| |
| | |
| | |
| | |
| |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Bloom Invo, LLC | |
| | | |
| | | |
| | | |
| | |
INVOcell revenue | |
$ | 6,000 | | |
$ | - | | |
$ | 10,500 | | |
$ | - | |
Unconsolidated VIEs | |
| | | |
| | | |
| | | |
| | |
INVOcell revenue | |
$ | 6,750 | | |
$ | 9,000 | | |
$ | 9,750 | | |
$ | 16,500 | |
The
Company had balances with VIEs as follows:
Summary of Balances with Variable Interest Entities
| |
| | |
| |
| |
June 30, 2023 | | |
December 31, 2022 | |
Bloom Invo, LLC | |
| | | |
| | |
Accounts receivable | |
$ | 12,000 | | |
| 13,500 | |
Notes payable | |
| 472,839 | | |
| 468,031 | |
Unconsolidated VIEs | |
| | | |
| | |
Accounts receivable | |
$ | 34,935 | | |
| 46,310 | |
Note
5 – Inventory
Components
of inventory are:
Schedule of Inventory
| |
June 30, 2023 | | |
December 31, 2022 | |
Raw materials | |
$ | 62,745 | | |
$ | 68,723 | |
Finished goods | |
| 217,273 | | |
| 194,879 | |
Total inventory | |
$ | 280,018 | | |
$ | 263,602 | |
Note
6 – Property and Equipment
The
estimated useful lives and accumulated depreciation for equipment are as follows as of June 30, 2023, and December 31, 2022:
Schedule of Estimated Useful Lives of Property and Equipment
|
|
Estimated
Useful Life |
|
Manufacturing equipment |
|
6 to 10 years |
|
Medical equipment |
|
7 to 10 years |
|
Office equipment |
|
3 to 7 years |
|
Schedule of Property and Equipment
| |
| | |
| |
| |
June 30, 2023 | | |
December 31, 2022 | |
Manufacturing equipment | |
$ | 132,513 | | |
$ | 132,513 | |
Medical equipment | |
| 283,065 | | |
| 283,065 | |
Office equipment | |
| 77,601 | | |
| 77,601 | |
Leasehold improvements | |
| 358,322 | | |
| 96,817 | |
Less: accumulated depreciation | |
| (192,059 | ) | |
| (153,267 | ) |
Total equipment, net | |
$ | 659,442 | | |
$ | 436,729 | |
During
the three months ended June 30, 2023, and 2022, the Company recorded depreciation expense of $19,705 and $21,630, respectively.
During
the six months ended June 30, 2023, and 2022, the Company recorded depreciation expense of $38,792 and $36,725, respectively.
Note
7 – Intangible Assets
The
Company capitalizes the initial expense related to establishing patents by country and then amortizes the expense over the life of the
patent, typically 20 years. It then expenses annual filing fees to maintain the patents. The Company regularly reviews the value of its
patents in the marketplace in proportion to the expense it must spend to maintain the patent. The Company fully impaired its patents
as of December 31, 2022.
During
the three months ended June 30, 2023, and 2022, the Company recorded amortization expenses related to patents of $nil and $452, respectively.
During
the six months ended June 30, 2023, and 2022, the Company recorded amortization expenses related to patents of $nil and $904, respectively.
The
trademarks have an indefinite life and therefore are not amortized. Trademarks are periodically reviewed for impairment whenever circumstances
and situations change such that there is an indication that the carrying amounts may not be recoverable. The Company fully impaired its
trademarks as of December 31, 2022.
Note
8 – Leases
The
Company has various operating lease agreements in place for its office and joint ventures. Per FASB’s ASU 2016-02, Leases Topic
842 (“ASU 2016-02”), effective January 1, 2019, the Company is required to report a right-of-use asset and corresponding
liability to report the present value of the total lease payments, with appropriate interest calculation. Per the terms of ASU 2016-02,
the Company can use its implicit interest rate, if known, or applicable federal rate otherwise. Since the Company’s implicit interest
rate was not readily determinable, the Company utilized the applicable federal rate, as of the commencement of the lease. Lease renewal
options included in any lease are considered in the lease term if it is reasonably certain the Company will exercise the option to renew.
The Company’s operating lease agreements do not contain any material restrictive covenants.
As
of June 30, 2023, the Company’s lease components included in the consolidated balance sheet were as follows:
Schedule of Lease Components
| |
| |
| |
Lease component | |
Balance sheet classification | |
June 30, 2023 | |
Assets | |
| |
| | |
ROU assets – operating lease | |
Other assets | |
$ | 4,004,962 | |
Total ROU assets | |
| |
$ | 4,004,962 | |
| |
| |
| | |
Liabilities | |
| |
| | |
Current operating lease liability | |
Current liabilities | |
$ | 227,026 | |
Long-term operating lease liability | |
Other liabilities | |
| 3,873,289 | |
Total lease liabilities | |
| |
$ | 4,100,315 | |
Future
minimum lease payments as of June 30, 2023 were as follows:
Schedule of Future Minimum Lease Payments
| |
| | |
2023 | |
| 156,465 | |
2024 | |
| 392,869 | |
2025 | |
| 392,688 | |
2026 | |
| 401,581 | |
2027 and beyond | |
| 4,197,510 | |
Total future minimum lease payments | |
$ | 5,541,113 | |
Less: Interest | |
| (1,440,798 | ) |
Total operating lease liabilities | |
$ | 4,100,315 | |
Note
9 – Notes Payable
Notes
payables consisted of the following:
Schedule
of Notes Payable
| |
| | |
| |
| |
June 30, 2023 | | |
December 31, 2022 | |
Less debt discount | |
| (285,961 | ) | |
| (107,356 | ) |
Related party demand notes with a 10% financing fee. 10% annual interest starting January 31, 2023. Notes are callable starting September 30, 2023 | |
$ | 770,000 | | |
$ | 770,000 | |
Convertible notes. 10% annual interest. Conversion price of $10.00-$12.00 | |
| 410,000 | | |
| 100,000 | |
Convertible debentures. 8% interest. Conversion price of $10.40 | |
| 139,849 | | |
| - | |
Less debt discount | |
| (285,961 | ) | |
| (107,356 | ) |
Total, net of discount | |
$ | 1,033,888 | | |
$ | 762,644 | |
Related
Party Demand Notes
In
the fourth quarter of 2022, the Company received $500,000 through the issuance of five demand notes (the “JAG Notes”) from
a related party, JAG Multi Investments LLC (“JAG”). The Company’s CFO is a beneficiary of JAG but does not have any
control over JAG’s investment decisions with respect to the Company. The JAG Notes accrue 10% annual interest from the date of
issuance. At maturity, the Company agreed to pay outstanding principal, a 10% financing fee and accrued interest.
In
consideration for subscribing to the JAG Note for $100,000 dated December 29, 2022, and for agreeing to extend the date on which the
other JAG Notes are callable to March 31, 2023, the Company issued JAG a warrant to purchase 17,500 shares of Common Stock. The warrant
may be exercised for a period of five (5) years from issuance at a price of $10.00 per share. The financing fees for said JAG Note and
the fair value of the warrant issued were capped at the total proceeds. The relative fair value of the warrant was recorded as a debt
discount and as of June 30, 2023 the Company had fully amortized the discount. On July 10, 2023 JAG agreed to extend the date on which
the JAG Notes are callable to September 30, 2023.
In
the fourth quarter of 2022, the Company received $200,000 through the issuance of demand promissory notes of which (1) $100,000 was received
from our chief executive officer, Steven Shum ($60,000 on November 29, 2022, $15,000 on December 2, 2022, and $25,000 on December 13,
2022) and (2) $100,000 was received from an entity controlled by our chief financial officer, Andrea Goren ($75,000 on November 29, 2022
and $25,000 on December 13, 2022). These notes accrue 10% annual interest accrues from the date of issuance. These notes are callable
with 10 days prior written notice. At maturity, the Company agreed to pay outstanding principal, a 10% financing fee and accrued interest.
The
financing fees for all demand notes were recorded as a debt discount and as of June 30, 2023 the Company had fully amortized the discount.
For
the six months ended June 30, 2023, the Company incurred $42,758 in interest related to these demand notes.
Jan
and March 2023 Convertible Notes
In
January and March 2023, the Company issued $410,000 of convertible notes, for $310,000 in cash and the conversion of $100,000 of demand
notes from the fourth quarter of 2022. These convertible notes were issued with fixed conversion prices of $10.00 (for the $275,000 issued
in January 2023) and $12.00 (for the $135,000 issued in March 2023) and (ii) 5-year warrants to purchase 19,375 shares of the Common
Stock at an exercise price of $20.00.
The
cumulative fair value of the warrants at issuance was $132,183. This was recognized as a debt discount and will be amortized on a straight-line
basis over the life of the respective notes. For the six months ending June 30, 2023 the Company amortized $59,238 of the debt discount
and as of June 30, 2023 had a remaining debt discount balance of $72,945.
Interest
on these notes accrues at a rate of ten percent (10%) per annum and is payable at the holder’s option either in cash or in shares
of the Common Stock at the conversion price set forth in the notes on December 31, 2023, unless converted earlier. For the six months
ended June 30, 2023 the Company incurred $17,456 in interest related to these convertible notes.
All
amounts due under these notes are convertible at any time after the issuance date, in whole or in part (subject to rounding for fractional
shares), at the option of the holders into the Common Stock at a fixed conversion price for the notes as described above.
February
2023 Convertible Debentures
On
February 3, and February 17, 2023, the Company entered into securities purchase agreements (the “February Purchase Agreements”)
with accredited investors (the “February Investors”) for the purchase of (i) convertible debentures of the Company in the
aggregate original principal amount of $500,000 (the “February Debentures”) for a purchase price of $450,000, (ii) warrants
(the “February Warrants”) to purchase 12,500 shares (the “February Warrant Shares”) of Common Stock at an exercise
price of $15.00 per share, and (iii) 4,167 shares of Common Stock issued as an inducement for issuing the February Debentures. The proceeds,
net of placement agent and legal fees, were used for working capital and general corporate purposes.
The
cumulative fair value of the warrants at issuance was $291,207. This was recognized as a debt discount and will be amortized on a straight-line
basis over the life of the respective notes. For the six months ending June 30, 2023 the Company amortized $86,642 of the debt discount
and as of June 30, 2023 had a remaining debt discount balance of $213,016.
Pursuant
to the February Debentures, interest on the February Debentures accrues at a rate of eight percent (8%) per annum and is payable at maturity,
one year from the date of the February Debentures. For the six months ended June 30, 2023 the Company incurred $8,444 in interest on
the February Debentures.
All
amounts due under the February Debentures are convertible at any time after the issuance date, in whole or in part, at the option of
the February Investors into Common Stock at an initial price of $10.40 per share. This conversion price is subject to adjustment for
stock splits, combinations or similar events and anti-dilution provisions, among other adjustments and is subject to a floor price.
The
Company may prepay the February Debentures at any time in whole or in part by paying a sum of money equal to 105% of the principal amount
to be redeemed, together with accrued and unpaid interest.
While
any portion of each February Debenture remains outstanding, if the Company receives cash proceeds of more than $2,000,000 (the “Minimum
Threshold”) in the aggregate from any source or series of related or unrelated sources, the February Investors shall have the right
in their sole discretion to require the Company to immediately apply up to 50% of all proceeds received by the Company above the Minimum
Threshold to repay the outstanding amounts owed under the February Debentures. The Company used $360,151 in proceeds from the RD Offering
(as described in Note 11 below) to repay a portion of the February Debentures, leaving $139,849 of the February Debentures outstanding
as of June 30, 2023. On August 8, 2023, the Company repaid the remaining balance of $139,849 with proceeds from the August Public Offering
(as described in Note 16 below).
The
February Warrants include anti-dilution protection whereby a subsequent offering priced below the February Warrants’ strike
price then in effect would entitle the February Investors to a reduction of such strike price to the price of such subsequent
offering and an increase in the February Warrant Shares determined by dividing the dollar amount for which the February Warrants are
exercisable by such lower strike price. As a result of the $2.85
strike of the August Public Offering (as described in Note 16 below), the February Warrants now entitle the February Investors to
purchase a total 65,790
at a price of $2.85
per February Warrant Share.
Note
10 – Related Party Transactions
In
the fourth quarter of 2022, the Company received $700,000 through the issuance of demand notes from related parties, as follows: (a)
$500,000 from JAG; (b) $100,000 from our chief executive officer, Steve Shum; and (c) $100,000 from our chief financial officer, Andrea
Goren. The Company’s CFO is a beneficiary of JAG but does not have any control over JAG’s investment decisions with respect
to the Company. See Note 9 of the Notes to Consolidated Financial Statements for additional information.
As
of June 30, 2023 the Company owed accounts payable to related parties totaling $142,176, primarily related to unpaid employee expense
reimbursements and unpaid board fees.
Note
11 – Stockholders’ Equity
Reverse
Stock Split
On
June 28, 2023, the Company’s board of directors approved a reverse stock split of the Company’s common stock at a ratio of
1-for-20 and also approved a proportionate decrease in its authorized common stock to 6,250,000 shares from 125,000,000. On July 26,
2023, the Company filed a certificate of change (with an effective date of July 28, 2023) with the Nevada Secretary of State pursuant
to Nevada Revised Statutes 78.209 to effectuate a 1-for-20 reverse stock split of its outstanding common stock. On July 27, 2023, the
Company received notice from Nasdaq that the reverse split would take effect at the open of business on July 28, 2023, and the reverse
stock split took effect on that date. All share information included in this Form 10-Q has been reflected as if the reverse stock split occurred as of
the earliest period presented.
February
2023 Equity Purchase Agreement
On
February 3, 2023, the Company entered into an equity purchase agreement (the “ELOC”) and registration rights agreement (the
“ELOC RRA”) with an accredited investor (the “Feb 3 Investor”) pursuant to which the Company has the right, but
not the obligation, to direct the Feb 3 Investor to purchase up to $10.0 million (the “Maximum Commitment Amount”) of shares
of Common Stock, in multiple tranches. Further, under the ELOC and subject to the Maximum Commitment Amount, the Company has the right,
but not the obligation, to submit notices to the Feb 3 Investor to purchase shares of Common Stock (i) in a minimum amount of not less
than $25,000 and (ii) in a maximum amount of up to the lesser of (a) $750,000 or (b) 200% of the Company’s average daily trading
value of the Common Stock.
Also
on February 3, 2023, the Company issued to the Feb 3 Investor 7,500 shares of Common Stock for its commitment to enter into the ELOC.
The
obligation of the Feb 3 Investor to purchase shares of Common Stock pursuant to the ELOC ends on the earlier of (i) the date on which
the purchases under the ELOC equal the Maximum Commitment Amount, (ii) 24 months after the date of the ELOC (February 3, 2025), (iii)
written notice of termination by the Company, (iv) the date that the ELOC RRA is no longer effective after its initial effective date,
or (v) the date that the Company commences a voluntary case or any person or entity commences a proceeding against the Company pursuant
to or within the meaning of federal or state bankruptcy law, a custodian is appointed for the Company or for all or substantially all
of its property, or the Company makes a general assignment for the benefit of its creditors (the “Commitment Period”).
During
the Commitment Period, the price that Feb 3 Investor will pay to purchase the shares of Common Stock that it is obligated to purchase
under the ELOC shall be 97% of the “market price,” which is defined as the lesser of (i) the lowest closing price of our
Common Stock during the 7 trading day-period following the clearance date associated with the applicable put notice from the Company
or (ii) the lowest closing bid price of the Common Stock on the principal trading market for the Common Stock (currently, the Nasdaq
Capital Market) on the trading day immediately preceding a put date.
March
2023 Registered Direct Offering
On
March 23, 2023, INVO entered into a securities purchase agreement (the “March Purchase Agreement”) with a certain
institutional investor, pursuant to which the Company agreed to issue and sell to such investor (i) in a registered direct offering
(the “RD Offering”), 69,000
shares of Common Stock, and a pre-funded warrant (the “Pre-Funded Warrant”) to purchase up to 115,000
shares of Common Stock, at an exercise price of $0.20
per share, and (ii) in a concurrent private placement (the “March Warrant Placement”), a common stock purchase warrant
(the “March Warrant”), exercisable for an aggregate of up to 276,000
shares of Common Stock, at an exercise price of $12.60
per share. The securities to be issued in the RD Offering (priced at the marked under Nasdaq rules) were offered pursuant to the
Company’s shelf registration statement on Form S-3 (File 333-255096), initially filed by the Company with the SEC under the
Securities Act of 1933, as amended (the “Securities Act”), on April 7, 2021 and declared effective on April 16, 2021.
All Pre-Funded Warrants were exercised by the investor in June 2023.
The
March Warrant (and the shares of Common Stock issuable upon the exercise of the March Warrant) was not registered under the Securities
Act and was offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of
the Securities Act and Rule 506(b) promulgated thereunder. The March Warrant is immediately exercisable upon issuance, will expire eight
years from the date of issuance, and in certain circumstances may be exercised on a cashless basis.
On
March 27, 2023, the Company closed the RD Offering and March Warrant Placement, raising gross proceeds of approximately $3 million before
deducting placement agent fees and other offering expenses payable by the Company. In the event the March Warrant is fully exercised
for cash, the Company would receive additional gross proceeds of approximately $3.5 million. Under the March Purchase Agreement, the
Company may use a portion of the net proceeds of the offering to (a) repay February Debentures, and (b) to pay the down payment for Wisconsin
Fertility acquisition. The remainder of the net proceeds will be used for working capital, capital expenditures, and other general corporate
purposes. The Company used $383,879 in proceeds to repay a portion of the February Debentures and related fees and interest and the remainder
of the proceeds are being used for working capital and general corporate purposes.
Under
the March Purchase Agreement, the Company is required within 30 days of the closing date of the March Warrant Placement to file a registration
statement on Form S-1 (the “Resale Registration Statement”) registering the resale of the shares of Common Stock issuable
upon the exercise of the March Warrant. The Company is required to use commercially reasonable efforts to cause such registration to
become effective within 75 days of the closing date of the offering (or 120 days if the registration statement is subject to a full review
by the SEC), and to keep the Resale Registration Statement effective at all times until no shares of Common Stock remain exercisable
under the March Warrant.
In
addition, pursuant to certain “lock-up” agreements, our officers and directors have agreed, for a period of 180 days from
the date of the RD Offering and March Warrant Placement, not to engage in any of the following, whether directly or indirectly, without
the consent of the March Purchase Agreement investor: offer to sell, sell, contract to sell pledge, grant, lend, or otherwise transfer
or dispose of our common stock or any securities convertible into or exercisable or exchangeable for Common Stock (the “Lock-Up
Securities”); enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences
of ownership of the Lock-Up Securities; make any demand for or exercise any right or cause to be filed a registration statement, including
any amendments thereto, with respect to the registration of any Lock-Up Securities; enter into any transaction, swap, hedge, or other
arrangement relating to any Lock-Up Securities subject to customary exceptions; or publicly disclose the intention to do any of the foregoing.
Six
Months Ended June 30, 2023
During
the six months ended June 30, 2023, the Company issued 3,994 shares of Common Stock to employees and directors and 12,202 shares of Common
Stock to consultants with a fair value of $51,565 and $106,176, respectively. The shares were issued under the Company’s 2019 Stock
Incentive Plan (the “2019 Plan”).
During
the six months ended June 30, 2023, the Company issued 297 shares of Common Stock upon the exercise of options. The Company received
proceeds of $2,375.
In
February 2023, the Company issued 4,167 shares of Common Stock with a fair value of $56,313 as inducement for issuing the February Debentures.
The fair value of the shares was recognized as a discount to the February Debentures and will be amortized over the life of the notes.
In
February 2023, the Company 7,500 shares of Common Stock in connection with the ELOC with a fair value of $93,000 that was expensed in
the period.
In
March 2023, the Company issued 69,000 shares of Common Stock in the RD Offering and March Warrant Placement. The Company received net
proceeds of approximately $2.7 million.
In
May 2023, the Company issued 6,115 shares of Common Stock to consultants in consideration of services rendered with a fair value of $45,000.
These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended.
The Company did not receive any cash proceeds from this issuance.
Note
12 – Equity-Based Compensation
Equity
Incentive Plans
In
October 2019, the Company adopted the 2019 Plan. Under the 2019 Plan, the Company’s board of directors is authorized to grant stock
options to purchase Common Stock, restricted stock units, and restricted shares of Common Stock to its employees, directors, and consultants.
The 2019 Plan initially provided for the issuance of 25,000 shares. A provision in the 2019 Plan provides for an automatic annual increase
equal to 6% of the total number of shares of Common Stock outstanding on December 31 of the preceding calendar year. In January 2023,
the number of available shares increased by 36,498 shares bringing the total shares available under the 2019 Plan to 125,000.
Options
granted under the 2019 Plan generally have a life of 3 to 10 years and exercise prices equal to or greater than the fair market value
of the Common Stock as determined by the Company’s board of directors. Vesting for employees typically occurs over a three-year
period.
The
following table sets forth the activity of the options to purchase Common Stock under the 2019 Plan.
Schedule of Stock Options Activity
| |
Number of Shares | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
Outstanding as of December 31, 2022 | |
| 64,850 | | |
$ | 68.00 | | |
$ | - | |
Granted | |
| 59,048 | | |
| 7.74 | | |
| - | |
Exercised | |
| (297 | ) | |
| 8.00 | | |
| - | |
Canceled | |
| (2,346 | ) | |
| 72.38 | | |
| - | |
Balance as of June 30, 2023 | |
| 121,255 | | |
$ | 2.10 | | |
$ | - | |
Exercisable as of June 30, 2023 | |
| 71,251 | | |
$ | 62.42 | | |
$ | - | |
The
fair value of each option granted is estimated as of the grant date using the Black-Scholes option pricing model with the following assumptions:
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions
| |
| Six months ended June 30, |
| |
| 2023 | | |
| 2022 | |
Risk-free interest rate range | |
| 3.6-3.69 % | | |
| 1.6 to 1.9 % | |
Expected life of option-years | |
| 5-5.63 | | |
| 5.25 to 5.75 | |
Expected stock price volatility | |
| 106.6-114.9 % | | |
| 110.4 to 113.2 % | |
Expected dividend yield | |
| - | % | |
| - | % |
The
risk-free interest rate is based on U.S. Treasury interest rates, the terms of which are consistent with the expected life of the stock
options. Expected volatility is based upon the average historical volatility of the Common Stock over the period commensurate with the
expected term of the related instrument. The expected life and estimated post-employment termination behavior is based upon historical
experience of homogeneous groups, executives and non-executives, within the Company. The Company does not currently pay dividends on
its Common Stock, nor does it expect to do so in the foreseeable future.
Schedule of Share Based Payments Arrangements Options Exercised and Options Vested
| |
Total Intrinsic Value of Options Exercised | | |
Total Fair Value of Options Vested | |
Year ended December 31, 2022 | |
$ | - | | |
$ | 1,616,401 | |
Six months ended June 30, 2023 | |
$ | - | | |
$ | 654,925 | |
For
the six months ended June 30, 2023, the weighted average grant date fair value of options granted was $6.38 per share. The Company estimates
the fair value of options at the grant date using the Black-Scholes model. For all stock options granted through June 30, 2023, the weighted
average remaining service period is 1 year.
Restricted
Stock and Restricted Stock Units
In
the six months ended June 30, 2023, the Company granted 13,272 restricted stock units and shares of restricted stock to certain employees,
directors, and consultants under the 2019 Plan. Restricted stock issued to employees, directors, and consultants generally vest either
at grant or vest over a period of one year from the date of grant.
The
following table summarizes the Company’s restricted stock awards activity under the 2019 Plan during the six months ended June
30, 2023:
Schedule of Aggregate Restricted Stock Awards and Restricted Stock Unit Activity
| |
Number of Unvested Shares | | |
Weighted Average Grant Date Fair Value | | |
Aggregate Value of Shares | |
| |
| | |
| | |
| |
Balance as of December 31, 2022 | |
| 3,533 | | |
$ | 8.40 | | |
$ | 29,949 | |
Granted | |
| 13,272 | | |
| 8.88 | | |
| 97,172 | |
Vested | |
| (16,505 | ) | |
| 18.82 | | |
| 286,597 | |
Forfeitures | |
| - | | |
| - | | |
| - | |
Balance as of June 30, 2023 | |
| 300 | | |
| 18.42 | | |
| 5,525 | |
Note
13 – Unit Purchase Options and Warrants
The
following table sets forth the activity of unit purchase options:
Schedule
of Unit Purchase Stock Options Activity
| |
Number of Unit Purchase Options | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
Outstanding as of December 31, 2022 | |
$ | 4,649 | | |
$ | 64.00 | | |
$ | - | |
Granted | |
| - | | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | | |
| - | |
Canceled | |
| - | | |
| - | | |
| - | |
Balance as of June 30, 2023 | |
$ | 4,649 | | |
$ | 64.00 | | |
$ | - | |
The
following table sets forth the activity of warrants:
Schedule
of Warrants Activity
| |
Number of Warrants | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
Outstanding as of December 31, 2022 | |
| 25,864 | | |
$ | 30.20 | | |
$ | - | |
Granted | |
| 432,618 | | |
| 12.60 | | |
| - | |
Exercised | |
| (115,000 | ) | |
| 0.20 | | |
| - | |
Canceled | |
| - | | |
| - | | |
| - | |
Balance as of June 30, 2023 | |
| 378,849 | | |
$ | 20.41 | | |
$ | - | |
Note
14 – Income Taxes
The
Company uses the asset and liability method to account for income taxes. Under this method, deferred income tax assets and liabilities
are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing
assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected
to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred
tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. If a carryforward
exists, the Company decides as to whether the carryforward will be utilized in the future. Currently, a valuation allowance is established
for all deferred tax assets and carryforwards as their recoverability is deemed to be uncertain. If the Company’s expectations
for future operating results at the federal or at the state jurisdiction level vary from actual results due to changes in healthcare
regulations, general economic conditions, or other factors, it may need to adjust the valuation allowance, for all or a portion of the
Company’s deferred tax assets. The Company’s income tax expense in future periods will be reduced or increased to the extent
of offsetting decreases or increases, respectively, in the Company’s valuation allowance in the period when the change in circumstances
occurs. These changes could have a significant impact on the Company’s future earnings.
Income
tax expense was $2,865 for the three and six months ended June 30, compared to $800 for the three and six months ended June 30, 2022.
The annual forecasted effective income tax rate for 2023 is 0%, with a year-to-date effective income tax rate for the six months ended
June 30, 2023, of 0%.
Note
15 – Commitments and Contingencies
Insurance
The
Company’s insurance coverage is carried with third-party insurers and includes: (i) general liability insurance covering third-party
exposures; (ii) statutory workers’ compensation insurance; (iv) excess liability insurance above the established primary limits
for general liability and automobile liability insurance; (v) property insurance, which covers the replacement value of real and personal
property and includes business interruption; and (vi) insurance covering our directors and officers for acts related to our business
activities. All coverage is subject to certain limits and deductibles, the terms and conditions of which are common for companies with
similar types of operations.
Legal
Matters
The
Company is not currently subject to any material legal proceedings; however, it could be subject to legal proceedings and claims from
time to time in the ordinary course of its business, or legal proceedings it considered immaterial may in the future become material.
Regardless of the outcome, litigation can, among other things, be time consuming and expensive to resolve, and can divert management
resources.
Note
16 – Subsequent Events
On
July 11, 2023, the Company issued 16,250
shares of Common Stock in consideration of a settlement with an unrelated third party. These shares were issued pursuant to the exemption from registration provided
by Section 4(a)(2) of the Securities Act of 1933, as amended. The Company did not receive any cash proceeds from this issuance.
On August 8, 2023, the Company issued 26,391 shares of Common Stock upon
exercise of an existing warrant on a net-exercise basis. These shares were issued pursuant to the exemption from registration provided
by Section 4(a)(2) and/or 3(a)(9) of the Securities Act of 1933, as amended.
Reverse
Stock Split
On
July 28, 2023 the Company effected a 1-for-20
reverse stock split of its outstanding common stock, please see Note 11 for more details. The Company issued an additional 135 shares of Common Stock for fractional shares.
Amendment
to Armistice SPA
On
July 7, 2023, the Company entered into an Amendment to Securities Purchase Agreement (the “Armistice Amendment”) with Armistice
Capital Markets Ltd. to delete Section 4.12(a) of our March 23, 2023 Securities Purchase Agreement (the “Armistice SPA”)
with Armistice pursuant to which the Company agreed that from March 23, 2023 until 45 days after the effective date of the Resale Registration
Statement (as defined below) the Company would not (i) issue, enter into any agreement to issue or announce the issuance or proposed
issuance of any shares of Common Stock or Common Stock Equivalents or (ii) file any registration statement or any amendment or supplement
thereto, other than the prospectus supplement filed in connection with that offering and the Resale Registration Statement (the “Subsequent
Equity Financing Provision”). In consideration of Armistice’s agreement to enter into the Armistice Amendment and delete
the Subsequent Equity Financing Provision from the Armistice SPA, the Company agreed to pay Armistice a fee a $1,000,000 (the “Armistice
Amendment Fee”) within two days of the closing of this Offering. Additionally, the Company agreed to include a proposal in its
proxy statement for its 2023 Annual Meeting of Stockholders for the purpose of obtaining the approval of the holders of a majority of
our outstanding voting common stock, to effectuate the reduction of the exercise price set forth in Section 2(b) of the Common Stock
Purchase Warrants issued to Armistice on March 27, 2023 (the “Existing Warrants”) to the per unit public offering price of
this Offering, in accordance with Nasdaq Rule 5635(d) (the “Shareholder Approval”) with the recommendation of the Company’s
board of directors that such proposal be approved. The Company also agreed to solicit proxies from its shareholders in connection therewith
in the same manner as all other management proposals in such proxy statement and that all management-appointed proxyholders shall vote
their proxies in favor of such proposal. Further, if the Company does not obtain Shareholder Approval at the first meeting, the Company
will call a meeting every six (6) months thereafter to seek Shareholder Approval until the earlier of the date Shareholder Approval is
obtained or the Existing Warrants are no longer outstanding. Until such approval is obtained, the exercise price of the Existing Warrants
will remain unchanged. The Armistice Amendment Fee was paid concurrent with closing of the August 2023 Public Offering on August 8, 2023.
JAG
Demand Note
On
July 10, 2023, the Company entered into a letter agreement (the “Agreement”) with JAG Multi Investments LLC (“JAG”),
a related party to Andrea Goren, the Company’s CFO, who is a beneficiary of JAG but does not have any control over JAG’s
investment decisions with respect to the Company. In the Agreement, the Company and JAG agreed that (1) JAG would loan the Company $100,000
under a demand promissory note, (2) the date on which JAG can demand payment of principal, fees and any interest under those certain
demand promissory previously issued to JAG by the Company for a total of $500,000, of which JAG may demand payment of $500,000 as of
the date hereof, be extended to September 30, 2023.
July
2023 Standard Merchant Cash Advance Agreement
On
July 19, 2023, the Company entered into a Standard Merchant Cash Advance Agreement with Cedar Advance LLC (“Cedar”) under
which Cedar purchased $543,750 of our receivables for a gross purchase price of $375,000. The Company received net proceeds of $356,250.
Until the purchase price has been repaid, the Company agreed to pay Cedar $19,419.64 per week. If the Company repays the purchase price
within 30-days then the amount payable shall be reduced to $465,000. In addition, the Company granted Cedar a security interest in its
accounts, including deposit accounts and accounts receivable. The Company intends to use the proceeds for working capital and general
corporate purposes.
Notices
from Nasdaq of Failure to Satisfy Continued Listing Rules.
On
July 11, 2023, the Company received a notice from the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market
LLC (“Nasdaq”) that, based upon the Company’s non-compliance with the minimum bid price requirement set forth in Nasdaq
Listing Rule 5550(a)(2) (the “Rule”), as of July 10, 2023, the Nasdaq Hearing Panel (the “Panel”) will consider
such non-compliance in its decision regarding the Company’s continued listing on Nasdaq.
The
Company plans to timely submit to the Panel confirmation of its plan to regain compliance under the Rule, providing similar information
to that presented to the Panel at the Company’s hearing on July 6, 2023.
As
previously disclosed, the Company was granted a 180-day grace period to regain compliance with the Rule through July 10, 2023. The Company
was unable to do so by that date, which resulted in the issuance of the Staff’s notice.
On
July 27, 2023, the Company received a letter from the Panel under which they granted its request for continued listing of Nasdaq subject
to us demonstrating compliance with the Equity Rule as well as Nasdaq Listing Rule 5550(a)(2) (to maintain a minimum bid price of $1;
the “Price Rule”) on or before September 29. 2023. The Panel reserves the right to reconsider the terms of this exception
based on any event, condition or circumstance that exists or develops that would, in the opinion of the Panel, make continued listing
of our securities on Nasdaq inadvisable or unwarranted. In that regard, the Panel advises the Company that it is a requirement during
the exception period that the Company provide prompt notification of any significant events that occur during this time that may affect
its compliance with Nasdaq requirements. This includes, but is not limited to, prompt advance notice of any event that may call into
question its ability to meet the terms of the exception granted.
August
2023 Public Offering
On
August 4, 2023, the Company, entered into securities purchase agreements (the “Purchase Agreements”) with certain institutional
and other investors, pursuant to which the Company agreed to issue and sell to such investors in a public offering (the “Offering”),
1,580,000 units (the “Units”) with each Unit consisting of (i) one share (the “Shares”) of Common Stock of the
Company, and (ii) two common stock purchase warrants (the “Warrants”), each exercisable for one share of Common Stock at
an exercise price of $2.85 per share, for an aggregate of 1,580,000 Shares and Warrants to purchase 3,160,000 shares of Common Stock
being sold in the Offering, at a price of $2.85 per Unit. The securities to be issued in the Offering were offered pursuant to the Company’s
registration statement on Form S-1 (File 333-273174) (the “Registration Statement”), initially filed by the Company with
the Securities and Exchange Commission (the “SEC”) under the Securities Act of 1933, as amended (the “Securities Act”),
on July 7, 2023 and declared effective on August 3, 2023.
The
Company closed the Offering on August 8, 2023, raising gross proceeds of approximately $4.5
million before deducting placement agent fees and other offering expenses payable by the Company. The Company used (i) $2,150,000
of the net proceeds to fund the initial installment of the purchase price required to consummate the acquisition of the Wisconsin
Fertility Institute (net of a $350,000 holdback)
on August 10, 2023; (ii) $1,000,000 of
the net proceeds of this offering to pay Armistice the Armistice Amendment Fee for agreeing to remove the Subsequent Equity
Financing Provision from the Armistice SPA; (iii) $100,000 to
repay that certain 8%
Debenture with a maturity date of February
3, 2024 issued to Peak One Opportunity Fund
LP plus accrued interest and fees of approximately $7,784;
and (iv) $39,849 to
repay that certain 8%
Debenture with a maturity date of February
17, 2024 issued to First Fire Global
Opportunities Fund, LLC, plus accrued interest and fees of approximately $3,127.
The Company intends to use the remaining net proceeds from this offering for working capital and general corporate
purposes.
Also
in connection with the offering, on August 4, 2023, the Company entered into a placement agency agreement (the “Placement
Agency Agreement”) with Maxim Group LLC (the “Placement Agent”), pursuant to which (i) the Placement Agent agreed
to act as placement agent on a “best efforts” basis in connection with the Offering and (ii) the Company agreed to pay
the Placement Agent an aggregate fee equal to 7.0% of the gross proceeds (and 5% for certain investors) raised in the offering and
warrants to purchase up to 110,600 shares of Common Stock at an exercise price of $3.14 (the “Placement Agent
Warrants”). The Placement Agent Warrants (and the shares of Common Stock issuable upon the exercise of the Placement Agent
Warrants) were not registered under the Securities Act and were offered pursuant to an exemption from the registration requirements
of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder.
Wisconsin
Fertility Institute Acquisition
On
August 10, 2023, the Company, through Wood Violet Fertility LLC, a Delaware limited liability company (“Buyer”) and wholly
owned subsidiary of INVO Centers LLC, a Delaware company wholly-owned by INVO, consummated its acquisition of the Wisconsin Fertility
Institute (the “Clinic”) for a combined purchase price of $10 million, of which $2.5 million was paid on the closing date
(net $2,150,000 after a $350,000 holdback) plus assumption of the inter-company loan owed by WFRSA in the amount of $528,756 and the
remaining three installments of $2.5 million each will be paid on the subsequent three anniversaries of closing. The sellers have the
option to take all or a portion of the final three installments in shares of INVO common stock valued at $125.00, $181.80, and $285.80,
for the second, third, and final installments, respectively.
The
Clinic is comprised of (a) a medical practice, Wisconsin Fertility and Reproductive Surgery Associates, S.C., a Wisconsin professional
service corporation d/b/a Wisconsin Fertility Institute (“WFRSA”), and (b) a laboratory services company, Fertility Labs
of Wisconsin, LLC, a Wisconsin limited liability company (“FLOW”). WFRSA owns, operates and manages the Clinic’s fertility
practice that provides direct treatment to patients focused on fertility, gynecology and obstetrics care and surgical procedures, and
employs physicians and other healthcare providers to deliver such services and procedures. FLOW provides WFRSA with related laboratory
services.
INVO
is purchasing the non-medical assets of WFRSA and one hundred percent of FLOW’s membership interests. As reflected in the WFRSA
purchase agreement, the Buyer and WFRSA will enter into a management services agreement pursuant to which WFRSA will outsource all its
non-medical activities to the Buyer.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You
should read the following discussion and analysis of our financial condition and results of operations together with our financial statements
and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q. In addition to historical information, this discussion
and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially
from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified
below, and those discussed in the section titled “Risk Factors” included in our Annual Report on Form 10-K for the fiscal
year ended December 31, 2022 as may be amended, supplemented or superseded from time to time by other reports we file with the SEC. All
amounts in this report are in U.S. dollars, unless otherwise noted.
Throughout
this Quarterly Report on Form 10-Q, references to “we,” “our,” “us,” the “Company,” “INVO,”
or “INVO Bioscience, Inc.” refer to INVO Bioscience, Inc.
Overview
We
are a healthcare services fertility company dedicated to expanding the assisted reproductive technology (“ART”) marketplace
by making fertility care accessible and inclusive to people around the world. Our commercialization strategy is focused on the opening
of dedicated “INVO Centers” offering the INVOcell® and IVC procedure (with three centers in North America now operational),
the acquisition of US-based, profitable in vitro fertilization (“IVF”) clinics and the sale and distribution of our technology
solution into existing fertility clinics. Our proprietary technology, INVOcell®, is a revolutionary medical device that allows fertilization
and early embryo development to take place in vivo within the woman’s body. This treatment solution is the world’s first
intravaginal culture technique for the incubation of oocytes and sperm during fertilization and early embryo development. This technique,
designated as “IVC”, provides patients with a more natural, intimate, and more affordable experience in comparison to other
ART treatments. We believe the IVC procedure can deliver comparable results at a fraction of the cost of traditional IVF and is a significantly
more effective treatment than intrauterine insemination (“IUI”).
Unlike
IVF where the oocytes and sperm develop into embryos in an expensive laboratory incubator, the INVOcell allows fertilization and early
embryo development to take place in the woman’s body. This allows for many benefits in the IVC procedure, including:
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Reduces expensive and time-consuming lab procedures,
helping clinics and doctors to increase patient capacity and reduce costs; |
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Provides a natural, stable incubation environment; |
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● |
Offers a more personal, intimate experience in creating
a baby; and |
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Reduces the risk of errors and wrong embryo transfers. |
In
both current utilization of the INVOcell, and in clinical studies, the IVC procedure has demonstrated equivalent pregnancy success and
live birth rates as IVF.
While
the INVOcell remains important to our efforts, our commercialization and corporate development strategy has expanded to focus primarily
on providing ART services to the significantly underserved patient population seeking access to affordable fertility treatment. The Company
is now largely focused on the opening of dedicated “INVO Centers” offering the INVOcell and IVC procedure (with three centers
in North America now operational) and the acquisition of existing IVF clinics, in addition to continuing to distribute and sell our technology
solution to existing fertility clinics.
On August 10, 2023 we closed our first acquisition, Wisconsin Fertility
Institute (“WFI”). The acquisition of WFI is expected to provide significant scale to our operations and complement our INVO
Center strategy. The Madison-based fertility center primarily offers conventional IVF procedures and generated more than $5 million in
revenue and approximately $1.7 million of net income based on fiscal 2022 audited results.
Operations
We
operate with a core internal team and outsource certain operational functions in order to help advance our efforts as well as reduce
fixed internal overhead needs and costs and in-house capital equipment requirements. Our most critical management and leadership functions
are carried out by our core management team. We have contracted out the manufacturing, assembly, packaging, labeling, and sterilization
of the INVOcell device to a medical manufacturing company and a sterilization specialist to perform the gamma sterilization process.
To
date, we have completed a series of important steps in the successful development and manufacturing of the INVOcell:
● |
Manufacturing:
we are ISO 13485:2016 certified and manage all aspects of production and manufacturing with qualified suppliers. Our key suppliers
have been steadfast partners since our company first began and can provide us with virtually an unlimited capability to support our
growth objectives, with all manufacturing performed in the New England region of the U.S.. |
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Raw
Materials: all raw materials utilized for the INVOcell are medical grade and commonly used in medical devices (e.g., medical
grade silicone, medical grade plastic). Our principal molded component suppliers are well-established companies in the molding industry
and are either ISO 13485 or ISO 9001 certified. The molded components are supplied to our contract manufacturer for assembly and
packaging of the INVOcell system. The contract manufacturer is ISO 13485 certified, and U.S. Food & Drug Administration (“FDA”)
registered. |
● |
CE
Mark: INVO Bioscience received the CE Mark in October 2019. The CE Mark permits the sale of devices in Europe, Australia and
other countries that recognize the CE Mark, subject to local registration requirements. |
● |
US
Marketing Clearance: the safety and efficacy of the INVOcell has been demonstrated and cleared for marketing and use by the FDA
in November 2015. |
● |
Clinical:
In June 2023 we received FDA 510(k) clearance to expand the labeling on the INVOcell device and its indication for use to provide for
a 5-day incubation period. The data supporting the expanded 5-day incubation clearance demonstrated improved patient outcomes. |
Market
Opportunity
The
global ART marketplace is a large, multi-billion industry growing at a strong pace in many parts of the world as increased infertility
rates, increased patient awareness, acceptance of treatment options, and improving financial incentives such as insurance and governmental
assistance continue to drive demand. According to the European Society for Human Reproduction 2020 ART Fact Sheet, one in six couples
worldwide experience infertility problems. Additionally, the worldwide market remains vastly underserved as a high percentage of patients
in need of care continue to go untreated each year for many reasons, but key among them are capacity constraints and cost barriers. While
there have been large increases in the use of IVF, there are still only approximately 2.6 million ART cycles, including IVF, IUI and
other fertility treatments, performed globally each year, producing around 500,000 babies. This amounts to less than 3% of the infertile
couples worldwide being treated and only 1% having a child though IVF. The industry remains capacity constrained which creates challenges
in providing access to care to the volume of patients in need. A survey by “Resolve: The National Infertility Association,”
indicates the two main reasons couples do not use IVF is cost and geographical availability (and/or capacity).
In
the United States, infertility, according to the American Society of Reproductive Medicine (2017), affects an estimated 10%-15% of the
couples of childbearing-age. According to the Centers for Disease Control (“CDC”), there are approximately 6.7 million women
with impaired fertility. Based on preliminary 2020 data from CDC’s National ART Surveillance System, approximately 326,000 IVF
cycles were performed at 449 IVF centers, leaving the U.S. with a large, underserved patient population, similar to most markets around
the world.
As
part of the expanded corporate expansion efforts the Company has incorporated an acquisition strategy to the business. The Company estimates
that there are approximately 80 to 100 established owner-operated IVF clinics that may represent suitable acquisitions as part of this
additional effort.
Competitive
Advantages
We
believe that the INVOcell, and the IVC procedure it enables, have the following key advantages:
Lower
cost than IVF with equivalent efficacy. The IVC procedure can be offered for less than IVF due to lower cost of supplies, labor,
capital equipment and general overhead. The laboratory equipment needed to perform an IVF cycle is expensive and requires ongoing costs
as compared to what is required for an IVC cycle. As a result, we also believe INVOcell and the IVC procedure enable a clinic and its
laboratory to be more efficient as compared to conventional IVF.
The
IVC procedure is currently being offered at several IVF clinics at a price range of $5,000 - $11,000 per cycle and from $4,500 to $7,000
at the existing INVO Centers, thereby making it more affordable than IVF (which tends to average $12,000 to $17,000 per cycle or higher).
Improved
efficiency providing for greater capacity and improved access to care and geographic availability. In many parts of the world, including
the U.S., IVF clinics tend to be concentrated in higher population centers and are often capacity constrained in terms of how many patients
a center can treat, since volume is limited by the number of capital-intensive incubators available in IVF clinic labs. With the significant
number of untreated patients along with the growing interest and demand for services, the industry remains challenged to provide sufficient
access to care and to do so at an economical price. We believe INVOcell and the IVC procedure it enables can play a significant role
in helping to address these challenges. According to the 2020 CDC Report, there are approximately 449 IVF centers in the U.S. We estimate
that by adopting the INVOcell, IVF clinics can increase fertility cycle volume by up to 30% without adding to personnel, space and/or
equipment costs. Our own INVO Centers also address capacity constraints by adding to the overall ART cycle capacity and doing so with
comparable efficacy to IVF outcomes as well as at a lower per cycle price. Moreover, we believe that we are uniquely positioned to drive
more significant growth in fertility treatment capacity in the future by partnering with existing OB/GYN practices. In the U.S., there
are an estimated 5,000 OB/GYN offices, many of which offer fertility services (usually limited to consultation and IUI, but not IVF).
Since the IVC procedure requires a much smaller lab facility, less equipment and fewer lab personnel (in comparison to conventional IVF),
it could potentially be offered as an extended service in an OB/GYN office. With proper training and a lighter lab infrastructure, the
INVOcell could expand the business for these physicians and allow them to treat patients that are unable to afford IVF and provide patients
with a more readily accessible, convenient, and cost-effective solution. With our three-pronged strategy (IVF clinics, INVO Centers and
OB/GYN practices), in addition to lowering costs, we believe INVOcell and the IVC procedure can address our industry’s key challenges,
capacity and cost, by their ability to expand and decentralize treatment and increase the number of points of care for patients in need.
This powerful combination of lower cost and added capacity has the potential to open up access to care for underserved patients around
the world.
Greater
patient involvement. With the IVC procedure, the patient uses their own body for fertilization, incubation, and early embryo development
which creates a greater sense of involvement, comfort, and participation. In some cases, this may also free people from barriers related
to due to ethical or religious concerns, or fears of laboratory mix-ups.
INVOcell
Sales and Marketing
Our
approach to market is focused on identifying partners within targeted geographic regions that we believe can best promote support our
efforts to expand access to advanced fertility treatment for the large number of underserved infertile people hoping to have a baby.
We believe that the INVOcell-based IVC procedure is an effective and affordable treatment option that greatly reduces the need for more
expensive IVF lab facilities and allows providers to pass on related savings to patients without compromising efficacy. We have been
cleared to sell the INVOcell in the United States since November 2015 after receiving de novo class II clearance from the FDA. Our primary
focus over the past two years has been on establishing INVO Centers in the U.S. and abroad to promote the INVOcell and the IVC procedure
and acquiring existing U.S.-based IVF clinics where we can integrate the INVOcell. While we continue selling the INVOcell directly to
IVF clinics and via distributors and other partners around the world, we have transitioned INVO from being a medical device company to
one that is mostly focused on providing fertility services.
International
Distribution Agreements
We
have entered into exclusive distribution agreements for a number of international markets. These agreements usually have an initial term
with renewal options and require the distributors to meet minimum annual purchases, which vary depending on the market. We are also required
to register the product in each market before the distributor can begin importing, a process and timeline that can vary widely depending
on the market.
The
following table sets forth a list of our current international distribution agreements:
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INVOcell
Registration |
Market |
|
Distribution
Partner |
|
Date |
|
Initial
Term |
|
Status
in Country |
|
|
|
|
|
|
|
|
|
Mexico
(a) |
|
Positib
Fertility, S.A. de C.V. |
|
Sept
2020 |
|
TBD** |
|
Completed |
Malaysia |
|
iDS
Medical Systems |
|
Nov
2020 |
|
3-year |
|
Completed |
Pakistan |
|
Galaxy
Pharma |
|
Dec
2020 |
|
1-year |
|
In
process |
Thailand |
|
IVF
Envimed Co., Ltd. |
|
April
2021 |
|
1-year |
|
Completed |
Sudan |
|
Quality
Medicines, Cosmetics & Medical Equipment Import |
|
Sept
2020 |
|
1-year |
|
In
process |
Ethiopia |
|
Quality
Medicines, Cosmetics & Medical Equipment Import |
|
Sept
2020 |
|
1-year |
|
In
process |
Uganda |
|
Quality
Medicines, Cosmetics & Medical Equipment Import |
|
Sept
2020 |
|
1-year |
|
Not
required |
Nigeria |
|
G-Systems
Limited |
|
Sept
2020 |
|
5-year |
|
Completed |
Iran |
|
Tasnim
Behboud |
|
Dec
2020 |
|
1-year |
|
Completed |
Sri
Lanka |
|
Alsonic
Limited |
|
July
2021 |
|
1-year |
|
In
process |
China |
|
Onesky
Holdings Limited |
|
May
2022 |
|
5-year |
|
In
process |
|
(a) |
Our
Mexico JV. Please note that the registration is temporarily in the name of Proveedora de Equipos y Productos, S.A. de C.V. and will
be transferred to Positib Fertility as soon as practicable. |
Investment
in Joint Ventures and Partnerships
As
part of our commercialization strategy, we entered into a number of joint ventures and partnerships designed to establish new INVO Centers.
The
following table sets forth a list of our current joint venture arrangements:
Affiliate Name | |
Country | |
Percent (%) Ownership | |
| |
| |
| |
HRCFG INVO, LLC | |
United States | |
| 50 | % |
Bloom Invo, LLC | |
United States | |
| 40 | % |
Positib Fertility, S.A. de C.V. | |
Mexico | |
| 33 | % |
Alabama
JV Agreement
On
March 10, 2021, our wholly owned subsidiary, INVO Centers, LLC (“INVO CTR”), entered into a limited liability company agreement
with HRCFG, LLC (“HRCFG”) to form a joint venture for the purpose of establishing an INVO Center in Birmingham, Alabama.
The name of the joint venture LLC is HRCFG INVO, LLC (the “Alabama JV”). The responsibilities of HRCFG’s principals
include providing clinical practice expertise, performing recruitment functions, providing all necessary training, and providing day-to-day
management of the clinic. The responsibilities of INVO CTR include providing certain funding to the Alabama JV and providing access to
and being the exclusive provider of the INVOcell to the Alabama JV. INVO CTR will also perform all required, industry specific compliance
and accreditation functions, and product documentation for product registration.
The
Alabama JV opened to patients on August 9, 2021.
The
Alabama JV is accounted for using the equity method in our financial statements. As of June 30, 2023 we invested $1.6 million in the
Alabama JV in the form of a note. For the six months ended June 30, 2023, the Alabama JV recorded net income of $2 thousand, of which
we recognized a gain from equity method investments of $805. For the six months ended June 30, 2022, the Alabama JV recorded a net loss
of $0.3 million, of which we recognized a loss from equity method investments of $0.2 million.
Georgia
JV Agreement
On
June 28, 2021, INVO CTR entered into a limited liability company agreement (the “Bloom Agreement”) with Bloom Fertility,
LLC (“Bloom”) to establish a joint venture entity, formed as “Bloom INVO LLC” (the “Georgia JV”),
for the purposes of commercializing INVOcell, and the related IVC procedure, through the establishment of an INVO Center, (the “Atlanta
Clinic”) in the Atlanta, Georgia metropolitan area.
In
consideration for INVO’s commitment to contribute up to $800,000 within the 24-month period following execution of the Bloom Agreement
to support the start-up operations of the Georgia JV, the Georgia JV issued 800 of its units to INVO CTR and in consideration for Bloom’s
commitment to contribute physician services having an anticipated value of up to $1,200,000 over the course of a 24-month vesting period,
the Georgia JV issued 1,200 of its units to Bloom.
The
responsibilities of Bloom include providing all medical services required for the operation of the Atlanta Clinic. The responsibilities
of INVO CTR include providing certain funding to the Georgia JV, lab services quality management, and providing access to and being the
exclusive provider of the INVOcell to the Georgia JV. INVO CTR will also perform all required, industry specific compliance and accreditation
functions, and product documentation for product registration.
The
Georgia JV opened to patients on September 7, 2021.
The
results of the Georgia JV are consolidated in our financial statements. As of June 30, 2023, INVO invested $0.9 million in the Georgia
JV in the form of capital contributions as well as $0.5 million in the form of a note. For the six months ended June 30, 2023 and 2022,
the Georgia JV recorded net losses of $0.1 million and $0.2 million respectively. Noncontrolling interest in the Georgia JV was $0. See
Note 3 of the Notes to Consolidated Financial Statements included in Item 1 of this Quarterly Report on Form 10-Q for additional information
on the Georgia JV.
Mexico
JV Agreement
Effective
September 24, 2020, INVO CTR entered into a Pre-Incorporation and Shareholders Agreement with Francisco Arredondo, MD PLLC (“Arredondo”)
and Security Health LLC, a Texas limited liability company (“Ramirez”, and together with INVO CTR and Arredondo, the “Shareholders”)
under which the Shareholders will commercialize the IVC procedure and offer related medical treatments in Mexico. Each party owns one-third
of the Mexican incorporated company, Positib Fertility, S.A. de C.V. (the “Mexico JV”).
The
Mexico JV will operate in Monterrey, Nuevo Leon, Mexico and any other cities and places in Mexico as approved by the Mexico JV’s
board of directors and Shareholders. In addition, the Shareholders agreed that the Mexico JV will be our exclusive distributor in Mexico.
The Shareholders also agreed not to compete directly or indirectly with the Mexico JV in Mexico.
The
Mexico JV opened to patients on November 1, 2021.
The
Mexico JV is accounted for using the equity method in our financial statements. As of June 30, 2023, INVO invested $0.1 million in the
Mexico JV. For the six months ended June 30, 2023 and 2022, the Mexico JV recorded net losses of $74 thousand and $90 thousand, respectively,
of which we recognized a loss from equity method investments of $24 thousand and $30 thousand, respectively.
Terminated
JV Agreements
As
of May 15, 2023, our JV agreements to establish INVO Centers in the Republic of North Macedonia and in the Bay Area of
California were terminated due to lack of progress.
Recent
Developments
Wisconsin
Fertility Institute Acquisition
On
August 10, 2023, INVO, through Wood Violet Fertility LLC, a Delaware limited liability company (“Buyer”) and wholly owned
subsidiary of INVO Centers LLC, a Delaware company wholly-owned by INVO, consummated its acquisition of the Wisconsin Fertility Institute
(the “Clinic”) for a combined purchase price of $10 million, of which $2.5 million was paid on the closing date (net $2,150,000
after a $350,000 holdback) plus assumption of the inter-company loan owed by WFRSA in the amount of $528,756 and the remaining three
installments of $2.5 million each will be paid on the subsequent three anniversaries of closing. The sellers have the option to take
all or a portion of the final three installments in shares of INVO common stock valued at $125.00, $181.80, and $285.80, for the second,
third, and final installments, respectively.
The
Clinic is comprised of (a) a medical practice, Wisconsin Fertility and Reproductive Surgery Associates, S.C., a Wisconsin professional
service corporation d/b/a Wisconsin Fertility Institute (“WFRSA”), and (b) a laboratory services company, Fertility Labs
of Wisconsin, LLC, a Wisconsin limited liability company (“FLOW”). WFRSA owns, operates and manages the Clinic’s fertility
practice that provides direct treatment to patients focused on fertility, gynecology and obstetrics care and surgical procedures, and
employs physicians and other healthcare providers to deliver such services and procedures. FLOW provides WFRSA with related laboratory
services.
INVO
is purchasing the non-medical assets of WFRSA and one hundred percent of FLOW’s membership interests. As reflected in the WFRSA
purchase agreement, the Buyer and WFRSA will enter into a management services agreement pursuant to which WFRSA will outsource all its
non-medical activities to the Buyer.
August
2023 Public Offering
On
August 4, 2023, we, entered into securities purchase agreements (the “Purchase Agreements”) with certain institutional and
other investors, pursuant to which we agreed to issue and sell to such investors in a public offering (the “Offering”), 1,580,000
units (the “Units”) with each Unit consisting of (i) one share (the “Shares”) of our Common Stock, and (ii) two
common stock purchase warrants (the “Warrants”), each exercisable for one share of Common Stock at an exercise price of $2.85
per share, for an aggregate of 1,580,000 Shares and Warrants to purchase 3,160,000 shares of Common Stock being sold in the Offering,
at a price of $2.85 per Unit. The securities to be issued in the Offering were offered pursuant to our registration statement on Form
S-1 (File 333-273174) (the “Registration Statement”), initially filed by us with the Securities and Exchange Commission (the
“SEC”) under the Securities Act of 1933, as amended (the “Securities Act”), on July 7, 2023 and declared effective
on August 3, 2023.
We
closed the Offering on August 8, 2023, raising gross proceeds of approximately $4 million before deducting placement agent fees and
other offering expenses payable by us. We used (i) $2,150,000 of the net proceeds to fund the initial installment of the purchase
price required to consummate our acquisition of the Wisconsin Fertility Institute (net of a $350,000 holdback) on August 10, 2023; (ii) $1,000,000 of
the net proceeds of this offering to pay Armistice the Armistice Amendment Fee for agreeing to remove the Subsequent Equity
Financing Provision from the Armistice SPA; (iii) $100,000 to repay that certain 8% Debenture with a maturity date of February 3, 2024 issued to Peak One Opportunity Fund
LP plus accrued interest and fees of approximately $7,784; and (iv) $39,849 to repay that certain 8% Debenture with a maturity date
of February 17, 2024 issued to First Fire Global Opportunities Fund, LLC, plus accrued interest and fees of approximately $3,127. We
intend to use the remaining net proceeds from this offering for working capital and general corporate purposes.
Also
in connection with the offering, on August 4, 2023, we entered into a placement agency agreement (the “Placement Agency Agreement”)
with Maxim Group LLC (the “Placement Agent”), pursuant to which (i) the Placement Agent agreed to act as placement agent
on a “best efforts” basis in connection with the Offering and (ii) we agreed to pay the Placement Agent an aggregate fee
equal to 7.0% of the gross proceeds raised in the offering and warrants to purchase up to 110,600 shares of Common Stock at an exercise
price of $3.14 (the “Placement Agent Warrants”). The Placement Agent Warrants (and the shares of Common Stock issuable upon
the exercise of the Placement Agent Warrants) were not registered under the Securities Act and were offered pursuant to an exemption
from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated
thereunder.
July
2023 Standard Merchant Cash Advance Agreement
On
July 19, 2023, we entered into a Standard Merchant Cash Advance Agreement with Cedar Advance LLC (“Cedar”) under which
Cedar purchased $543,750 of our receivables for a gross purchase price of $375,000. We received net proceeds of $356,250. Until the
purchase price has been repaid, we agreed to pay Cedar $19,419.64 per week. If we repay the purchase price within 30 days, then the
amount payable shall be reduced to $465,000. In addition, we granted Cedar a security interest in our accounts, including deposit
accounts and accounts receivable. We intend to use the proceeds for working capital and general corporate purposes.
Amendment
to Armistice SPA
On
July 7, 2023, we entered into an Amendment to Securities Purchase Agreement (the “Armistice Amendment”) with Armistice Capital
Markets Ltd. to delete Section 4.12(a) of our March 23, 2023 Securities Purchase Agreement (the “Armistice SPA”) with Armistice
pursuant to which we agreed that from March 23, 2023 until 45 days after the effective date of the Resale Registration Statement (as
defined below) we would not (i) issue, enter into any agreement to issue or announce the issuance or proposed issuance of any shares
of Common Stock or Common Stock Equivalents or (ii) file any registration statement or any amendment or supplement thereto, other than
the prospectus supplement filed in connection with that offering and the Resale Registration Statement (the “Subsequent Equity
Financing Provision”). In consideration of Armistice’s agreement to enter into the Armistice Amendment and delete the Subsequent
Equity Financing Provision from the Armistice SPA, we agreed to pay Armistice a fee a $1,000,000 (the “Armistice Amendment Fee”)
within two days of the closing of this Offering. Additionally, we agreed to include a proposal in our proxy statement for our 2023 Annual
Meeting of Stockholders for the purpose of obtaining the approval of the holders of a majority of our outstanding voting common stock,
to effectuate the reduction of the exercise price set forth in Section 2(b) of the Common Stock Purchase Warrants issued to Armistice
on March 27, 2023 (the “Existing Warrants”) to the per unit public offering price of this Offering, in accordance with Nasdaq
Rule 5635(d) (the “Shareholder Approval”) with the recommendation of our board of directors that such proposal be approved.
We also agreed to solicit proxies from our shareholders in connection therewith in the same manner as all other management proposals
in such proxy statement and that all management-appointed proxyholders shall vote their proxies in favor of such proposal. Further, if
we do not obtain Shareholder Approval at the first meeting, we will call a meeting every six (6) months thereafter to seek Shareholder
Approval until the earlier of the date Shareholder Approval is obtained or the Existing Warrants are no longer outstanding. Until such
approval is obtained, the exercise price of the Existing Warrants will remain unchanged.
Reverse
Stock Split
On
June 28, 2023, our board of directors approved a reverse stock split of our common stock at a ratio of 1-for-20 and also approved a
proportionate decrease in our authorized common stock to 6,250,000 shares from 125,000,000. Pursuant to Nevada Revised Statutes, a
company may effect a reverse split without stockholder approval if both the number of authorized shares of common stock and the
number of outstanding shares of common stock are proportionally reduced as a result of the reverse split, the reverse split does not
adversely affect any other class of stock of the company, and the company does not pay money or issue scrip to stockholders who
would otherwise be entitled to receive a fractional share as a result of the reverse split. On July 26, 2023, we filed a certificate of change with the Nevada Secretary
of State pursuant to Nevada Revised Statutes 78.209 to (i) decrease the number of authorized shares of common stock from 125,000,000 to
6,250,000 shares and (ii) effectuate a 1-for-20 reverse stock split of the outstanding common stock. On July 27, 2023, we received notice
from Nasdaq that the reverse split would take effect at the open of business on July 28, 2023 and the reverse stock split took effect
on that date.
510(k)
FDA Clearance
On
June 22, 2023, we received U.S. Food and Drug Administration (FDA) 510(k) clearance to expand the labeling on the INVOcell device and
its indication for use to provide for a 5-day incubation period. The data supporting the expanded 5-day incubation clearance demonstrated
improved patient outcomes.
March
2023 Registered Direct Offering
On
March 23, 2023, INVO entered into a securities purchase agreement (the “March Purchase Agreement”) with a certain institutional
investor, pursuant to which we agreed to issue and sell to such investor (i) in a registered direct offering (the “RD Offering”),
69,000 shares of Common Stock, and a pre-funded warrant (the “Pre-Funded Warrant”) to purchase up to 115,000 shares of Common
Stock, at an exercise price of $0.20 per share, and (ii) in a concurrent private placement (the “March Warrant Placement”),
a common stock purchase warrant (the “March Warrant”), exercisable for an aggregate of up to 276,000 shares of Common Stock,
at an exercise price of $12.60 per share. The securities to be issued in the RD Offering (priced at the marked under Nasdaq rules) were
offered pursuant to our shelf registration statement on Form S-3 (File 333-255096), initially filed by us with the SEC under the Securities
Act of 1933, as amended (the “Securities Act”), on April 7, 2021 and declared effective on April 16, 2021. The Pre-Funded
Warrant is exercisable upon issuance and will remain exercisable until all of the shares underlying the Pre-Funded Warrant are exercised
in full. All Pre-Funded Warrants were exercised by the investor in June 2023.
The
March Warrant (and the shares of Common Stock issuable upon the exercise of the Private Warrants) was not registered under the Securities
Act and was offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of
the Securities Act and Rule 506(b) promulgated thereunder. The March Warrant is immediately exercisable upon issuance, will expire eight
years from the date of issuance, and in certain circumstances may be exercised on a cashless basis.
On
March 27, 2023, we closed the RD Offering and March Warrant Placement, raising gross proceeds of approximately $3 million before deducting
placement agent fees and other offering expenses payable by us. In the event the March Warrant is fully exercised for cash, we would
receive additional gross proceeds of approximately $3.5 million. We used $383,879 in proceeds to repay a portion of the convertible debenture
issued in February 2023 and the remainder of the proceeds are being used for working capital and general corporate purposes.
Under
the March Purchase Agreement, We are required within 30 days of the closing date of the March Warrant Placement to file a registration
statement on Form S-1 (the “Resale Registration Statement”) registering the resale of the shares of Common Stock issuable
upon the exercise of the March Warrant. We are required to use commercially reasonable efforts to cause such registration to become effective
within 75 days of the closing date of the offering (or 120 days if the registration statement is subject to a full review by the SEC),
and to keep the Resale Registration Statement effective at all times until no shares of Common Stock remain exercisable under the March
Warrant.
In
addition, pursuant to certain “lock-up” agreements, our officers and directors have agreed, for a period of 180 days from
the date of the RD Offering and March Warrant Placement, not to engage in any of the following, whether directly or indirectly, without
the consent of the March Purchase Agreement investor: offer to sell, sell, contract to sell pledge, grant, lend, or otherwise transfer
or dispose of our common stock or any securities convertible into or exercisable or exchangeable for Common Stock (the “Lock-Up
Securities”); enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences
of ownership of the Lock-Up Securities; make any demand for or exercise any right or cause to be filed a registration statement, including
any amendments thereto, with respect to the registration of any Lock-Up Securities; enter into any transaction, swap, hedge, or other
arrangement relating to any Lock-Up Securities subject to customary exceptions; or publicly disclose the intention to do any of the foregoing.
Notices
from Nasdaq of Failure to Satisfy Continued Listing Rules
Notice
Regarding Non-Compliance with Minimum Stockholders’ Equity
On
November 23, 2022, we received notice from The Nasdaq Stock Market LLC (“Nasdaq”) advising us that we were not in compliance
with the minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(b)(1)
(the “Equity Rule”) requires companies listed on The Nasdaq Capital Market to maintain stockholders’ equity of at least
$2,500,000 (the “Stockholders’ Equity Requirement”). In our Quarterly Report on Form 10-Q for the quarter ended September
30, 2022, we reported stockholders’ equity of $1,287,224, which is below the Stockholders’ Equity Requirement for continued
listing. Additionally, as of the date of the notice, we did not meet either of the alternative Nasdaq continued listing standards under
the Nasdaq Listing Rules, market value of listed securities of at least $35 million, or net income of $500,000 from continuing operations
in the most recently completed fiscal year, or in two of the three most recently completed fiscal years.
The
notice had no immediate effect on the listing of our common stock and our common stock continues to trade on The Nasdaq Capital Market
under the symbol “INVO” subject to our compliance with the other continued listing requirements.
Pursuant
to the notice, Nasdaq gave us 45 calendar days, or until January 7, 2023, to submit to Nasdaq a plan to regain compliance. We submitted
our plan within the prescribed time and, on January 18, 2023, we received a letter from Nasdaq stating that based on our submission that
Nasdaq had determined to grant us an extension of time to regain compliance with the Equity Rule until May 22, 2023.
On
May 23, 2023, we were notified by the Listing Qualifications department (the “Staff”) of Nasdaq that, based upon our non-compliance
with the $2.5 million stockholders’ equity requirement for continued listing on The Nasdaq Global Market, as set forth in the Equity
Rule, as of May 22, 2023, our common stock was subject to delisting from Nasdaq unless we timely requested a hearing before the Nasdaq
Hearings Panel (the “Panel”).
We
requested a hearing before the Panel, which stayed any further action by Nasdaq at least until the hearing process was concluded and
any extension that may be granted by the Panel has expired.
On
July 6, 2023, we had our hearing before the Panel at which time we provided the Panel our plan to regain compliance under the Equity
Rule.
On
July 27, 2023, we received a letter from the Panel under which they granted our request for continued listing of Nasdaq subject to us
demonstrating compliance with the Equity Rule as well as Nasdaq Listing Rule 5550(a)(2) (to maintain a minimum bid price of $1; the “Price
Rule”) on or before September 29. 2023. The Panel reserves the right to reconsider the terms of this exception based on any event,
condition or circumstance that exists or develops that would, in the opinion of the Panel, make continued listing of our securities on
Nasdaq inadvisable or unwarranted. In that regard, the Panel advises us that it is a requirement during the exception period we provide
prompt notification of any significant events that occur during this time that may affect our compliance with Nasdaq requirements. This
includes, but is not limited to, prompt advance notice of any event that may call into question our ability to meet the terms of the
exception granted.
Notice
Regarding Failure to Maintain Minimum Bid Price
On
January 11, 2023, we received a letter from the staff indicating that, based upon the closing bid price of our common stock for the last
30 consecutive business days, we were not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued
listing under the Price Rule.
The
notice had no immediate effect on the listing of our common stock, and our common stock continues to trade on The Nasdaq Capital Market
under the symbol “INVO.”
In
accordance with Nasdaq Listing Rule 5810(c)(3)(A), we were provided an initial period of 180 calendar days, or until July 10, 2023, to
regain compliance with the minimum bid price requirement. If at any time before July 10, 2023, the closing bid price of our common stock
closed at or above $1.00 per share for a minimum of 10 consecutive business days, Nasdaq would provide written notification that we have
achieved compliance with the minimum bid price requirement, and the matter would be resolved. If we did not regain compliance prior to
July 10, 2023, then Nasdaq may grant us a second 180 calendar day period to regain compliance, provided we (i) meet the continued listing
requirement for market value of publicly-held shares and all other initial listing standards for The Nasdaq Capital Market, other than
the minimum closing bid price requirement, and (ii) notify Nasdaq of its intent to cure the deficiency within such second 180 calendar
day period, by effecting a reverse stock split, if necessary.
We
were unable to regain compliance by July 10, 2023 and accordingly on July 11, 2023, we received a notice from Staff of Nasdaq that, based
upon our non-compliance with the minimum bid price requirement set forth in the Price Rule. We presented our plan to regain compliance
with the minimum bid price requirement at our hearing with the Panel on July 6, 2023.
On
July 27, 2023, we received a letter from the Panel under which they granted our request for continued listing of Nasdaq subject to us
demonstrating compliance with the Equity Rule and the Price Rule on or before September 29. 2023. The Panel reserves the right to reconsider
the terms of this exception based on any event, condition or circumstance that exists or develops that would, in the opinion of the Panel,
make continued listing of our securities on Nasdaq inadvisable or unwarranted. In that regard, the Panel advises us that it is a requirement
during the exception period we provide prompt notification of any significant events that occur during this time that may affect our
compliance with Nasdaq requirements. This includes, but is not limited to, prompt advance notice of any event that may call into question
our ability to meet the terms of the exception granted.
Results
of Operations
During the first half of 2023, we made further progress
toward our key objectives. Our three existing operational INVO Centers experienced growing revenues and improved operating results. Progress
also continued toward opening our planned new Tampa INVO Center, which we expect to open in the second half of this year. At the end of
the second quarter, we received FDA clearance on our 510k submission, which represented a very significant milestone resulting from our
multi-year effort to advance the INVOcell technology and further demonstrate its success and quality of outcomes.
Subsequent to the second quarter end, we completed
a major step forward on our previously announced acquisition strategy. On August 10, 2023 we closed our first acquisition, Wisconsin Fertility
Institute (“WFI”). The acquisition of WFI is expected to provide significant scale to our operations and complement our INVO
Center strategy. The Madison-based fertility center primarily offers conventional IVF procedures and generated more than $5 million in
revenue and approximately $1.7 million of net income based on fiscal 2022 audited results.
Looking
ahead, we will continue to seek out and pursue accretive acquisition opportunities along with our plans to open additional INVO Centers
in key domestic markets. With respect to INVO Centers, we have selected an initial list of markets in the U.S. that we believe are excellent
potential locations, and we believe the universe of suitable acquisition targets for INVO exceeds 80 clinics in the U.S. We also continue
to work on the expansion of INVOcell distribution into existing fertility clinics.
From
a market strategy perspective, our commercialization efforts will continue to focus on the substantial, underserved patient population
and on expanding access to advanced fertility treatments. We believe our solutions can help address the key challenges of affordability
and capacity to provide care to the vast number of patients that go untreated every year. This represents the major opportunity for INVOcell
and the IVC procedure it enables. Despite the COVID pandemic, the fertility industry continues to expand, and we believe our growing
volume of partners (both distributors and joint venture INVO Centers) affords us strong forward-looking opportunities. We believe our INVO Center
approach and our plans to implement IVC procedures in acquired clinics can help to add much needed capacity and affordability and aligns
with our key mission to open access to care to the underserved patient population.
The
ART market also continues to benefit from a number of industry tailwinds, including 1) the large under-served potential patient population,
2) increasing infertility rates around the world 3) growing awareness and education of fertility treatment options, 4) a growing acceptance
of fertility treatment, 5) improvements in procedure techniques and hence improvements in pregnancy success rates and 6) generally improving
insurance (private and public) reimbursement trends.
Comparison
of the Three Months Ended June 30, 2023, and 2022
Revenue
Revenue
for the three months ended June 30, 2023, was approximately $316 thousand compared to approximately $146 thousand for the three months
ended June 30, 2022. Of the $316 thousand in revenue for the second quarter of 2023, approximately $254 thousand was related to clinic
revenue from the consolidated Georgia JV. The increase of approximately $170 thousand, or approximately 116%, was primarily related to
increased revenue from the Georgia JV.
Cost of Revenue
Cost of revenue for the three months ended June 30,
2023, was approximately $235 thousand compared to approximately $171 thousand for the three months ended June 30, 2022.
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses for the three months ended June 30, 2023, were approximately $2.0 million compared to approximately
$2.4 million for the three months ended June 30, 2022. The decrease of approximately $0.4 million, or approximately 16%, was primarily
the result of approximately $0.2 million in decreased personnel expenses and approximately $0.2 million in decreased marketing expenses.
Non-cash, stock-based compensation expense, which was $0.4 million in the period, compared to $0.7 million for the same period in the
prior year.
Research
and Development Expenses
We
began to fund additional research and development (“R&D”) efforts in 2020 as part of our 5-day label expansion efforts.
R&D expenses were approximately $84 thousand and $0.2 million for the three months ended June 30, 2023, and March 31, 2022, respectively.
Gain
(loss) from equity investment
Gain
from equity investments for the three months ended June 30, 2023, was approximately $4 thousand compared to a $0.1 million loss for
the three months ended June 30, 2022. The gain is due to an increase in revenue from the equity method JV’s and a decrease in
expenses associated with one-time startup costs.
Interest
Expense and Financing Fees
Interest
expense and financing fees were approximately $175 thousand for the three months ended June 30, 2023, compared to approximately $102
for the three months ended June 30, 2022. The expense in 2023 was primarily non-cash and due to the debt discount, debt issuance cost
and interest from convertible notes.
Comparison
of the Six Months Ended June 30, 2023, and 2022
Revenue
Revenue
for the six months ended June 30, 2023, was approximately $0.7 million compared to approximately $0.3 million for the six months ended
June 30, 2022. Of the $0.7 million in revenue for the six months ended June 30, 2023, $0.6 was related to clinic revenue from the consolidated
Georgia JV. The increase of approximately $0.4 million, or approximately 155%, was primarily related to increased revenue from the Georgia
JV.
Cost of Revenue
Cost of revenue for the six months ended June 30,
2023, was approximately $0.5 million compared to approximately $0.4 million for the six months ended June 30, 2022.
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses for the six months ended June 30, 2023, were approximately $4.4 million compared to approximately
$5.0 million for the six months ended June 30, 2022. The decrease of approximately $0.6 million, or approximately 12%, was primarily
the result of approximately $0.5 million in decrease expenses related to personnel expenses, approximately $0.4 million in decreased
marketing expenses, and was partially offset by a $0.2 million increase in professional fees related to the acquistion of WFI and $0.1
million increase in operational expenses related to the Georgia JV. Non-cash, stock-based compensation expense, which was $0.3 million
in the period, compared to $0.5 million for the same period in the prior year.
Research
and Development Expenses
R&D
expenses were approximately $0.2 million and $0.3 million for the six months ended June 30, 2023, and June 30, 2022, respectively.
Loss
from equity investment
Loss
from equity investments for the six months ended June 30, 2023, was approximately $24 thousand compared to $0.2 million for the six
months ended June 30, 2022. The decrease in loss is due to an increase in revenue in the equity method JV’s and a decrease in
expenses associated with one-time startup costs.
Interest
Expense and Financing Fees
Interest
expense and financing fees were approximately $0.4 million for the six months ended June 30, 2023, compared to approximately $2 thousand
for the six months ended June 30, 2022. The expense in 2023 was primarily non-cash and due to the debt discount, debt issuance cost and
interest from convertible notes.
Liquidity
and Capital Resources
For
the six months ended June 30, 2023, and 2022, we had net losses of approximately $4.8 million and $5.6 million, respectively, and an
accumulated deficit of approximately $54.6 million as of June 30, 2023. Approximately $1.4 million of the net loss was related to non-cash
expenses for the six months ended June 30, 2023, compared to $1.6 million for the six months ended June 30, 2022. We had negative working
capital of approximately $3.6 million as of June 30, 2023, compared to negative working capital of approximately $2.8 million as of December
31, 2022. As of June 30, 2023, we had stockholder’s deficit of approximately $1.7 million compared to stockholder’s deficit
of approximately $1.0 million as of December 31, 2022.
We
have been dependent on raising capital from debt and equity financings to meet our needs for cash required to fund our operating expenses
and investing activities. During the first six months of 2023, we received proceeds of approximately $2.7 million for the sale of our
Common Stock and $0.7 million in proceeds from the sale of convertible notes. During the first six months of 2022, we received approximately
$0.3 million for the sale of Common Stock. Over the next 12 months, our plan includes opening additional INVO Centers, completing the
acquisition of Wisconsin Fertility Institute and pursuing additional IVF clinic acquisitions. Until we can generate positive cash from
operations, we will need to raise additional funding to meet our liquidity needs and to execute our business strategy. As in the past,
we will seek debt and/or equity financing, which may not be available on reasonable terms, if at all.
Although
our audited financial statements for the year ended December 31, 2022 were prepared under the assumption that we would continue operations
as a going concern, the report of our independent registered public accounting firm that accompanies our financial statements for the
year ended December 31, 2022 contains a going concern qualification in which such firm expressed substantial doubt about our ability
to continue as a going concern, based on the financial statements at that time. Specifically, as noted above, we have incurred significant
operating losses and we expect to continue to incur significant expenses and operating losses as we continue to ramp up the commercialization
of INVOcell and develop new INVO Centers. These prior losses and expected future losses have had, and will continue to have, an adverse
effect on our financial condition. If we cannot continue as a going concern, our stockholders would likely lose most or all of their
investment in us.
Cash
Flows
The
following table shows a summary of our cash flows for the six months ended June 30, 2023 and 2022:
|
|
2023 |
|
|
2022 |
|
Cash
(used in) provided by: |
|
|
|
|
|
|
|
|
Operating
activities |
|
|
(2,792,860 |
) |
|
|
(3,950,920 |
) |
Investing
activities |
|
|
(269,952 |
) |
|
|
(86,792 |
) |
Financing
activities |
|
|
3,085,162 |
|
|
|
315,000 |
|
Cash
Flows from Operating Activities
As
of June 30, 2023, we had approximately $0.1 million in cash compared to approximately $2.0 million as of June 30, 2022. Net cash used
in operating activities for the first six months of 2023 was approximately $2.8 million, compared to approximately $4.0 million for the
same period in 2022. The decrease in net cash used in operating activities was primarily due to the increase in accounts payable and
accrued compensation.
Cash
Flows from Investing Activities
During
the six months ended June 30, 2023, cash used in investing activities of $0.3 million was primarily related to the buildout infrastructure
for our Tampa INVO Center. During the six months ended June 30, 2022, cash used in investing activities of approximately $0.1 million
was primarily related to a loss on equity method for the JVs, payments to acquire property, plant, and equipment, as well as investment
in trademarks.
Cash
Flows from Financing Activities
During
the six months ended June 30, 2023 cash provided by financing activities of approximately $3.0 million was primarily related to the sale
of Common Stock and convertible notes. During the six months ended June 30, 2022, cash provided by financing activities of approximately
$0.3 million primarily related to the sale of Common Stock, net of offering costs.
Critical
Accounting Policies and Estimates
The
discussion and analysis of our financial condition presented in this section is based upon our audited consolidated financial statements,
which have been prepared in accordance with generally accepted accounting principles in the United States. During the preparation of
the financial statements, we are required to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue
and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate, based on historical experience
and on various other assumptions that are believed to be reasonable under the circumstances, our results, which allows us to form a basis
for making judgments on the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results
may differ from these estimates based on variance with our assumptions and conditions. A summary of significant accounting policies is
included below. Management believes that the application of these policies on a consistent basis enables us to provide useful and reliable
financial information about our operating results and financial condition.
See
Note 1 of the Notes to Consolidated Financial Statements included in Item 1 of this Quarterly Report on Form 10-Q for a summary of significant
accounting policies and the effect on our financial statements.
Stock
Based Compensation
We
account for stock-based compensation under the provisions of ASC 718-10 Share-Based Payment (formerly SFAS 123R). This statement
requires us to measure the cost of employee services received in exchange for an award of equity instruments based on the grant-date
fair value of the award. That cost is recognized over the period in which the employee is required to provide service or performance
goals in exchange for the award, which is usually immediate but sometimes over a vesting period. Warrants granted to non-employees are
recorded as an expense over the requisite service period based on the grant date and the estimated fair value of the grant, which is
determined using the Black-Scholes option pricing model.
Revenue
Recognition
We
recognize revenue on arrangements in accordance with ASC 606, Revenue from Contracts with Customers. The core principle of ASC 606 is
to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which
an entity expects to be entitled for those goods or services ASC 606 requires companies to assess their contracts to determine the timing
and amount of revenue to recognize under the new revenue standard. The model has a five-step approach:
1. |
Identify
the contract with the customer. |
|
|
2. |
Identify
the performance obligations in the contract. |
|
|
3. |
Determine
the total transaction price. |
|
|
4. |
Allocate
the total transaction price to each performance obligation in the contract. |
|
|
5. |
Recognize
as revenue when (or as) each performance obligation is satisfied. |
Variable
Interest Entities
Our
consolidated financial statements include the accounts of INVO, its wholly owned subsidiaries and variable interest entities (“VIE”),
where we are the primary beneficiary under the provisions of ASC 810, Consolidation (“ASC 810”). A VIE must be consolidated
by its primary beneficiary when, along with its affiliates and agents, the primary beneficiary has both: (i) the power to direct the
activities that most significantly impact the VIE’s economic performance; and (ii) the obligation to absorb losses or the right
to receive the benefits of the VIE that could potentially be significant to the VIE. We reconsider whether an entity is still a VIE only
upon certain triggering events and continually assesses its consolidated VIEs to determine if it continues to be the primary beneficiary.
Equity
Method Investments
Investments
in unconsolidated affiliates in which we exert significant influence but do not control or otherwise consolidate are accounted for using
the equity method. Equity method investments are initially recorded at cost. These investments are included in investment in joint ventures
in the accompanying consolidated balance sheets. Our share of the profits and losses from these investments is reported in loss from
equity method investment in the accompanying consolidated statements of operations. Management monitors its investments for other-than-temporary
impairment by considering factors such as current economic and market conditions and the operating performance of the investees and records
reductions in carrying values when necessary.
Recently
Issued Accounting Standards Not Yet Effective or Adopted
Management
does not believe that any recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact
on the accompanying condensed consolidated financial statements.
Item
3. Quantitative and Qualitative Disclosures about Market Risks
We
are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required
under this item.
We
are exposed to risk from changes in foreign currency exchange rates related to our foreign joint venture. Our principal exchange rate
exposure relates to the Mexican Peso.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”), that are designed to be effective in providing reasonable assurance that information required to be
disclosed in our reports under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in
the rules and forms of the Securities and Exchange Commission (“SEC”), and that such information is accumulated and communicated
to our management to allow timely decisions regarding required disclosure.
Our
management, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, carried out
an evaluation of the effectiveness of the design and operation of the our disclosure controls and procedures (as defined
in Rule 13a-15(e) and 15d-15(e) of the Exchange Act) as of June 30, 2023, the end of the fiscal period covered by this Form 10-Q. Based
upon that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures
were effective as of June 30, 2023.
Changes
in Internal Control over Financial Reporting
There
were no changes to our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act)
that occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings
None.
Item
1A. Risk Factors
Risk
factors that affect our business and financial results are discussed in Part I, Item 1A “Risk Factors,” in our Annual Report
on Form 10-K for the year ended December 31, 2022 (“Annual Report”) as filed with the SEC on April 17, 2023, as amended.
There have been no material changes in our risk factors from those previously disclosed in our Annual Report. You should carefully consider
the risks described in our Annual Report, which could materially affect our business, financial condition or future results. The risks
described in our Annual Report are not the only risks we face. Additional risks and uncertainties not currently known to us or that we
currently deem to be immaterial also may materially adversely affect our business, financial condition, and/or operating results. If
any of the risks actually occur, our business, financial condition, and/or results of operations could be negatively affected.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
On May 18, 2023, the Company issued 6,115 shares of
Common Stock to consultants in consideration of services rendered with a fair value of $45,000. These shares were issued pursuant to the
exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. The Company did not receive any cash
proceeds from this issuance.
On July 11, 2023, the Company issued 16,250 shares
of Common Stock in consideration of a settlement with an unrelated third party. These shares were issued pursuant to the exemption from
registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. The Company did not receive any cash proceeds from
this issuance.
In July 2023, the Company issued 135 shares of our
common stock as the result of the rounding up of fractional shares resulting from the 1-20 reverse stock split of the Company’s
common stock effectuated on July 28, 2023. The Company did not receive any proceeds from the issuance. The issuance was exempt under Section
3(a)(9) of the Securities Act of 1933, as amended.
On August 8, 2023, the Company issued 26,391 shares of Common Stock upon
exercise of an existing warrant on a net-exercise basis. These shares were issued pursuant to the exemption from registration provided
by Section 4(a)(2) and/or 3(a)(9) of the Securities Act of 1933, as amended.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
applicable
Item
5. Other Information
Temporary
Reduction of Salary under Employment Agreements
On
August 10, 2023 the Company’s CEO, Steven Shum, voluntarily agreed to temporarily reduce the annual base salary under his employment
agreement from $260,000 to $105,000 until further notice, which reduction will take effect on August 16, 2023 (the “Shum Temporary Salary Reduction”).
The foregoing description of the Shum Temporary Salary Reduction is qualified
in its entirety by reference to a copy of the Shum Temporary Salary Reduction letter filed as Exhibit 10.1 to this Quarterly Report on
Form 10-Q and incorporated herein by reference.
On
August 10, 2023 the Company’s CFO, Andrea Goren, voluntarily agreed to temporarily reduce the annual base salary under his employment
agreement from $215,000 to $105,000 until further notice, which reduction will take effect on August 16, 2023 (the “Goren Temporary Salary Reduction”).
The foregoing description of the Goren Temporary Salary
Reduction is qualified in its entirety by reference to a copy of the Goren Temporary Salary Reduction letter filed as Exhibit 10.2 to
this Quarterly Report on Form 10-Q and incorporated herein by reference.
Item
6. Exhibits
|
|
*
Filed herewith. |
|
|
**
Furnished herewith. |
SIGNATURES
Pursuant to the requirements of
the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized on August 14, 2023.
|
INVO Bioscience, Inc. |
|
|
|
Date: August 14, 2023 |
By: |
/s/ Steven Shum |
|
|
Steven Shum, Chief Executive Officer |
|
|
(Principal Executive Officer) |
|
|
|
Date: August 14, 2023 |
By: |
/s/ Andrea Goren |
|
|
Andrea Goren, Chief Financial Officer |
|
|
(Principal Financial and Accounting Officer) |
Exhibit
10.1
August
10, 2023
INVO
Bioscience, Inc.
5582
Broadcast Ct.
Sarasota,
FL 34240
Ladies
and Gentlemen:
Please
be advised that effective August 16 2023, I hereby voluntarily agree to temporarily reduce the Annual Base Salary under my Employment
Agreement dated October 16, 2019 from $260,000 to $105,000 until further notice.
|
Regards, |
|
|
|
/s/
Steve Shum |
|
Steve
Shum |
ACCEPTED
AND AGREED: |
|
|
|
|
INVO
Bioscience, Inc. |
|
|
|
|
By: |
/s/
Andrea Goren |
|
|
Andrea
Goren, CFO |
|
Exhibit
10.2
August
10, 2023
INVO
Bioscience, Inc.
5582
Broadcast Ct.
Sarasota,
FL 34240
Ladies
and Gentlemen:
Please
be advised that effective August 16 2023, I hereby voluntarily agree to temporarily reduce the Annual Base Salary under my Amended and
Restated Employment Agreement from $215,000 to $105,000 until further notice.
|
Regards, |
|
|
|
/s/
Andrea Goren |
|
Andrea
Goren |
ACCEPTED
AND AGREED: |
|
|
|
|
INVO
Bioscience, Inc. |
|
|
|
|
By: |
/s/
Steve Shum |
|
|
Steve
Shum, CEO |
|
Exhibit
31.1
Certification
of Principal Executive Officer of INVO Bioscience, Inc.
Pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002
I,
Steven Shum, certify that:
1. |
I
have reviewed this quarterly report on Form 10-Q of INVO Bioscience Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the unaudited condensed consolidated financial statements, and other financial information included in this report,
fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and
for, the periods presented in this report; |
|
|
4. |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed
under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles; |
|
|
|
c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such
evaluation; and |
|
|
|
d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that
has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;
and |
5. |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
|
a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which
are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
|
INVO
BIOSCIENCE |
|
|
|
Date:
August 14, 2023 |
By: |
/s/
Steven Shum |
|
|
Steven
Shum |
|
|
Principal
Executive Officer |
Exhibit
31.2
Certification
of Principal Financial Officer of INVO Bioscience, Inc.
Pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002
I,
Andrea Goren, certify that:
1. |
I
have reviewed this quarterly report on Form 10-Q of INVO Bioscience Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the unaudited condensed consolidated financial statements, and other financial information included in this report,
fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and
for, the periods presented in this report; |
|
|
4. |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed
under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles; |
|
|
|
c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such
evaluation; and |
|
|
|
d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that
has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;
and |
5. |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
|
a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which
are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
|
INVO
BIOSCIENCE |
|
|
|
Date:
August 14, 2023 |
By: |
/s/
Andrea Goren |
|
|
Andrea
Goren |
|
|
Chief
Financial Officer
(Principal
Financial and Accounting Officer) |
Exhibit
32.1
Certification
of Principal Executive Officer and Principal Financial Officer
Pursuant
to 18 U.S.C. Section 1350 as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
In
connection with the Quarterly Report on Form 10-Q of INVO Bioscience, Inc. (the “Company”) for the period ended June 30,
2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, Steven Shum,
Chief Executive Officer of the Company, and Andrea Goren, Chief Financial Officer of the Company, each hereby certifies, pursuant to
18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
|
INVO
BIOSCIENCE |
|
|
|
Date:
August 14, 2023 |
By: |
/s/
Steven Shum |
|
|
Steven
Shum |
|
|
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
|
INVO
BIOSCIENCE |
|
|
|
Date:
August 14, 2023 |
By: |
/s/
Andrea Goren |
|
|
Andrea
Goren |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial and Accounting Officer) |
v3.23.2
Cover - shares
|
6 Months Ended |
|
Jun. 30, 2023 |
Aug. 14, 2023 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Jun. 30, 2023
|
|
Document Fiscal Period Focus |
Q2
|
|
Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-39701
|
|
Entity Registrant Name |
INVO
Bioscience, Inc.
|
|
Entity Central Index Key |
0001417926
|
|
Entity Tax Identification Number |
20-4036208
|
|
Entity Incorporation, State or Country Code |
NV
|
|
Entity Address, Address Line One |
5582 Broadcast
Court
|
|
Entity Address, City or Town |
Sarasota
|
|
Entity Address, State or Province |
FL
|
|
Entity Address, Postal Zip Code |
34240
|
|
City Area Code |
(978)
|
|
Local Phone Number |
878-9505
|
|
Title of 12(b) Security |
Common Stock, $0.0001
par value per share
|
|
Trading Symbol |
INVO
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
false
|
|
Entity Shell Company |
false
|
|
Entity Common Stock, Shares Outstanding |
|
2,449,662
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v3.23.2
Consolidated Balance Sheets (Unaudited) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Current assets |
|
|
Cash |
$ 112,485
|
$ 90,135
|
Accounts receivable |
74,908
|
77,149
|
Inventory |
280,018
|
263,602
|
Prepaid expenses and other current assets |
374,714
|
190,201
|
Total current assets |
842,125
|
621,087
|
Property and equipment, net |
659,442
|
436,729
|
Lease right of use |
4,004,962
|
1,808,034
|
Investment in joint ventures |
1,132,365
|
1,237,865
|
Total assets |
6,638,894
|
4,103,715
|
Current liabilities |
|
|
Accounts payable and accrued liabilities |
1,844,629
|
1,349,038
|
Accrued compensation |
1,202,420
|
946,262
|
Deferred revenue |
161,187
|
119,876
|
Lease liability, current portion |
227,026
|
231,604
|
Total current liabilities |
4,469,150
|
3,409,424
|
Lease liability, net of current portion |
3,873,289
|
1,669,954
|
Deferred tax liability |
1,949
|
1,949
|
Total liabilities |
8,344,388
|
5,081,327
|
Stockholders’ deficit |
|
|
Common Stock, $.0001 par value; 6,250,000 shares authorized; 826,886 and 608,611 issued and outstanding as of June 30, 2023 and December 31, 2022, respectively |
83
|
61
|
Additional paid-in capital |
52,869,346
|
48,805,860
|
Accumulated deficit |
(54,574,923)
|
(49,783,533)
|
Total stockholders’ deficit |
(1,705,494)
|
(977,612)
|
Total liabilities and stockholders’ deficit |
6,638,894
|
4,103,715
|
Nonrelated Party [Member] |
|
|
Current liabilities |
|
|
Notes payable, net |
263,888
|
100,000
|
Related Party [Member] |
|
|
Current liabilities |
|
|
Notes payable, net |
$ 770,000
|
$ 662,644
|
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v3.23.2
Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
6,250,000
|
6,250,000
|
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826,886
|
608,611
|
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|
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v3.23.2
Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Revenue: |
|
|
|
|
Total revenue |
$ 315,902
|
$ 146,135
|
$ 663,927
|
$ 308,733
|
Operating expenses |
|
|
|
|
Cost of revenue |
235,714
|
170,526
|
466,719
|
367,207
|
Selling, general and administrative expenses |
2,042,609
|
2,444,586
|
4,373,443
|
4,991,714
|
Research and development expenses |
83,850
|
190,761
|
157,370
|
294,941
|
Depreciation and amortization |
19,705
|
22,083
|
38,792
|
37,630
|
Total operating expenses |
2,381,879
|
2,827,956
|
5,036,324
|
5,691,492
|
Loss from operations |
(2,065,977)
|
(2,681,821)
|
(4,372,397)
|
(5,382,759)
|
Other income (expense): |
|
|
|
|
Income (loss) from equity method joint ventures |
3,788
|
(117,978)
|
(23,947)
|
(189,095)
|
Interest income |
|
48
|
|
273
|
Interest expense |
(175,192)
|
(102)
|
(391,781)
|
(1,558)
|
Foreign currency exchange loss |
(265)
|
(888)
|
(400)
|
(1,914)
|
Total other income (expense) |
(171,669)
|
(118,920)
|
(416,128)
|
(192,294)
|
Net loss before income taxes |
(2,237,646)
|
(2,800,741)
|
(4,788,525)
|
(5,575,053)
|
Income taxes |
2,865
|
800
|
2,865
|
800
|
Net loss |
$ (2,240,511)
|
$ (2,801,541)
|
$ (4,791,390)
|
$ (5,575,853)
|
Net loss per common share: |
|
|
|
|
Basic |
$ (3.06)
|
$ (4.62)
|
$ (7.07)
|
$ (9.23)
|
Diluted |
$ (3.06)
|
$ (4.62)
|
$ (7.07)
|
$ (9.23)
|
Weighted average number of common shares outstanding: |
|
|
|
|
Basic |
732,255
|
605,760
|
677,684
|
604,123
|
Diluted |
732,255
|
605,760
|
677,684
|
604,123
|
Clinic Revenue [Member] |
|
|
|
|
Revenue: |
|
|
|
|
Total revenue |
$ 254,364
|
$ 112,358
|
$ 551,745
|
$ 218,206
|
Product [Member] |
|
|
|
|
Revenue: |
|
|
|
|
Total revenue |
$ 61,538
|
$ 33,777
|
$ 112,182
|
$ 90,527
|
X |
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v3.23.2
Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balances, value at Dec. 31, 2021 |
$ 60
|
$ 46,200,509
|
$ (38,891,022)
|
$ 7,310,680
|
Balance, shares at Dec. 31, 2021 |
596,457
|
|
|
|
Common stock issued to directors and employees |
|
328,548
|
|
328,548
|
Common stock issued to directors and employees, shares |
2,576
|
|
|
|
Common stock issued for services |
|
116,766
|
|
116,766
|
Common stock issued for services, shares |
2,750
|
|
|
|
Proceeds from the sale of common stock, net of fees and expenses |
|
315,000
|
|
315,000
|
Proceeds from the sale of common stock, net of fees and expenses, shares |
4,731
|
|
|
|
Stock options issued to directors and employees as compensation |
|
861,284
|
|
861,284
|
Net loss |
|
|
(5,575,853)
|
(5,575,853)
|
Balances, value at Jun. 30, 2022 |
$ 60
|
47,823,860
|
(44,466,875)
|
3,356,425
|
Balance, shares at Jun. 30, 2022 |
606,514
|
|
|
|
Balances, value at Dec. 31, 2022 |
$ 61
|
48,805,860
|
(49,783,533)
|
(977,612)
|
Balance, shares at Dec. 31, 2022 |
608,611
|
|
|
|
Common stock issued to directors and employees |
|
51,565
|
|
51,565
|
Common stock issued to directors and employees, shares |
3,994
|
|
|
|
Common stock issued for services |
$ 3
|
244,173
|
|
244,176
|
Common stock issued for services, shares |
25,817
|
|
|
|
Proceeds from the sale of common stock, net of fees and expenses |
$ 18
|
2,728,920
|
|
2,728,938
|
Proceeds from the sale of common stock, net of fees and expenses, shares |
184,000
|
|
|
|
Stock options issued to directors and employees as compensation |
|
652,750
|
|
652,750
|
Net loss |
|
|
(4,791,390)
|
(4,791,390)
|
Common stock issued with notes payable |
1
|
56,313
|
|
56,314
|
Common stock issued with notes payable, shares |
4,167
|
|
|
|
Options exercised for cash |
|
2,375
|
|
$ 2,375
|
Options exercised for cash, shares |
297
|
|
|
297
|
Warrants issued with notes payable |
|
327,390
|
|
$ 327,390
|
Balances, value at Jun. 30, 2023 |
$ 83
|
$ 52,869,346
|
$ (54,574,923)
|
$ (1,705,494)
|
Balance, shares at Jun. 30, 2023 |
826,886
|
|
|
|
X |
- DefinitionStock issued during period shares new issues with notes payable.
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v3.23.2
Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Cash flows from operating activities: |
|
|
Net loss |
$ (4,791,390)
|
$ (5,575,853)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Non-cash stock compensation issued for services |
244,176
|
116,766
|
Non-cash stock compensation issued to directors and employees |
51,565
|
328,548
|
Fair value of stock options issued to employees |
652,750
|
861,284
|
Non-cash compensation for services |
90,000
|
30,000
|
Amortization of discount on notes payable |
301,098
|
|
Loss from equity method investment |
23,947
|
189,095
|
Depreciation and amortization |
38,792
|
37,629
|
Changes in assets and liabilities: |
|
|
Accounts receivable |
2,241
|
(6,015)
|
Inventory |
(16,416)
|
5,777
|
Prepaid expenses and other current assets |
(184,513)
|
35,069
|
Accounts payable and accrued expenses |
432,654
|
23,553
|
Accrued compensation |
256,158
|
(72,885)
|
Deferred revenue |
41,311
|
71,457
|
Leasehold liability |
1,829
|
4,655
|
Accrued Interest |
62,938
|
|
Net cash used in operating activities |
(2,792,860)
|
(3,950,920)
|
Cash from investing activities: |
|
|
Payments to acquire property, plant, and equipment |
(261,505)
|
(8,338)
|
Payments to acquire intangible assets |
|
(1,517)
|
Investment in joint ventures |
(8,447)
|
(76,937)
|
Net cash used in investing activities |
(269,952)
|
(86,792)
|
Cash from financing activities: |
|
|
Proceeds from the sale of notes payable |
714,000
|
|
Proceeds from the sale of common stock, net of offering costs |
2,728,938
|
315,000
|
Proceeds from option exercise |
2,375
|
|
Principal payments on note payable |
(360,151)
|
|
Net cash provided by financing activities |
3,085,162
|
315,000
|
Increase (decrease) in cash and cash equivalents |
22,350
|
(3,722,712)
|
Cash and cash equivalents at beginning of period |
90,135
|
5,684,871
|
Cash and cash equivalents at end of period |
112,485
|
1,962,159
|
Supplemental disclosure of cash flow information: |
|
|
Interest |
5,720
|
|
Taxes |
|
2,847
|
Noncash activities: |
|
|
Fair value of warrants issued with debt |
327,390
|
|
Initial ROU asset and lease liability |
$ 2,312,892
|
|
X |
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v3.23.2
Summary of Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
Note
1 – Summary of Significant Accounting Policies
Description
of Business
INVO
Bioscience, Inc. (“INVO” or the “Company”) is a healthcare services fertility company dedicated to expanding
the assisted reproductive technology (“ART”) marketplace by making fertility care accessible and inclusive to people around
the world. The Company’s commercialization strategy is focused on the opening of dedicated “INVO Centers” offering
the INVOcell and IVC procedure (with three centers in North America now operational), the acquisition of US-based, profitable in vitro
fertilization (“IVF”) clinics and the sale and distribution of our technology solution into existing fertility clinics. The
Company’s proprietary technology, INVOcell, is a revolutionary medical device that allows fertilization and early embryo development
to take place in vivo within the woman’s body. This treatment solution is the world’s first intravaginal culture technique
for the incubation of oocytes and sperm during fertilization and early embryo development.
Basis
of Presentation
The
accompanying consolidated financial statements present on a consolidated basis the accounts of the Company and its wholly owned subsidiaries
and controlled affiliates. The Company presents noncontrolling interest within the equity section of its consolidated balance sheets
and the amount of consolidated net income (loss) that is attributable to the Company and to the noncontrolling interest in its consolidated
statement of operations. All significant intercompany accounts and transactions have been eliminated in consolidation.
The
Company uses the equity method of accounting when it owns an interest in an entity whereby it can exert significant influence over but
cannot control the entity’s operations.
The
preparation of the Company’s consolidated financial statements requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated
financial statements and the reported amounts of revenues and expenses during the reporting periods.
The
Company considers events or transactions that have occurred after the consolidated balance sheet date of June 30, 2023, but prior to
the filing of the consolidated financial statements with the SEC in this Quarterly Report on Form 10-Q, to provide additional evidence
relative to certain estimates or to identify matters that require additional disclosure, as applicable. Subsequent events have been evaluated
through the date of the filing of this Quarterly Report on Form 10-Q.
Reclassifications
Certain amounts in the consolidated financial statements for the prior
year have been reclassified to conform to the current year presentation. These reclassifications had no impact on net earnings, financial
position, or cash flows.
Business
Segments
The
Company operates in one segment and therefore segment information is not presented.
Variable
Interest Entities
The
Company’s consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries, and variable interest
entities (“VIE”), where the Company is the primary beneficiary under the provisions of ASC 810, Consolidation (“ASC
810”). A VIE must be consolidated by its primary beneficiary when, along with its affiliates and agents, the primary beneficiary
has both: (i) the power to direct the activities that most significantly impact the VIE’s economic performance; and (ii) the obligation
to absorb losses or the right to receive the benefits of the VIE that could potentially be significant to the VIE. The Company reconsiders
whether an entity is still a VIE only upon certain triggering events and continually assesses its consolidated VIEs to determine if it
continues to be the primary beneficiary. See “Note 3 – Variable Interest Entities” for additional information on the
Company’s VIEs.
Equity
Method Investments
Investments
in unconsolidated affiliates, which the Company exerts significant influence but does not control or otherwise consolidate, are accounted
for using the equity method. Equity method investments are initially recorded at cost. These investments are included in investment in
joint ventures in the accompanying consolidated balance sheets. The Company’s share of the profits and losses from these investments
is reported in loss from equity method joint venture in the accompanying consolidated statements of operations. The Company monitors
its investments for other-than-temporary impairment by considering factors such as current economic and market conditions and the operating
performance of the investees and records reductions in carrying values when necessary.
Use
of Estimates
In
preparing financial statements in conformity with generally accepted accounting principles, management is required to make estimates
and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at
the date of the financial statements and revenues and expenses during the reported period. Actual results could differ from those estimates.
Cash
and Cash Equivalents
For
financial statement presentation purposes, the Company considers time deposits, certificates of deposit and all highly liquid investments
with original maturities of three months or less to be cash and cash equivalents. At times, cash and cash equivalents balances exceed
amounts insured by the Federal Deposit Insurance Corporation.
Inventory
Inventories
consist of raw materials, work in process and finished goods and are stated at the lower of cost or net realizable value, using the first-in,
first-out method as a cost flow method.
Property
and Equipment
The
Company records property and equipment at cost. Property and equipment is depreciated using the straight-line method over the estimated
economic lives of the assets, which are from 3 to 10 years. The Company capitalizes the expenditures for major renewals and improvements
that extend the useful lives of property and equipment. Expenditures for maintenance and repairs are charged to expense as incurred.
The Company reviews the carrying value of long-lived assets for impairment at least annually or whenever events or changes in circumstances
indicate that the carrying amount of an asset may not be recoverable. The recoverability of long-lived assets is measured by a comparison
of its carrying amount to the undiscounted cash flows that the asset or asset group is expected to generate. If such assets are considered
impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the property, if any, exceeds its
fair market value.
Long-
Lived Assets
Long-lived
assets and certain identifiable assets related to those assets are periodically reviewed for impairment whenever circumstances and situations
change such that there is an indication that the carrying amounts may not be recoverable. If the non-discounted future cash flows of
the asset are less than their carrying amount, their carrying amounts are reduced to fair value and an impairment loss recognized. There
was no impairment recorded during the six months ended June 30, 2023, and 2022.
Fair
Value of Financial Instruments
ASC
825-10-50, “Disclosures about Fair Value of Financial Instruments,” requires disclosure of the fair value of certain financial
instruments. The carrying value of cash and cash equivalents, accounts payable and borrowings, as reflected in the balance sheets, approximate
fair value because of the short-term maturity of these instruments.
Effective
January 1, 2008, the Company adopted ASC 820-10, “Fair Value Measurements”, which provides a framework for measuring fair
value under GAAP. ASC 820-10 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability
(an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants
on the measurement date. ASC 820-10 requires that valuation techniques maximize the use of observable inputs and minimize the use of
unobservable inputs.
Income
Taxes
The
Company is subject to income taxes in the United States and its domestic tax liabilities are subject to the allocation of expenses in
multiple state jurisdictions. The Company uses the asset and liability method to account for income taxes. Under this method, deferred
income tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement
carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured
using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered
or settled. The recoverability of deferred tax assets is evaluated by assessing the adequacy of future expected taxable income from all
sources, including taxable income in prior carryback years, reversal of taxable temporary differences, forecasted operating earnings
and available tax planning strategies. To the extent the Company does not consider it more-likely-than-not that a deferred tax asset
will be recovered, a valuation allowance is established.
Concentration
of Credit Risk
Cash
includes amounts deposited in financial institutions in excess of insurable Federal Deposit Insurance Corporation (“FDIC”)
limits. As of June 30, 2023, the Company did not have cash balances in excess of FDIC limits.
Revenue
Recognition
The
Company recognizes revenue on arrangements in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”).
The core principle of ASC 606 is to recognize revenues when promised goods or services are transferred to customers in an amount that
reflects the consideration to which an entity expects to be entitled for those goods or services ASC 606 requires companies to assess
their contracts to determine the timing and amount of revenue to recognize under the new revenue standard. The model has a five-step
approach:
1. |
Identify the contract with
the customer. |
|
|
2. |
Identify the performance
obligations in the contract. |
|
|
3. |
Determine the total transaction
price. |
|
|
4. |
Allocate the total transaction
price to each performance obligation in the contract. |
|
|
5. |
Recognize as revenue when
(or as) each performance obligation is satisfied. |
Revenue
generated from the sale of INVOcell is typically recognized at the time the product is shipped, at which time the title passes to the
customer, and there are no further performance obligations.
Revenue
generated from clinical and lab services related at the Company’s affiliated INVO Centers is typically recognized at the time the
service is performed.
Stock
Based Compensation
The
Company accounts for stock-based compensation under the provisions of Accounting Standards Codification (“ASC”) subtopic
718-10, Compensation (“ASC 718-10”). This statement requires the Company to measure the cost of employee services received
in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized over the period
in which the employee is required to provide service or based on performance goals in exchange for the award, which is usually the vesting
period.
Loss
Per Share
Basic
loss per share calculations are computed by dividing net loss by the weighted-average number of common shares outstanding. Diluted earnings
per share are computed similar to basic earnings per share except that the denominator is increased to include potentially dilutive securities.
The Company’s diluted loss per share is the same as the basic loss per share for the three and six months ended June 30, 2023,
and 2022, as the inclusion of any potential shares would have had an anti-dilutive effect due to the Company generating a loss.
Schedule of Earnings Per Share Basic and Diluted
| |
| | |
| | |
| | |
| |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net loss (numerator) | |
$ | (2,240,511 | ) | |
| (2,801,541 | ) | |
| (4,791,390 | ) | |
| (5,575,853 | ) |
Basic and diluted weighted-average number of common shares outstanding (denominator) | |
| 732,255 | | |
| 605,760 | | |
| 677,684 | | |
| 604,123 | |
Basic weighted-average number of common shares outstanding (denominator) | |
| 732,255 | | |
| 605,760 | | |
| 677,684 | | |
| 604,123 | |
Basic and diluted net loss per common share | |
| (3.06 | ) | |
| (4.62 | ) | |
| (7.07 | ) | |
| (9.23 | ) |
Basic net loss per common share | |
| (3.06 | ) | |
| (4.62 | ) | |
| (7.07 | ) | |
| (9.23 | ) |
The
Company has excluded the following dilutive securities from the calculation of fully diluted shares outstanding because the result would
have been anti-dilutive:
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share
| |
| | |
| |
| |
As of June 30, | |
| |
2023 | | |
2022 | |
Options | |
| 121,255 | | |
| 74,480 | |
Convertible notes and interest | |
| 55,120 | | |
| - | |
Unit purchase options and warrants | |
| 348,151 | | |
| 13,008 | |
Total | |
| 524,526 | | |
| 87,488 | |
Recently
Adopted Accounting Pronouncements
The
Company has reviewed all recently issued, but not yet effective, accounting pronouncements, and does not believe the future adoption
of any such pronouncements will have a material impact on its financial condition or the results of its operations.
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.23.2
Liquidity
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Liquidity |
Note
2 – Liquidity
Historically,
the Company has funded its cash and liquidity needs primarily through revenue collection, equity financings, and convertible notes. For
the six months ended June 30, 2023, and 2022, the Company incurred a net loss of approximately $4.8 million and $5.6 million, respectively,
and has an accumulated deficit of approximately $54.6 million as of June 30, 2023. Approximately $1.4 million of the net loss was related
to non-cash expenses for the six months ended June 30, 2023, compared to $1.6 million for the six months ended June 30, 2022.
The
Company has been dependent on raising capital from debt and equity financings to meet its needs for cash flow used in operating and investing
activities. During the first six months of 2023, the Company received net proceeds of approximately $2.7 million for the sale of its
common stock par value $0.0001 per share (“Common Stock”) as well as approximately $0.7 million from the sale of convertible
notes. During the first six months of 2022, the Company received proceeds of approximately $0.3 million for the sale of Common Stock.
Over the next 12 months, the Company’s plan includes opening additional INVO Centers, completing the acquisition of Wisconsin Fertility
Institute and pursuing additional IVF clinic acquisitions. Until the Company can generate positive cash from operations, it will need
to raise additional funding to meet its liquidity needs and to execute its business strategy. As in the past, the Company will seek debt
and/or equity financing, which may not be available on reasonable terms, if at all.
Although
the Company’s audited financial statements for the year ended December 31, 2022 were prepared under the assumption that it would
continue operations as a going concern, the report of the Company’s independent registered public accounting firm that accompanies
the Company’s financial statements for the year ended December 31, 2022 contains a going concern qualification in which such firm
expressed substantial doubt about the Company’s ability to continue as a going concern, based on the financial statements at that
time. Specifically, as noted above, the Company has incurred significant operating losses and the Company expects to continue to incur
significant expenses and operating losses as it continues to ramp up the commercialization of INVOcell and develop new INVO Centers.
These prior losses and expected future losses have had, and will continue to have, an adverse effect on the Company’s financial
condition. If the Company cannot continue as a going concern, its stockholders would likely lose most or all of their investment in the
Company.
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v3.23.2
Variable Interest Entities
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Variable Interest Entities |
Note
3 – Variable Interest Entities
Consolidated
VIEs
Bloom
INVO, LLC
On
June 28, 2021, INVO CTR entered into a limited liability company agreement (the “Bloom Agreement”) with Bloom Fertility,
LLC (“Bloom”) to establish a joint venture entity, formed as “Bloom INVO LLC” (the “Georgia JV”),
for the purposes of commercializing INVOcell, and the related IVC procedure, through the establishment of an INVO Center (the “Atlanta
Clinic”) in the Atlanta, Georgia metropolitan area.
In
consideration for INVO’s commitment to contribute up to $800,000 within the 24-month period following the execution of the Bloom
Agreement to support the start-up operations of the Georgia JV, the Georgia JV issued 800 of its units to INVO CTR and in consideration
for Bloom’s commitment to contribute physician services having an anticipated value of up to $1,200,000 over the course of a 24-month
vesting period, the Georgia JV issued 1,200 of its units to Bloom.
The
responsibilities of Bloom include providing all medical services required for the operation of the Atlanta Clinic. The responsibilities
of INVO CTR include providing certain funding to the Georgia JV, lab services quality management, and providing access to and being the
exclusive provider of the INVOcell to the Georgia JV. INVO CTR also performs all required, industry specific compliance and accreditation
functions, and product documentation for product registration.
The
Bloom Agreement provides Bloom with a “profits interest” in the Georgia JV and, in connection with such profits interest,
states that profits and losses be allocated to its members based on a hypothetical liquidation of the Georgia JV. In such a scenario,
liquidation proceeds would be distributed in the following order: (a) to INVO CTR until the difference between its capital contributions
and distributions equals $0; (b) to Bloom until its distributions equal 150% of the liquidation amounts distributed to INVO CTR (a “catch-up”
to rebalance the distributions between members); and (c) thereafter on a pro rata basis. The Georgia JV had no assets or liabilities
at the time the units were issued, and, as of June 30, 2023, INVO CTR had made capital contributions greater than the net loss of the
Georgia JV. As such, the entire net loss was allocated to INVO CTR, and no loss was allocated to the noncontrolling interest of Bloom.
The
Georgia JV opened to patients on September 7, 2021.
The
Company determined the Georgia JV is a VIE, and that the Company is its primary beneficiary because the Company has an obligation to
absorb losses that are potentially significant and the Company controls the majority of the activities that impact the Georgia JV’s
economic performance, specifically control of the INVOcell and lab services quality management. As a result, the Company consolidated
the Georgia JV’s results with its own. As of June 30, 2023, the Company invested $0.9 million in the Georgia JV in the form of
capital contributions as well as $0.5 million in the form of a note. For the six months ended June 30, 2023 and 2022, the Georgia JV
recorded net losses of $0.1 million and $0.3 million respectively. Noncontrolling interest in the Georgia JV was $0.
Unconsolidated
VIEs
HRCFG
INVO, LLC
On
March 10, 2021, INVO CTR entered into a limited liability company agreement with HRCFG, LLC (“HRCFG”) to form a joint venture
for the purpose of establishing an INVO Center in Birmingham, Alabama. The name of the joint venture entity is HRCFG INVO, LLC (the “Alabama
JV”). The Company also provides certain funding to the Alabama JV. Each party owns 50% of the Alabama JV.
The
Alabama JV opened to patients on August 9, 2021.
The
Company determined the Alabama JV is a VIE, and that there is no primary beneficiary. As a result, the Company will use the equity method
to account for its interest in the Alabama JV. As of June 30, 2023, the Company invested $1.6 million in the Alabama JV in the form of
a note. For the six months ended June 30, 2023, the Alabama JV recorded net income of $2 thousand, of which the Company recognized a
gain from equity method investments of $805. For the six months ended June 30, 2022, the Alabama JV recorded a net loss of $0.3 million,
of which the Company recognized a loss from equity method investments of $0.2 million.
Positib
Fertility, S.A. de C.V.
On
September 24, 2020, INVO CTR entered into a Pre-Incorporation and Shareholders Agreement with Francisco Arredondo, MD PLLC (“Arredondo”)
and Security Health LLC, a Texas limited liability company (“Ramirez”, and together with INVO CTR and Arredondo, the “Shareholders”)
under which the Shareholders will commercialize the IVC procedure and offer related medical treatments in Mexico. Each party owns one-third
of the Mexican incorporated company, Positib Fertility, S.A. de C.V. (the “Mexico JV”).
The
Mexico JV opened to patients on November 1, 2021.
The
Company determined the Mexico JV is a VIE, and that there is no primary beneficiary. As a result, the Company will use the equity method
to account for its interest in the Mexico JV. As of June 30, 2023, the Company invested $0.1 million in the Mexico JV. For the six months
ended June 30, 2023 and 2022, the Mexico JV recorded net losses of $74 thousand and $90 thousand, respectively, of which the Company
recognized a loss from equity method investments of $24 thousand and $30 thousand, respectively.
The
following table summarizes our investments in unconsolidated VIEs:
Schedule of Investments in Unconsolidated Variable Interest Entities
| |
| |
Carrying Value as of | |
| |
Location | |
Percentage Ownership | | |
June 30, 2023 | | |
December 31, 2022 | |
HRCFG INVO, LLC | |
Alabama, United States | |
| 50 | % | |
$ | 1,023,346 | | |
| 1,106,905 | |
Positib Fertility, S.A. de C.V. | |
Mexico | |
| 33 | % | |
| 109,019 | | |
| 130,960 | |
Total investment in unconsolidated VIEs | | | |
$ | 1,132,365 | | |
| 1,237,865 | |
Earnings
from investments in unconsolidated VIEs were as follows:
Schedule of Earnings from Investments in Unconsolidated Variable Interest Entities
| |
| | |
| | |
| | |
| |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
HRCFG INVO, LLC | |
$ | 19,474 | | |
$ | (104,255 | ) | |
$ | 805 | | |
$ | (159,175 | ) |
Positib Fertility, S.A. de C.V. | |
| (15,686 | ) | |
| (13,723 | ) | |
| (24,752 | ) | |
| (29,920 | ) |
Total earnings from unconsolidated VIEs | |
| 3,788 | | |
| (117,978 | ) | |
| (23,947 | ) | |
| (189,095 | ) |
The
following tables summarize the combined unaudited financial information of our unconsolidated VIEs:
Schedule of Financial Information of Investments in Unconsolidated Variable Interest Entities
| |
| | |
| | |
| | |
| |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Statements of operations: | |
| | |
| | |
| | |
| |
Operating revenue | |
$ | 458,069 | | |
$ | 166,477 | | |
$ | 807,396 | | |
$ | 336,312 | |
Operating expenses | |
| (466,184 | ) | |
| (415,665 | ) | |
| (880,050 | ) | |
| (744,421 | ) |
Net loss | |
| (8,115 | ) | |
| (249,188 | ) | |
| (72,654 | ) | |
| (408,109 | ) |
| |
| | |
| |
| |
June 30, 2023 | | |
December 31, 2022 | |
Balance sheets: | |
| | | |
| | |
Current assets | |
$ | 416,948 | | |
| 261,477 | |
Long-term assets | |
| 1,057,010 | | |
| 1,094,490 | |
Current liabilities | |
| (513,709 | ) | |
| (396,619 | ) |
Long-term liabilities | |
| (121,773 | ) | |
| (107,374 | ) |
Net assets | |
$ | 838,476 | | |
| 851,974 | |
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v3.23.2
Agreements and Transactions with VIE’s
|
6 Months Ended |
Jun. 30, 2023 |
Agreements And Transactions With Vies |
|
Agreements and Transactions with VIE’s |
Note
4 – Agreements and Transactions with VIE’s
The
Company sells the INVOcell to its consolidated and unconsolidated VIEs and anticipates continuing to do so in the ordinary course of
business. All intercompany transactions with consolidated entities are eliminated in the Company’s consolidated financial statements.
Per ASC 323-10-35-8 the Company eliminates any sales to an unconsolidated VIE for INVOcell inventory that the VIE still has remaining
on the books at period end.
The
following table summarizes the Company’s transactions with VIEs:
Summary of Transaction with Variable Interest Entities
| |
| | |
| | |
| | |
| |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Bloom Invo, LLC | |
| | | |
| | | |
| | | |
| | |
INVOcell revenue | |
$ | 6,000 | | |
$ | - | | |
$ | 10,500 | | |
$ | - | |
Unconsolidated VIEs | |
| | | |
| | | |
| | | |
| | |
INVOcell revenue | |
$ | 6,750 | | |
$ | 9,000 | | |
$ | 9,750 | | |
$ | 16,500 | |
The
Company had balances with VIEs as follows:
Summary of Balances with Variable Interest Entities
| |
| | |
| |
| |
June 30, 2023 | | |
December 31, 2022 | |
Bloom Invo, LLC | |
| | | |
| | |
Accounts receivable | |
$ | 12,000 | | |
| 13,500 | |
Notes payable | |
| 472,839 | | |
| 468,031 | |
Unconsolidated VIEs | |
| | | |
| | |
Accounts receivable | |
$ | 34,935 | | |
| 46,310 | |
|
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v3.23.2
Inventory
|
6 Months Ended |
Jun. 30, 2023 |
Inventory Disclosure [Abstract] |
|
Inventory |
Note
5 – Inventory
Components
of inventory are:
Schedule of Inventory
| |
June 30, 2023 | | |
December 31, 2022 | |
Raw materials | |
$ | 62,745 | | |
$ | 68,723 | |
Finished goods | |
| 217,273 | | |
| 194,879 | |
Total inventory | |
$ | 280,018 | | |
$ | 263,602 | |
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v3.23.2
Property and Equipment
|
6 Months Ended |
Jun. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Property and Equipment |
Note
6 – Property and Equipment
The
estimated useful lives and accumulated depreciation for equipment are as follows as of June 30, 2023, and December 31, 2022:
Schedule of Estimated Useful Lives of Property and Equipment
|
|
Estimated
Useful Life |
|
Manufacturing equipment |
|
6 to 10 years |
|
Medical equipment |
|
7 to 10 years |
|
Office equipment |
|
3 to 7 years |
|
Schedule of Property and Equipment
| |
| | |
| |
| |
June 30, 2023 | | |
December 31, 2022 | |
Manufacturing equipment | |
$ | 132,513 | | |
$ | 132,513 | |
Medical equipment | |
| 283,065 | | |
| 283,065 | |
Office equipment | |
| 77,601 | | |
| 77,601 | |
Leasehold improvements | |
| 358,322 | | |
| 96,817 | |
Less: accumulated depreciation | |
| (192,059 | ) | |
| (153,267 | ) |
Total equipment, net | |
$ | 659,442 | | |
$ | 436,729 | |
During
the three months ended June 30, 2023, and 2022, the Company recorded depreciation expense of $19,705 and $21,630, respectively.
During
the six months ended June 30, 2023, and 2022, the Company recorded depreciation expense of $38,792 and $36,725, respectively.
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- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections.
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v3.23.2
Intangible Assets
|
6 Months Ended |
Jun. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Intangible Assets |
Note
7 – Intangible Assets
The
Company capitalizes the initial expense related to establishing patents by country and then amortizes the expense over the life of the
patent, typically 20 years. It then expenses annual filing fees to maintain the patents. The Company regularly reviews the value of its
patents in the marketplace in proportion to the expense it must spend to maintain the patent. The Company fully impaired its patents
as of December 31, 2022.
During
the three months ended June 30, 2023, and 2022, the Company recorded amortization expenses related to patents of $nil and $452, respectively.
During
the six months ended June 30, 2023, and 2022, the Company recorded amortization expenses related to patents of $nil and $904, respectively.
The
trademarks have an indefinite life and therefore are not amortized. Trademarks are periodically reviewed for impairment whenever circumstances
and situations change such that there is an indication that the carrying amounts may not be recoverable. The Company fully impaired its
trademarks as of December 31, 2022.
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- DefinitionThe entire disclosure for all or part of the information related to intangible assets.
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v3.23.2
Leases
|
6 Months Ended |
Jun. 30, 2023 |
Leases |
|
Leases |
Note
8 – Leases
The
Company has various operating lease agreements in place for its office and joint ventures. Per FASB’s ASU 2016-02, Leases Topic
842 (“ASU 2016-02”), effective January 1, 2019, the Company is required to report a right-of-use asset and corresponding
liability to report the present value of the total lease payments, with appropriate interest calculation. Per the terms of ASU 2016-02,
the Company can use its implicit interest rate, if known, or applicable federal rate otherwise. Since the Company’s implicit interest
rate was not readily determinable, the Company utilized the applicable federal rate, as of the commencement of the lease. Lease renewal
options included in any lease are considered in the lease term if it is reasonably certain the Company will exercise the option to renew.
The Company’s operating lease agreements do not contain any material restrictive covenants.
As
of June 30, 2023, the Company’s lease components included in the consolidated balance sheet were as follows:
Schedule of Lease Components
| |
| |
| |
Lease component | |
Balance sheet classification | |
June 30, 2023 | |
Assets | |
| |
| | |
ROU assets – operating lease | |
Other assets | |
$ | 4,004,962 | |
Total ROU assets | |
| |
$ | 4,004,962 | |
| |
| |
| | |
Liabilities | |
| |
| | |
Current operating lease liability | |
Current liabilities | |
$ | 227,026 | |
Long-term operating lease liability | |
Other liabilities | |
| 3,873,289 | |
Total lease liabilities | |
| |
$ | 4,100,315 | |
Future
minimum lease payments as of June 30, 2023 were as follows:
Schedule of Future Minimum Lease Payments
| |
| | |
2023 | |
| 156,465 | |
2024 | |
| 392,869 | |
2025 | |
| 392,688 | |
2026 | |
| 401,581 | |
2027 and beyond | |
| 4,197,510 | |
Total future minimum lease payments | |
$ | 5,541,113 | |
Less: Interest | |
| (1,440,798 | ) |
Total operating lease liabilities | |
$ | 4,100,315 | |
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- DefinitionThe entire disclosure for operating leases of lessee. Includes, but is not limited to, description of operating lease and maturity analysis of operating lease liability.
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v3.23.2
Notes Payable
|
6 Months Ended |
Jun. 30, 2023 |
Debt Disclosure [Abstract] |
|
Notes Payable |
Note
9 – Notes Payable
Notes
payables consisted of the following:
Schedule
of Notes Payable
| |
| | |
| |
| |
June 30, 2023 | | |
December 31, 2022 | |
Less debt discount | |
| (285,961 | ) | |
| (107,356 | ) |
Related party demand notes with a 10% financing fee. 10% annual interest starting January 31, 2023. Notes are callable starting September 30, 2023 | |
$ | 770,000 | | |
$ | 770,000 | |
Convertible notes. 10% annual interest. Conversion price of $10.00-$12.00 | |
| 410,000 | | |
| 100,000 | |
Convertible debentures. 8% interest. Conversion price of $10.40 | |
| 139,849 | | |
| - | |
Less debt discount | |
| (285,961 | ) | |
| (107,356 | ) |
Total, net of discount | |
$ | 1,033,888 | | |
$ | 762,644 | |
Related
Party Demand Notes
In
the fourth quarter of 2022, the Company received $500,000 through the issuance of five demand notes (the “JAG Notes”) from
a related party, JAG Multi Investments LLC (“JAG”). The Company’s CFO is a beneficiary of JAG but does not have any
control over JAG’s investment decisions with respect to the Company. The JAG Notes accrue 10% annual interest from the date of
issuance. At maturity, the Company agreed to pay outstanding principal, a 10% financing fee and accrued interest.
In
consideration for subscribing to the JAG Note for $100,000 dated December 29, 2022, and for agreeing to extend the date on which the
other JAG Notes are callable to March 31, 2023, the Company issued JAG a warrant to purchase 17,500 shares of Common Stock. The warrant
may be exercised for a period of five (5) years from issuance at a price of $10.00 per share. The financing fees for said JAG Note and
the fair value of the warrant issued were capped at the total proceeds. The relative fair value of the warrant was recorded as a debt
discount and as of June 30, 2023 the Company had fully amortized the discount. On July 10, 2023 JAG agreed to extend the date on which
the JAG Notes are callable to September 30, 2023.
In
the fourth quarter of 2022, the Company received $200,000 through the issuance of demand promissory notes of which (1) $100,000 was received
from our chief executive officer, Steven Shum ($60,000 on November 29, 2022, $15,000 on December 2, 2022, and $25,000 on December 13,
2022) and (2) $100,000 was received from an entity controlled by our chief financial officer, Andrea Goren ($75,000 on November 29, 2022
and $25,000 on December 13, 2022). These notes accrue 10% annual interest accrues from the date of issuance. These notes are callable
with 10 days prior written notice. At maturity, the Company agreed to pay outstanding principal, a 10% financing fee and accrued interest.
The
financing fees for all demand notes were recorded as a debt discount and as of June 30, 2023 the Company had fully amortized the discount.
For
the six months ended June 30, 2023, the Company incurred $42,758 in interest related to these demand notes.
Jan
and March 2023 Convertible Notes
In
January and March 2023, the Company issued $410,000 of convertible notes, for $310,000 in cash and the conversion of $100,000 of demand
notes from the fourth quarter of 2022. These convertible notes were issued with fixed conversion prices of $10.00 (for the $275,000 issued
in January 2023) and $12.00 (for the $135,000 issued in March 2023) and (ii) 5-year warrants to purchase 19,375 shares of the Common
Stock at an exercise price of $20.00.
The
cumulative fair value of the warrants at issuance was $132,183. This was recognized as a debt discount and will be amortized on a straight-line
basis over the life of the respective notes. For the six months ending June 30, 2023 the Company amortized $59,238 of the debt discount
and as of June 30, 2023 had a remaining debt discount balance of $72,945.
Interest
on these notes accrues at a rate of ten percent (10%) per annum and is payable at the holder’s option either in cash or in shares
of the Common Stock at the conversion price set forth in the notes on December 31, 2023, unless converted earlier. For the six months
ended June 30, 2023 the Company incurred $17,456 in interest related to these convertible notes.
All
amounts due under these notes are convertible at any time after the issuance date, in whole or in part (subject to rounding for fractional
shares), at the option of the holders into the Common Stock at a fixed conversion price for the notes as described above.
February
2023 Convertible Debentures
On
February 3, and February 17, 2023, the Company entered into securities purchase agreements (the “February Purchase Agreements”)
with accredited investors (the “February Investors”) for the purchase of (i) convertible debentures of the Company in the
aggregate original principal amount of $500,000 (the “February Debentures”) for a purchase price of $450,000, (ii) warrants
(the “February Warrants”) to purchase 12,500 shares (the “February Warrant Shares”) of Common Stock at an exercise
price of $15.00 per share, and (iii) 4,167 shares of Common Stock issued as an inducement for issuing the February Debentures. The proceeds,
net of placement agent and legal fees, were used for working capital and general corporate purposes.
The
cumulative fair value of the warrants at issuance was $291,207. This was recognized as a debt discount and will be amortized on a straight-line
basis over the life of the respective notes. For the six months ending June 30, 2023 the Company amortized $86,642 of the debt discount
and as of June 30, 2023 had a remaining debt discount balance of $213,016.
Pursuant
to the February Debentures, interest on the February Debentures accrues at a rate of eight percent (8%) per annum and is payable at maturity,
one year from the date of the February Debentures. For the six months ended June 30, 2023 the Company incurred $8,444 in interest on
the February Debentures.
All
amounts due under the February Debentures are convertible at any time after the issuance date, in whole or in part, at the option of
the February Investors into Common Stock at an initial price of $10.40 per share. This conversion price is subject to adjustment for
stock splits, combinations or similar events and anti-dilution provisions, among other adjustments and is subject to a floor price.
The
Company may prepay the February Debentures at any time in whole or in part by paying a sum of money equal to 105% of the principal amount
to be redeemed, together with accrued and unpaid interest.
While
any portion of each February Debenture remains outstanding, if the Company receives cash proceeds of more than $2,000,000 (the “Minimum
Threshold”) in the aggregate from any source or series of related or unrelated sources, the February Investors shall have the right
in their sole discretion to require the Company to immediately apply up to 50% of all proceeds received by the Company above the Minimum
Threshold to repay the outstanding amounts owed under the February Debentures. The Company used $360,151 in proceeds from the RD Offering
(as described in Note 11 below) to repay a portion of the February Debentures, leaving $139,849 of the February Debentures outstanding
as of June 30, 2023. On August 8, 2023, the Company repaid the remaining balance of $139,849 with proceeds from the August Public Offering
(as described in Note 16 below).
The
February Warrants include anti-dilution protection whereby a subsequent offering priced below the February Warrants’ strike
price then in effect would entitle the February Investors to a reduction of such strike price to the price of such subsequent
offering and an increase in the February Warrant Shares determined by dividing the dollar amount for which the February Warrants are
exercisable by such lower strike price. As a result of the $2.85
strike of the August Public Offering (as described in Note 16 below), the February Warrants now entitle the February Investors to
purchase a total 65,790
at a price of $2.85
per February Warrant Share.
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v3.23.2
Related Party Transactions
|
6 Months Ended |
Jun. 30, 2023 |
Related Party Transactions [Abstract] |
|
Related Party Transactions |
Note
10 – Related Party Transactions
In
the fourth quarter of 2022, the Company received $700,000 through the issuance of demand notes from related parties, as follows: (a)
$500,000 from JAG; (b) $100,000 from our chief executive officer, Steve Shum; and (c) $100,000 from our chief financial officer, Andrea
Goren. The Company’s CFO is a beneficiary of JAG but does not have any control over JAG’s investment decisions with respect
to the Company. See Note 9 of the Notes to Consolidated Financial Statements for additional information.
As
of June 30, 2023 the Company owed accounts payable to related parties totaling $142,176, primarily related to unpaid employee expense
reimbursements and unpaid board fees.
|
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- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.23.2
Stockholders’ Equity
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
Stockholders’ Equity |
Note
11 – Stockholders’ Equity
Reverse
Stock Split
On
June 28, 2023, the Company’s board of directors approved a reverse stock split of the Company’s common stock at a ratio of
1-for-20 and also approved a proportionate decrease in its authorized common stock to 6,250,000 shares from 125,000,000. On July 26,
2023, the Company filed a certificate of change (with an effective date of July 28, 2023) with the Nevada Secretary of State pursuant
to Nevada Revised Statutes 78.209 to effectuate a 1-for-20 reverse stock split of its outstanding common stock. On July 27, 2023, the
Company received notice from Nasdaq that the reverse split would take effect at the open of business on July 28, 2023, and the reverse
stock split took effect on that date. All share information included in this Form 10-Q has been reflected as if the reverse stock split occurred as of
the earliest period presented.
February
2023 Equity Purchase Agreement
On
February 3, 2023, the Company entered into an equity purchase agreement (the “ELOC”) and registration rights agreement (the
“ELOC RRA”) with an accredited investor (the “Feb 3 Investor”) pursuant to which the Company has the right, but
not the obligation, to direct the Feb 3 Investor to purchase up to $10.0 million (the “Maximum Commitment Amount”) of shares
of Common Stock, in multiple tranches. Further, under the ELOC and subject to the Maximum Commitment Amount, the Company has the right,
but not the obligation, to submit notices to the Feb 3 Investor to purchase shares of Common Stock (i) in a minimum amount of not less
than $25,000 and (ii) in a maximum amount of up to the lesser of (a) $750,000 or (b) 200% of the Company’s average daily trading
value of the Common Stock.
Also
on February 3, 2023, the Company issued to the Feb 3 Investor 7,500 shares of Common Stock for its commitment to enter into the ELOC.
The
obligation of the Feb 3 Investor to purchase shares of Common Stock pursuant to the ELOC ends on the earlier of (i) the date on which
the purchases under the ELOC equal the Maximum Commitment Amount, (ii) 24 months after the date of the ELOC (February 3, 2025), (iii)
written notice of termination by the Company, (iv) the date that the ELOC RRA is no longer effective after its initial effective date,
or (v) the date that the Company commences a voluntary case or any person or entity commences a proceeding against the Company pursuant
to or within the meaning of federal or state bankruptcy law, a custodian is appointed for the Company or for all or substantially all
of its property, or the Company makes a general assignment for the benefit of its creditors (the “Commitment Period”).
During
the Commitment Period, the price that Feb 3 Investor will pay to purchase the shares of Common Stock that it is obligated to purchase
under the ELOC shall be 97% of the “market price,” which is defined as the lesser of (i) the lowest closing price of our
Common Stock during the 7 trading day-period following the clearance date associated with the applicable put notice from the Company
or (ii) the lowest closing bid price of the Common Stock on the principal trading market for the Common Stock (currently, the Nasdaq
Capital Market) on the trading day immediately preceding a put date.
March
2023 Registered Direct Offering
On
March 23, 2023, INVO entered into a securities purchase agreement (the “March Purchase Agreement”) with a certain
institutional investor, pursuant to which the Company agreed to issue and sell to such investor (i) in a registered direct offering
(the “RD Offering”), 69,000
shares of Common Stock, and a pre-funded warrant (the “Pre-Funded Warrant”) to purchase up to 115,000
shares of Common Stock, at an exercise price of $0.20
per share, and (ii) in a concurrent private placement (the “March Warrant Placement”), a common stock purchase warrant
(the “March Warrant”), exercisable for an aggregate of up to 276,000
shares of Common Stock, at an exercise price of $12.60
per share. The securities to be issued in the RD Offering (priced at the marked under Nasdaq rules) were offered pursuant to the
Company’s shelf registration statement on Form S-3 (File 333-255096), initially filed by the Company with the SEC under the
Securities Act of 1933, as amended (the “Securities Act”), on April 7, 2021 and declared effective on April 16, 2021.
All Pre-Funded Warrants were exercised by the investor in June 2023.
The
March Warrant (and the shares of Common Stock issuable upon the exercise of the March Warrant) was not registered under the Securities
Act and was offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of
the Securities Act and Rule 506(b) promulgated thereunder. The March Warrant is immediately exercisable upon issuance, will expire eight
years from the date of issuance, and in certain circumstances may be exercised on a cashless basis.
On
March 27, 2023, the Company closed the RD Offering and March Warrant Placement, raising gross proceeds of approximately $3 million before
deducting placement agent fees and other offering expenses payable by the Company. In the event the March Warrant is fully exercised
for cash, the Company would receive additional gross proceeds of approximately $3.5 million. Under the March Purchase Agreement, the
Company may use a portion of the net proceeds of the offering to (a) repay February Debentures, and (b) to pay the down payment for Wisconsin
Fertility acquisition. The remainder of the net proceeds will be used for working capital, capital expenditures, and other general corporate
purposes. The Company used $383,879 in proceeds to repay a portion of the February Debentures and related fees and interest and the remainder
of the proceeds are being used for working capital and general corporate purposes.
Under
the March Purchase Agreement, the Company is required within 30 days of the closing date of the March Warrant Placement to file a registration
statement on Form S-1 (the “Resale Registration Statement”) registering the resale of the shares of Common Stock issuable
upon the exercise of the March Warrant. The Company is required to use commercially reasonable efforts to cause such registration to
become effective within 75 days of the closing date of the offering (or 120 days if the registration statement is subject to a full review
by the SEC), and to keep the Resale Registration Statement effective at all times until no shares of Common Stock remain exercisable
under the March Warrant.
In
addition, pursuant to certain “lock-up” agreements, our officers and directors have agreed, for a period of 180 days from
the date of the RD Offering and March Warrant Placement, not to engage in any of the following, whether directly or indirectly, without
the consent of the March Purchase Agreement investor: offer to sell, sell, contract to sell pledge, grant, lend, or otherwise transfer
or dispose of our common stock or any securities convertible into or exercisable or exchangeable for Common Stock (the “Lock-Up
Securities”); enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences
of ownership of the Lock-Up Securities; make any demand for or exercise any right or cause to be filed a registration statement, including
any amendments thereto, with respect to the registration of any Lock-Up Securities; enter into any transaction, swap, hedge, or other
arrangement relating to any Lock-Up Securities subject to customary exceptions; or publicly disclose the intention to do any of the foregoing.
Six
Months Ended June 30, 2023
During
the six months ended June 30, 2023, the Company issued 3,994 shares of Common Stock to employees and directors and 12,202 shares of Common
Stock to consultants with a fair value of $51,565 and $106,176, respectively. The shares were issued under the Company’s 2019 Stock
Incentive Plan (the “2019 Plan”).
During
the six months ended June 30, 2023, the Company issued 297 shares of Common Stock upon the exercise of options. The Company received
proceeds of $2,375.
In
February 2023, the Company issued 4,167 shares of Common Stock with a fair value of $56,313 as inducement for issuing the February Debentures.
The fair value of the shares was recognized as a discount to the February Debentures and will be amortized over the life of the notes.
In
February 2023, the Company 7,500 shares of Common Stock in connection with the ELOC with a fair value of $93,000 that was expensed in
the period.
In
March 2023, the Company issued 69,000 shares of Common Stock in the RD Offering and March Warrant Placement. The Company received net
proceeds of approximately $2.7 million.
In
May 2023, the Company issued 6,115 shares of Common Stock to consultants in consideration of services rendered with a fair value of $45,000.
These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended.
The Company did not receive any cash proceeds from this issuance.
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- DefinitionThe entire disclosure for equity.
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v3.23.2
Equity-Based Compensation
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
Equity-Based Compensation |
Note
12 – Equity-Based Compensation
Equity
Incentive Plans
In
October 2019, the Company adopted the 2019 Plan. Under the 2019 Plan, the Company’s board of directors is authorized to grant stock
options to purchase Common Stock, restricted stock units, and restricted shares of Common Stock to its employees, directors, and consultants.
The 2019 Plan initially provided for the issuance of 25,000 shares. A provision in the 2019 Plan provides for an automatic annual increase
equal to 6% of the total number of shares of Common Stock outstanding on December 31 of the preceding calendar year. In January 2023,
the number of available shares increased by 36,498 shares bringing the total shares available under the 2019 Plan to 125,000.
Options
granted under the 2019 Plan generally have a life of 3 to 10 years and exercise prices equal to or greater than the fair market value
of the Common Stock as determined by the Company’s board of directors. Vesting for employees typically occurs over a three-year
period.
The
following table sets forth the activity of the options to purchase Common Stock under the 2019 Plan.
Schedule of Stock Options Activity
| |
Number of Shares | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
Outstanding as of December 31, 2022 | |
| 64,850 | | |
$ | 68.00 | | |
$ | - | |
Granted | |
| 59,048 | | |
| 7.74 | | |
| - | |
Exercised | |
| (297 | ) | |
| 8.00 | | |
| - | |
Canceled | |
| (2,346 | ) | |
| 72.38 | | |
| - | |
Balance as of June 30, 2023 | |
| 121,255 | | |
$ | 2.10 | | |
$ | - | |
Exercisable as of June 30, 2023 | |
| 71,251 | | |
$ | 62.42 | | |
$ | - | |
The
fair value of each option granted is estimated as of the grant date using the Black-Scholes option pricing model with the following assumptions:
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions
| |
| Six months ended June 30, |
| |
| 2023 | | |
| 2022 | |
Risk-free interest rate range | |
| 3.6-3.69 % | | |
| 1.6 to 1.9 % | |
Expected life of option-years | |
| 5-5.63 | | |
| 5.25 to 5.75 | |
Expected stock price volatility | |
| 106.6-114.9 % | | |
| 110.4 to 113.2 % | |
Expected dividend yield | |
| - | % | |
| - | % |
The
risk-free interest rate is based on U.S. Treasury interest rates, the terms of which are consistent with the expected life of the stock
options. Expected volatility is based upon the average historical volatility of the Common Stock over the period commensurate with the
expected term of the related instrument. The expected life and estimated post-employment termination behavior is based upon historical
experience of homogeneous groups, executives and non-executives, within the Company. The Company does not currently pay dividends on
its Common Stock, nor does it expect to do so in the foreseeable future.
Schedule of Share Based Payments Arrangements Options Exercised and Options Vested
| |
Total Intrinsic Value of Options Exercised | | |
Total Fair Value of Options Vested | |
Year ended December 31, 2022 | |
$ | - | | |
$ | 1,616,401 | |
Six months ended June 30, 2023 | |
$ | - | | |
$ | 654,925 | |
For
the six months ended June 30, 2023, the weighted average grant date fair value of options granted was $6.38 per share. The Company estimates
the fair value of options at the grant date using the Black-Scholes model. For all stock options granted through June 30, 2023, the weighted
average remaining service period is 1 year.
Restricted
Stock and Restricted Stock Units
In
the six months ended June 30, 2023, the Company granted 13,272 restricted stock units and shares of restricted stock to certain employees,
directors, and consultants under the 2019 Plan. Restricted stock issued to employees, directors, and consultants generally vest either
at grant or vest over a period of one year from the date of grant.
The
following table summarizes the Company’s restricted stock awards activity under the 2019 Plan during the six months ended June
30, 2023:
Schedule of Aggregate Restricted Stock Awards and Restricted Stock Unit Activity
| |
Number of Unvested Shares | | |
Weighted Average Grant Date Fair Value | | |
Aggregate Value of Shares | |
| |
| | |
| | |
| |
Balance as of December 31, 2022 | |
| 3,533 | | |
$ | 8.40 | | |
$ | 29,949 | |
Granted | |
| 13,272 | | |
| 8.88 | | |
| 97,172 | |
Vested | |
| (16,505 | ) | |
| 18.82 | | |
| 286,597 | |
Forfeitures | |
| - | | |
| - | | |
| - | |
Balance as of June 30, 2023 | |
| 300 | | |
| 18.42 | | |
| 5,525 | |
|
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- DefinitionThe entire disclosure for shareholders' equity and share-based payment arrangement. Includes, but is not limited to, disclosure of policy and terms of share-based payment arrangement, deferred compensation arrangement, and employee stock purchase plan (ESPP).
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v3.23.2
Unit Purchase Options and Warrants
|
6 Months Ended |
Jun. 30, 2023 |
Unit Purchase Options And Warrants |
|
Unit Purchase Options and Warrants |
Note
13 – Unit Purchase Options and Warrants
The
following table sets forth the activity of unit purchase options:
Schedule
of Unit Purchase Stock Options Activity
| |
Number of Unit Purchase Options | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
Outstanding as of December 31, 2022 | |
$ | 4,649 | | |
$ | 64.00 | | |
$ | - | |
Granted | |
| - | | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | | |
| - | |
Canceled | |
| - | | |
| - | | |
| - | |
Balance as of June 30, 2023 | |
$ | 4,649 | | |
$ | 64.00 | | |
$ | - | |
The
following table sets forth the activity of warrants:
Schedule
of Warrants Activity
| |
Number of Warrants | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
Outstanding as of December 31, 2022 | |
| 25,864 | | |
$ | 30.20 | | |
$ | - | |
Granted | |
| 432,618 | | |
| 12.60 | | |
| - | |
Exercised | |
| (115,000 | ) | |
| 0.20 | | |
| - | |
Canceled | |
| - | | |
| - | | |
| - | |
Balance as of June 30, 2023 | |
| 378,849 | | |
$ | 20.41 | | |
$ | - | |
|
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v3.23.2
Income Taxes
|
6 Months Ended |
Jun. 30, 2023 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
Note
14 – Income Taxes
The
Company uses the asset and liability method to account for income taxes. Under this method, deferred income tax assets and liabilities
are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing
assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected
to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred
tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. If a carryforward
exists, the Company decides as to whether the carryforward will be utilized in the future. Currently, a valuation allowance is established
for all deferred tax assets and carryforwards as their recoverability is deemed to be uncertain. If the Company’s expectations
for future operating results at the federal or at the state jurisdiction level vary from actual results due to changes in healthcare
regulations, general economic conditions, or other factors, it may need to adjust the valuation allowance, for all or a portion of the
Company’s deferred tax assets. The Company’s income tax expense in future periods will be reduced or increased to the extent
of offsetting decreases or increases, respectively, in the Company’s valuation allowance in the period when the change in circumstances
occurs. These changes could have a significant impact on the Company’s future earnings.
Income
tax expense was $2,865 for the three and six months ended June 30, compared to $800 for the three and six months ended June 30, 2022.
The annual forecasted effective income tax rate for 2023 is 0%, with a year-to-date effective income tax rate for the six months ended
June 30, 2023, of 0%.
|
X |
- DefinitionThe entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.
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v3.23.2
Commitments and Contingencies
|
6 Months Ended |
Jun. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
Note
15 – Commitments and Contingencies
Insurance
The
Company’s insurance coverage is carried with third-party insurers and includes: (i) general liability insurance covering third-party
exposures; (ii) statutory workers’ compensation insurance; (iv) excess liability insurance above the established primary limits
for general liability and automobile liability insurance; (v) property insurance, which covers the replacement value of real and personal
property and includes business interruption; and (vi) insurance covering our directors and officers for acts related to our business
activities. All coverage is subject to certain limits and deductibles, the terms and conditions of which are common for companies with
similar types of operations.
Legal
Matters
The
Company is not currently subject to any material legal proceedings; however, it could be subject to legal proceedings and claims from
time to time in the ordinary course of its business, or legal proceedings it considered immaterial may in the future become material.
Regardless of the outcome, litigation can, among other things, be time consuming and expensive to resolve, and can divert management
resources.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.23.2
Subsequent Events
|
6 Months Ended |
Jun. 30, 2023 |
Subsequent Events [Abstract] |
|
Subsequent Events |
Note
16 – Subsequent Events
On
July 11, 2023, the Company issued 16,250
shares of Common Stock in consideration of a settlement with an unrelated third party. These shares were issued pursuant to the exemption from registration provided
by Section 4(a)(2) of the Securities Act of 1933, as amended. The Company did not receive any cash proceeds from this issuance.
On August 8, 2023, the Company issued 26,391 shares of Common Stock upon
exercise of an existing warrant on a net-exercise basis. These shares were issued pursuant to the exemption from registration provided
by Section 4(a)(2) and/or 3(a)(9) of the Securities Act of 1933, as amended.
Reverse
Stock Split
On
July 28, 2023 the Company effected a 1-for-20
reverse stock split of its outstanding common stock, please see Note 11 for more details. The Company issued an additional 135 shares of Common Stock for fractional shares.
Amendment
to Armistice SPA
On
July 7, 2023, the Company entered into an Amendment to Securities Purchase Agreement (the “Armistice Amendment”) with Armistice
Capital Markets Ltd. to delete Section 4.12(a) of our March 23, 2023 Securities Purchase Agreement (the “Armistice SPA”)
with Armistice pursuant to which the Company agreed that from March 23, 2023 until 45 days after the effective date of the Resale Registration
Statement (as defined below) the Company would not (i) issue, enter into any agreement to issue or announce the issuance or proposed
issuance of any shares of Common Stock or Common Stock Equivalents or (ii) file any registration statement or any amendment or supplement
thereto, other than the prospectus supplement filed in connection with that offering and the Resale Registration Statement (the “Subsequent
Equity Financing Provision”). In consideration of Armistice’s agreement to enter into the Armistice Amendment and delete
the Subsequent Equity Financing Provision from the Armistice SPA, the Company agreed to pay Armistice a fee a $1,000,000 (the “Armistice
Amendment Fee”) within two days of the closing of this Offering. Additionally, the Company agreed to include a proposal in its
proxy statement for its 2023 Annual Meeting of Stockholders for the purpose of obtaining the approval of the holders of a majority of
our outstanding voting common stock, to effectuate the reduction of the exercise price set forth in Section 2(b) of the Common Stock
Purchase Warrants issued to Armistice on March 27, 2023 (the “Existing Warrants”) to the per unit public offering price of
this Offering, in accordance with Nasdaq Rule 5635(d) (the “Shareholder Approval”) with the recommendation of the Company’s
board of directors that such proposal be approved. The Company also agreed to solicit proxies from its shareholders in connection therewith
in the same manner as all other management proposals in such proxy statement and that all management-appointed proxyholders shall vote
their proxies in favor of such proposal. Further, if the Company does not obtain Shareholder Approval at the first meeting, the Company
will call a meeting every six (6) months thereafter to seek Shareholder Approval until the earlier of the date Shareholder Approval is
obtained or the Existing Warrants are no longer outstanding. Until such approval is obtained, the exercise price of the Existing Warrants
will remain unchanged. The Armistice Amendment Fee was paid concurrent with closing of the August 2023 Public Offering on August 8, 2023.
JAG
Demand Note
On
July 10, 2023, the Company entered into a letter agreement (the “Agreement”) with JAG Multi Investments LLC (“JAG”),
a related party to Andrea Goren, the Company’s CFO, who is a beneficiary of JAG but does not have any control over JAG’s
investment decisions with respect to the Company. In the Agreement, the Company and JAG agreed that (1) JAG would loan the Company $100,000
under a demand promissory note, (2) the date on which JAG can demand payment of principal, fees and any interest under those certain
demand promissory previously issued to JAG by the Company for a total of $500,000, of which JAG may demand payment of $500,000 as of
the date hereof, be extended to September 30, 2023.
July
2023 Standard Merchant Cash Advance Agreement
On
July 19, 2023, the Company entered into a Standard Merchant Cash Advance Agreement with Cedar Advance LLC (“Cedar”) under
which Cedar purchased $543,750 of our receivables for a gross purchase price of $375,000. The Company received net proceeds of $356,250.
Until the purchase price has been repaid, the Company agreed to pay Cedar $19,419.64 per week. If the Company repays the purchase price
within 30-days then the amount payable shall be reduced to $465,000. In addition, the Company granted Cedar a security interest in its
accounts, including deposit accounts and accounts receivable. The Company intends to use the proceeds for working capital and general
corporate purposes.
Notices
from Nasdaq of Failure to Satisfy Continued Listing Rules.
On
July 11, 2023, the Company received a notice from the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market
LLC (“Nasdaq”) that, based upon the Company’s non-compliance with the minimum bid price requirement set forth in Nasdaq
Listing Rule 5550(a)(2) (the “Rule”), as of July 10, 2023, the Nasdaq Hearing Panel (the “Panel”) will consider
such non-compliance in its decision regarding the Company’s continued listing on Nasdaq.
The
Company plans to timely submit to the Panel confirmation of its plan to regain compliance under the Rule, providing similar information
to that presented to the Panel at the Company’s hearing on July 6, 2023.
As
previously disclosed, the Company was granted a 180-day grace period to regain compliance with the Rule through July 10, 2023. The Company
was unable to do so by that date, which resulted in the issuance of the Staff’s notice.
On
July 27, 2023, the Company received a letter from the Panel under which they granted its request for continued listing of Nasdaq subject
to us demonstrating compliance with the Equity Rule as well as Nasdaq Listing Rule 5550(a)(2) (to maintain a minimum bid price of $1;
the “Price Rule”) on or before September 29. 2023. The Panel reserves the right to reconsider the terms of this exception
based on any event, condition or circumstance that exists or develops that would, in the opinion of the Panel, make continued listing
of our securities on Nasdaq inadvisable or unwarranted. In that regard, the Panel advises the Company that it is a requirement during
the exception period that the Company provide prompt notification of any significant events that occur during this time that may affect
its compliance with Nasdaq requirements. This includes, but is not limited to, prompt advance notice of any event that may call into
question its ability to meet the terms of the exception granted.
August
2023 Public Offering
On
August 4, 2023, the Company, entered into securities purchase agreements (the “Purchase Agreements”) with certain institutional
and other investors, pursuant to which the Company agreed to issue and sell to such investors in a public offering (the “Offering”),
1,580,000 units (the “Units”) with each Unit consisting of (i) one share (the “Shares”) of Common Stock of the
Company, and (ii) two common stock purchase warrants (the “Warrants”), each exercisable for one share of Common Stock at
an exercise price of $2.85 per share, for an aggregate of 1,580,000 Shares and Warrants to purchase 3,160,000 shares of Common Stock
being sold in the Offering, at a price of $2.85 per Unit. The securities to be issued in the Offering were offered pursuant to the Company’s
registration statement on Form S-1 (File 333-273174) (the “Registration Statement”), initially filed by the Company with
the Securities and Exchange Commission (the “SEC”) under the Securities Act of 1933, as amended (the “Securities Act”),
on July 7, 2023 and declared effective on August 3, 2023.
The
Company closed the Offering on August 8, 2023, raising gross proceeds of approximately $4.5
million before deducting placement agent fees and other offering expenses payable by the Company. The Company used (i) $2,150,000
of the net proceeds to fund the initial installment of the purchase price required to consummate the acquisition of the Wisconsin
Fertility Institute (net of a $350,000 holdback)
on August 10, 2023; (ii) $1,000,000 of
the net proceeds of this offering to pay Armistice the Armistice Amendment Fee for agreeing to remove the Subsequent Equity
Financing Provision from the Armistice SPA; (iii) $100,000 to
repay that certain 8%
Debenture with a maturity date of February
3, 2024 issued to Peak One Opportunity Fund
LP plus accrued interest and fees of approximately $7,784;
and (iv) $39,849 to
repay that certain 8%
Debenture with a maturity date of February
17, 2024 issued to First Fire Global
Opportunities Fund, LLC, plus accrued interest and fees of approximately $3,127.
The Company intends to use the remaining net proceeds from this offering for working capital and general corporate
purposes.
Also
in connection with the offering, on August 4, 2023, the Company entered into a placement agency agreement (the “Placement
Agency Agreement”) with Maxim Group LLC (the “Placement Agent”), pursuant to which (i) the Placement Agent agreed
to act as placement agent on a “best efforts” basis in connection with the Offering and (ii) the Company agreed to pay
the Placement Agent an aggregate fee equal to 7.0% of the gross proceeds (and 5% for certain investors) raised in the offering and
warrants to purchase up to 110,600 shares of Common Stock at an exercise price of $3.14 (the “Placement Agent
Warrants”). The Placement Agent Warrants (and the shares of Common Stock issuable upon the exercise of the Placement Agent
Warrants) were not registered under the Securities Act and were offered pursuant to an exemption from the registration requirements
of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder.
Wisconsin
Fertility Institute Acquisition
On
August 10, 2023, the Company, through Wood Violet Fertility LLC, a Delaware limited liability company (“Buyer”) and wholly
owned subsidiary of INVO Centers LLC, a Delaware company wholly-owned by INVO, consummated its acquisition of the Wisconsin Fertility
Institute (the “Clinic”) for a combined purchase price of $10 million, of which $2.5 million was paid on the closing date
(net $2,150,000 after a $350,000 holdback) plus assumption of the inter-company loan owed by WFRSA in the amount of $528,756 and the
remaining three installments of $2.5 million each will be paid on the subsequent three anniversaries of closing. The sellers have the
option to take all or a portion of the final three installments in shares of INVO common stock valued at $125.00, $181.80, and $285.80,
for the second, third, and final installments, respectively.
The
Clinic is comprised of (a) a medical practice, Wisconsin Fertility and Reproductive Surgery Associates, S.C., a Wisconsin professional
service corporation d/b/a Wisconsin Fertility Institute (“WFRSA”), and (b) a laboratory services company, Fertility Labs
of Wisconsin, LLC, a Wisconsin limited liability company (“FLOW”). WFRSA owns, operates and manages the Clinic’s fertility
practice that provides direct treatment to patients focused on fertility, gynecology and obstetrics care and surgical procedures, and
employs physicians and other healthcare providers to deliver such services and procedures. FLOW provides WFRSA with related laboratory
services.
INVO
is purchasing the non-medical assets of WFRSA and one hundred percent of FLOW’s membership interests. As reflected in the WFRSA
purchase agreement, the Buyer and WFRSA will enter into a management services agreement pursuant to which WFRSA will outsource all its
non-medical activities to the Buyer.
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v3.23.2
Summary of Significant Accounting Policies (Policies)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Description of Business |
Description
of Business
INVO
Bioscience, Inc. (“INVO” or the “Company”) is a healthcare services fertility company dedicated to expanding
the assisted reproductive technology (“ART”) marketplace by making fertility care accessible and inclusive to people around
the world. The Company’s commercialization strategy is focused on the opening of dedicated “INVO Centers” offering
the INVOcell and IVC procedure (with three centers in North America now operational), the acquisition of US-based, profitable in vitro
fertilization (“IVF”) clinics and the sale and distribution of our technology solution into existing fertility clinics. The
Company’s proprietary technology, INVOcell, is a revolutionary medical device that allows fertilization and early embryo development
to take place in vivo within the woman’s body. This treatment solution is the world’s first intravaginal culture technique
for the incubation of oocytes and sperm during fertilization and early embryo development.
|
Basis of Presentation |
Basis
of Presentation
The
accompanying consolidated financial statements present on a consolidated basis the accounts of the Company and its wholly owned subsidiaries
and controlled affiliates. The Company presents noncontrolling interest within the equity section of its consolidated balance sheets
and the amount of consolidated net income (loss) that is attributable to the Company and to the noncontrolling interest in its consolidated
statement of operations. All significant intercompany accounts and transactions have been eliminated in consolidation.
The
Company uses the equity method of accounting when it owns an interest in an entity whereby it can exert significant influence over but
cannot control the entity’s operations.
The
preparation of the Company’s consolidated financial statements requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated
financial statements and the reported amounts of revenues and expenses during the reporting periods.
The
Company considers events or transactions that have occurred after the consolidated balance sheet date of June 30, 2023, but prior to
the filing of the consolidated financial statements with the SEC in this Quarterly Report on Form 10-Q, to provide additional evidence
relative to certain estimates or to identify matters that require additional disclosure, as applicable. Subsequent events have been evaluated
through the date of the filing of this Quarterly Report on Form 10-Q.
|
Reclassifications |
Reclassifications
Certain amounts in the consolidated financial statements for the prior
year have been reclassified to conform to the current year presentation. These reclassifications had no impact on net earnings, financial
position, or cash flows.
|
Business Segments |
Business
Segments
The
Company operates in one segment and therefore segment information is not presented.
|
Variable Interest Entities |
Variable
Interest Entities
The
Company’s consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries, and variable interest
entities (“VIE”), where the Company is the primary beneficiary under the provisions of ASC 810, Consolidation (“ASC
810”). A VIE must be consolidated by its primary beneficiary when, along with its affiliates and agents, the primary beneficiary
has both: (i) the power to direct the activities that most significantly impact the VIE’s economic performance; and (ii) the obligation
to absorb losses or the right to receive the benefits of the VIE that could potentially be significant to the VIE. The Company reconsiders
whether an entity is still a VIE only upon certain triggering events and continually assesses its consolidated VIEs to determine if it
continues to be the primary beneficiary. See “Note 3 – Variable Interest Entities” for additional information on the
Company’s VIEs.
|
Equity Method Investments |
Equity
Method Investments
Investments
in unconsolidated affiliates, which the Company exerts significant influence but does not control or otherwise consolidate, are accounted
for using the equity method. Equity method investments are initially recorded at cost. These investments are included in investment in
joint ventures in the accompanying consolidated balance sheets. The Company’s share of the profits and losses from these investments
is reported in loss from equity method joint venture in the accompanying consolidated statements of operations. The Company monitors
its investments for other-than-temporary impairment by considering factors such as current economic and market conditions and the operating
performance of the investees and records reductions in carrying values when necessary.
|
Use of Estimates |
Use
of Estimates
In
preparing financial statements in conformity with generally accepted accounting principles, management is required to make estimates
and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at
the date of the financial statements and revenues and expenses during the reported period. Actual results could differ from those estimates.
|
Cash and Cash Equivalents |
Cash
and Cash Equivalents
For
financial statement presentation purposes, the Company considers time deposits, certificates of deposit and all highly liquid investments
with original maturities of three months or less to be cash and cash equivalents. At times, cash and cash equivalents balances exceed
amounts insured by the Federal Deposit Insurance Corporation.
|
Inventory |
Inventory
Inventories
consist of raw materials, work in process and finished goods and are stated at the lower of cost or net realizable value, using the first-in,
first-out method as a cost flow method.
|
Property and Equipment |
Property
and Equipment
The
Company records property and equipment at cost. Property and equipment is depreciated using the straight-line method over the estimated
economic lives of the assets, which are from 3 to 10 years. The Company capitalizes the expenditures for major renewals and improvements
that extend the useful lives of property and equipment. Expenditures for maintenance and repairs are charged to expense as incurred.
The Company reviews the carrying value of long-lived assets for impairment at least annually or whenever events or changes in circumstances
indicate that the carrying amount of an asset may not be recoverable. The recoverability of long-lived assets is measured by a comparison
of its carrying amount to the undiscounted cash flows that the asset or asset group is expected to generate. If such assets are considered
impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the property, if any, exceeds its
fair market value.
|
Long- Lived Assets |
Long-
Lived Assets
Long-lived
assets and certain identifiable assets related to those assets are periodically reviewed for impairment whenever circumstances and situations
change such that there is an indication that the carrying amounts may not be recoverable. If the non-discounted future cash flows of
the asset are less than their carrying amount, their carrying amounts are reduced to fair value and an impairment loss recognized. There
was no impairment recorded during the six months ended June 30, 2023, and 2022.
|
Fair Value of Financial Instruments |
Fair
Value of Financial Instruments
ASC
825-10-50, “Disclosures about Fair Value of Financial Instruments,” requires disclosure of the fair value of certain financial
instruments. The carrying value of cash and cash equivalents, accounts payable and borrowings, as reflected in the balance sheets, approximate
fair value because of the short-term maturity of these instruments.
Effective
January 1, 2008, the Company adopted ASC 820-10, “Fair Value Measurements”, which provides a framework for measuring fair
value under GAAP. ASC 820-10 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability
(an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants
on the measurement date. ASC 820-10 requires that valuation techniques maximize the use of observable inputs and minimize the use of
unobservable inputs.
|
Income Taxes |
Income
Taxes
The
Company is subject to income taxes in the United States and its domestic tax liabilities are subject to the allocation of expenses in
multiple state jurisdictions. The Company uses the asset and liability method to account for income taxes. Under this method, deferred
income tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement
carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured
using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered
or settled. The recoverability of deferred tax assets is evaluated by assessing the adequacy of future expected taxable income from all
sources, including taxable income in prior carryback years, reversal of taxable temporary differences, forecasted operating earnings
and available tax planning strategies. To the extent the Company does not consider it more-likely-than-not that a deferred tax asset
will be recovered, a valuation allowance is established.
|
Concentration of Credit Risk |
Concentration
of Credit Risk
Cash
includes amounts deposited in financial institutions in excess of insurable Federal Deposit Insurance Corporation (“FDIC”)
limits. As of June 30, 2023, the Company did not have cash balances in excess of FDIC limits.
|
Revenue Recognition |
Revenue
Recognition
The
Company recognizes revenue on arrangements in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”).
The core principle of ASC 606 is to recognize revenues when promised goods or services are transferred to customers in an amount that
reflects the consideration to which an entity expects to be entitled for those goods or services ASC 606 requires companies to assess
their contracts to determine the timing and amount of revenue to recognize under the new revenue standard. The model has a five-step
approach:
1. |
Identify the contract with
the customer. |
|
|
2. |
Identify the performance
obligations in the contract. |
|
|
3. |
Determine the total transaction
price. |
|
|
4. |
Allocate the total transaction
price to each performance obligation in the contract. |
|
|
5. |
Recognize as revenue when
(or as) each performance obligation is satisfied. |
Revenue
generated from the sale of INVOcell is typically recognized at the time the product is shipped, at which time the title passes to the
customer, and there are no further performance obligations.
Revenue
generated from clinical and lab services related at the Company’s affiliated INVO Centers is typically recognized at the time the
service is performed.
|
Stock Based Compensation |
Stock
Based Compensation
The
Company accounts for stock-based compensation under the provisions of Accounting Standards Codification (“ASC”) subtopic
718-10, Compensation (“ASC 718-10”). This statement requires the Company to measure the cost of employee services received
in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized over the period
in which the employee is required to provide service or based on performance goals in exchange for the award, which is usually the vesting
period.
|
Loss Per Share |
Loss
Per Share
Basic
loss per share calculations are computed by dividing net loss by the weighted-average number of common shares outstanding. Diluted earnings
per share are computed similar to basic earnings per share except that the denominator is increased to include potentially dilutive securities.
The Company’s diluted loss per share is the same as the basic loss per share for the three and six months ended June 30, 2023,
and 2022, as the inclusion of any potential shares would have had an anti-dilutive effect due to the Company generating a loss.
Schedule of Earnings Per Share Basic and Diluted
| |
| | |
| | |
| | |
| |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net loss (numerator) | |
$ | (2,240,511 | ) | |
| (2,801,541 | ) | |
| (4,791,390 | ) | |
| (5,575,853 | ) |
Basic and diluted weighted-average number of common shares outstanding (denominator) | |
| 732,255 | | |
| 605,760 | | |
| 677,684 | | |
| 604,123 | |
Basic weighted-average number of common shares outstanding (denominator) | |
| 732,255 | | |
| 605,760 | | |
| 677,684 | | |
| 604,123 | |
Basic and diluted net loss per common share | |
| (3.06 | ) | |
| (4.62 | ) | |
| (7.07 | ) | |
| (9.23 | ) |
Basic net loss per common share | |
| (3.06 | ) | |
| (4.62 | ) | |
| (7.07 | ) | |
| (9.23 | ) |
The
Company has excluded the following dilutive securities from the calculation of fully diluted shares outstanding because the result would
have been anti-dilutive:
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share
| |
| | |
| |
| |
As of June 30, | |
| |
2023 | | |
2022 | |
Options | |
| 121,255 | | |
| 74,480 | |
Convertible notes and interest | |
| 55,120 | | |
| - | |
Unit purchase options and warrants | |
| 348,151 | | |
| 13,008 | |
Total | |
| 524,526 | | |
| 87,488 | |
|
Recently Adopted Accounting Pronouncements |
Recently
Adopted Accounting Pronouncements
The
Company has reviewed all recently issued, but not yet effective, accounting pronouncements, and does not believe the future adoption
of any such pronouncements will have a material impact on its financial condition or the results of its operations.
|
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v3.23.2
Summary of Significant Accounting Policies (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Schedule of Earnings Per Share Basic and Diluted |
Schedule of Earnings Per Share Basic and Diluted
| |
| | |
| | |
| | |
| |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net loss (numerator) | |
$ | (2,240,511 | ) | |
| (2,801,541 | ) | |
| (4,791,390 | ) | |
| (5,575,853 | ) |
Basic and diluted weighted-average number of common shares outstanding (denominator) | |
| 732,255 | | |
| 605,760 | | |
| 677,684 | | |
| 604,123 | |
Basic weighted-average number of common shares outstanding (denominator) | |
| 732,255 | | |
| 605,760 | | |
| 677,684 | | |
| 604,123 | |
Basic and diluted net loss per common share | |
| (3.06 | ) | |
| (4.62 | ) | |
| (7.07 | ) | |
| (9.23 | ) |
Basic net loss per common share | |
| (3.06 | ) | |
| (4.62 | ) | |
| (7.07 | ) | |
| (9.23 | ) |
|
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share |
The
Company has excluded the following dilutive securities from the calculation of fully diluted shares outstanding because the result would
have been anti-dilutive:
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share
| |
| | |
| |
| |
As of June 30, | |
| |
2023 | | |
2022 | |
Options | |
| 121,255 | | |
| 74,480 | |
Convertible notes and interest | |
| 55,120 | | |
| - | |
Unit purchase options and warrants | |
| 348,151 | | |
| 13,008 | |
Total | |
| 524,526 | | |
| 87,488 | |
|
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v3.23.2
Variable Interest Entities (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Schedule of Investments in Unconsolidated Variable Interest Entities |
The
following table summarizes our investments in unconsolidated VIEs:
Schedule of Investments in Unconsolidated Variable Interest Entities
| |
| |
Carrying Value as of | |
| |
Location | |
Percentage Ownership | | |
June 30, 2023 | | |
December 31, 2022 | |
HRCFG INVO, LLC | |
Alabama, United States | |
| 50 | % | |
$ | 1,023,346 | | |
| 1,106,905 | |
Positib Fertility, S.A. de C.V. | |
Mexico | |
| 33 | % | |
| 109,019 | | |
| 130,960 | |
Total investment in unconsolidated VIEs | | | |
$ | 1,132,365 | | |
| 1,237,865 | |
|
Schedule of Earnings from Investments in Unconsolidated Variable Interest Entities |
Earnings
from investments in unconsolidated VIEs were as follows:
Schedule of Earnings from Investments in Unconsolidated Variable Interest Entities
| |
| | |
| | |
| | |
| |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
HRCFG INVO, LLC | |
$ | 19,474 | | |
$ | (104,255 | ) | |
$ | 805 | | |
$ | (159,175 | ) |
Positib Fertility, S.A. de C.V. | |
| (15,686 | ) | |
| (13,723 | ) | |
| (24,752 | ) | |
| (29,920 | ) |
Total earnings from unconsolidated VIEs | |
| 3,788 | | |
| (117,978 | ) | |
| (23,947 | ) | |
| (189,095 | ) |
|
Schedule of Financial Information of Investments in Unconsolidated Variable Interest Entities |
The
following tables summarize the combined unaudited financial information of our unconsolidated VIEs:
Schedule of Financial Information of Investments in Unconsolidated Variable Interest Entities
| |
| | |
| | |
| | |
| |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Statements of operations: | |
| | |
| | |
| | |
| |
Operating revenue | |
$ | 458,069 | | |
$ | 166,477 | | |
$ | 807,396 | | |
$ | 336,312 | |
Operating expenses | |
| (466,184 | ) | |
| (415,665 | ) | |
| (880,050 | ) | |
| (744,421 | ) |
Net loss | |
| (8,115 | ) | |
| (249,188 | ) | |
| (72,654 | ) | |
| (408,109 | ) |
| |
| | |
| |
| |
June 30, 2023 | | |
December 31, 2022 | |
Balance sheets: | |
| | | |
| | |
Current assets | |
$ | 416,948 | | |
| 261,477 | |
Long-term assets | |
| 1,057,010 | | |
| 1,094,490 | |
Current liabilities | |
| (513,709 | ) | |
| (396,619 | ) |
Long-term liabilities | |
| (121,773 | ) | |
| (107,374 | ) |
Net assets | |
$ | 838,476 | | |
| 851,974 | |
|
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v3.23.2
Agreements and Transactions with VIE’s (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Agreements And Transactions With Vies |
|
Summary of Transaction with Variable Interest Entities |
The
following table summarizes the Company’s transactions with VIEs:
Summary of Transaction with Variable Interest Entities
| |
| | |
| | |
| | |
| |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Bloom Invo, LLC | |
| | | |
| | | |
| | | |
| | |
INVOcell revenue | |
$ | 6,000 | | |
$ | - | | |
$ | 10,500 | | |
$ | - | |
Unconsolidated VIEs | |
| | | |
| | | |
| | | |
| | |
INVOcell revenue | |
$ | 6,750 | | |
$ | 9,000 | | |
$ | 9,750 | | |
$ | 16,500 | |
|
Summary of Balances with Variable Interest Entities |
The
Company had balances with VIEs as follows:
Summary of Balances with Variable Interest Entities
| |
| | |
| |
| |
June 30, 2023 | | |
December 31, 2022 | |
Bloom Invo, LLC | |
| | | |
| | |
Accounts receivable | |
$ | 12,000 | | |
| 13,500 | |
Notes payable | |
| 472,839 | | |
| 468,031 | |
Unconsolidated VIEs | |
| | | |
| | |
Accounts receivable | |
$ | 34,935 | | |
| 46,310 | |
|
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v3.23.2
Inventory (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Inventory Disclosure [Abstract] |
|
Schedule of Inventory |
Components
of inventory are:
Schedule of Inventory
| |
June 30, 2023 | | |
December 31, 2022 | |
Raw materials | |
$ | 62,745 | | |
$ | 68,723 | |
Finished goods | |
| 217,273 | | |
| 194,879 | |
Total inventory | |
$ | 280,018 | | |
$ | 263,602 | |
|
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v3.23.2
Property and Equipment (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Schedule of Estimated Useful Lives of Property and Equipment |
The
estimated useful lives and accumulated depreciation for equipment are as follows as of June 30, 2023, and December 31, 2022:
Schedule of Estimated Useful Lives of Property and Equipment
|
|
Estimated
Useful Life |
|
Manufacturing equipment |
|
6 to 10 years |
|
Medical equipment |
|
7 to 10 years |
|
Office equipment |
|
3 to 7 years |
|
|
Schedule of Property and Equipment |
Schedule of Property and Equipment
| |
| | |
| |
| |
June 30, 2023 | | |
December 31, 2022 | |
Manufacturing equipment | |
$ | 132,513 | | |
$ | 132,513 | |
Medical equipment | |
| 283,065 | | |
| 283,065 | |
Office equipment | |
| 77,601 | | |
| 77,601 | |
Leasehold improvements | |
| 358,322 | | |
| 96,817 | |
Less: accumulated depreciation | |
| (192,059 | ) | |
| (153,267 | ) |
Total equipment, net | |
$ | 659,442 | | |
$ | 436,729 | |
|
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v3.23.2
Leases (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Leases |
|
Schedule of Lease Components |
As
of June 30, 2023, the Company’s lease components included in the consolidated balance sheet were as follows:
Schedule of Lease Components
| |
| |
| |
Lease component | |
Balance sheet classification | |
June 30, 2023 | |
Assets | |
| |
| | |
ROU assets – operating lease | |
Other assets | |
$ | 4,004,962 | |
Total ROU assets | |
| |
$ | 4,004,962 | |
| |
| |
| | |
Liabilities | |
| |
| | |
Current operating lease liability | |
Current liabilities | |
$ | 227,026 | |
Long-term operating lease liability | |
Other liabilities | |
| 3,873,289 | |
Total lease liabilities | |
| |
$ | 4,100,315 | |
|
Schedule of Future Minimum Lease Payments |
Future
minimum lease payments as of June 30, 2023 were as follows:
Schedule of Future Minimum Lease Payments
| |
| | |
2023 | |
| 156,465 | |
2024 | |
| 392,869 | |
2025 | |
| 392,688 | |
2026 | |
| 401,581 | |
2027 and beyond | |
| 4,197,510 | |
Total future minimum lease payments | |
$ | 5,541,113 | |
Less: Interest | |
| (1,440,798 | ) |
Total operating lease liabilities | |
$ | 4,100,315 | |
|
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v3.23.2
Notes Payable (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Debt Disclosure [Abstract] |
|
Schedule of Notes Payable |
Notes
payables consisted of the following:
Schedule
of Notes Payable
| |
| | |
| |
| |
June 30, 2023 | | |
December 31, 2022 | |
Less debt discount | |
| (285,961 | ) | |
| (107,356 | ) |
Related party demand notes with a 10% financing fee. 10% annual interest starting January 31, 2023. Notes are callable starting September 30, 2023 | |
$ | 770,000 | | |
$ | 770,000 | |
Convertible notes. 10% annual interest. Conversion price of $10.00-$12.00 | |
| 410,000 | | |
| 100,000 | |
Convertible debentures. 8% interest. Conversion price of $10.40 | |
| 139,849 | | |
| - | |
Less debt discount | |
| (285,961 | ) | |
| (107,356 | ) |
Total, net of discount | |
$ | 1,033,888 | | |
$ | 762,644 | |
|
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v3.23.2
Equity-Based Compensation (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
Schedule of Stock Options Activity |
The
following table sets forth the activity of the options to purchase Common Stock under the 2019 Plan.
Schedule of Stock Options Activity
| |
Number of Shares | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
Outstanding as of December 31, 2022 | |
| 64,850 | | |
$ | 68.00 | | |
$ | - | |
Granted | |
| 59,048 | | |
| 7.74 | | |
| - | |
Exercised | |
| (297 | ) | |
| 8.00 | | |
| - | |
Canceled | |
| (2,346 | ) | |
| 72.38 | | |
| - | |
Balance as of June 30, 2023 | |
| 121,255 | | |
$ | 2.10 | | |
$ | - | |
Exercisable as of June 30, 2023 | |
| 71,251 | | |
$ | 62.42 | | |
$ | - | |
|
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions |
The
fair value of each option granted is estimated as of the grant date using the Black-Scholes option pricing model with the following assumptions:
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions
| |
| Six months ended June 30, |
| |
| 2023 | | |
| 2022 | |
Risk-free interest rate range | |
| 3.6-3.69 % | | |
| 1.6 to 1.9 % | |
Expected life of option-years | |
| 5-5.63 | | |
| 5.25 to 5.75 | |
Expected stock price volatility | |
| 106.6-114.9 % | | |
| 110.4 to 113.2 % | |
Expected dividend yield | |
| - | % | |
| - | % |
|
Schedule of Share Based Payments Arrangements Options Exercised and Options Vested |
Schedule of Share Based Payments Arrangements Options Exercised and Options Vested
| |
Total Intrinsic Value of Options Exercised | | |
Total Fair Value of Options Vested | |
Year ended December 31, 2022 | |
$ | - | | |
$ | 1,616,401 | |
Six months ended June 30, 2023 | |
$ | - | | |
$ | 654,925 | |
|
Schedule of Aggregate Restricted Stock Awards and Restricted Stock Unit Activity |
The
following table summarizes the Company’s restricted stock awards activity under the 2019 Plan during the six months ended June
30, 2023:
Schedule of Aggregate Restricted Stock Awards and Restricted Stock Unit Activity
| |
Number of Unvested Shares | | |
Weighted Average Grant Date Fair Value | | |
Aggregate Value of Shares | |
| |
| | |
| | |
| |
Balance as of December 31, 2022 | |
| 3,533 | | |
$ | 8.40 | | |
$ | 29,949 | |
Granted | |
| 13,272 | | |
| 8.88 | | |
| 97,172 | |
Vested | |
| (16,505 | ) | |
| 18.82 | | |
| 286,597 | |
Forfeitures | |
| - | | |
| - | | |
| - | |
Balance as of June 30, 2023 | |
| 300 | | |
| 18.42 | | |
| 5,525 | |
|
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v3.23.2
Unit Purchase Options and Warrants (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Unit Purchase Options And Warrants |
|
Schedule of Unit Purchase Stock Options Activity |
The
following table sets forth the activity of unit purchase options:
Schedule
of Unit Purchase Stock Options Activity
| |
Number of Unit Purchase Options | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
Outstanding as of December 31, 2022 | |
$ | 4,649 | | |
$ | 64.00 | | |
$ | - | |
Granted | |
| - | | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | | |
| - | |
Canceled | |
| - | | |
| - | | |
| - | |
Balance as of June 30, 2023 | |
$ | 4,649 | | |
$ | 64.00 | | |
$ | - | |
|
Schedule of Warrants Activity |
The
following table sets forth the activity of warrants:
Schedule
of Warrants Activity
| |
Number of Warrants | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
Outstanding as of December 31, 2022 | |
| 25,864 | | |
$ | 30.20 | | |
$ | - | |
Granted | |
| 432,618 | | |
| 12.60 | | |
| - | |
Exercised | |
| (115,000 | ) | |
| 0.20 | | |
| - | |
Canceled | |
| - | | |
| - | | |
| - | |
Balance as of June 30, 2023 | |
| 378,849 | | |
$ | 20.41 | | |
$ | - | |
|
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v3.23.2
Schedule of Earnings Per Share Basic and Diluted (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Accounting Policies [Abstract] |
|
|
|
|
Net loss (numerator) |
$ (2,240,511)
|
$ (2,801,541)
|
$ (4,791,390)
|
$ (5,575,853)
|
Basic weighted-average number of common shares outstanding (denominator) |
732,255
|
605,760
|
677,684
|
604,123
|
Diluted weighted-average number of common shares outstanding (denominator) |
732,255
|
605,760
|
677,684
|
604,123
|
Basic net loss per common share |
$ (3.06)
|
$ (4.62)
|
$ (7.07)
|
$ (9.23)
|
Diluted net loss per common share |
$ (3.06)
|
$ (4.62)
|
$ (7.07)
|
$ (9.23)
|
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Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares
|
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
524,526
|
87,488
|
Share-Based Payment Arrangement, Option [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
121,255
|
74,480
|
Convertible Notes and Interest [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
55,120
|
|
Unit Purchase Option and Warrants [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
348,151
|
13,008
|
X |
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v3.23.2
Liquidity (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
|
|
|
|
Net loss |
$ 2,240,511
|
$ 2,801,541
|
$ 4,791,390
|
$ 5,575,853
|
|
Accumulated deficit |
$ 54,574,923
|
|
54,574,923
|
|
$ 49,783,533
|
Net income loss related to non cash expenses |
|
|
1,400,000
|
1,600,000
|
|
Proceeds from sale of common stock |
|
|
$ 2,728,938
|
$ 315,000
|
|
Common stock per share |
$ 0.0001
|
|
$ 0.0001
|
|
$ 0.0001
|
Proceeds from issuance of convertible preferred stock |
|
|
$ 700,000
|
|
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.2
Schedule of Investments in Unconsolidated Variable Interest Entities (Details) - USD ($)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Investment in unconsolidated variable interest entities |
$ 1,132,365
|
$ 1,237,865
|
HRCFG INVO, LLC [Member] |
|
|
Ownership percentage |
50.00%
|
|
Investment in unconsolidated variable interest entities |
$ 1,023,346
|
1,106,905
|
Positib Fertility S.A. de C.V. [Member] |
|
|
Ownership percentage |
33.00%
|
|
Investment in unconsolidated variable interest entities |
$ 109,019
|
$ 130,960
|
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|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] |
|
|
|
|
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$ 3,788
|
$ (117,978)
|
$ (23,947)
|
$ (189,095)
|
HRCFG INVO, LLC [Member] |
|
|
|
|
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] |
|
|
|
|
Total earnings from unconsolidated VIEs |
19,474
|
(104,255)
|
805
|
(159,175)
|
Positib Fertility S.A. de C.V. [Member] |
|
|
|
|
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] |
|
|
|
|
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$ (15,686)
|
$ (13,723)
|
$ (24,752)
|
$ (29,920)
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v3.23.2
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|
3 Months Ended |
6 Months Ended |
|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] |
|
|
|
|
|
Operating revenue |
$ (2,065,977)
|
$ (2,681,821)
|
$ (4,372,397)
|
$ (5,382,759)
|
|
Net loss |
(2,240,511)
|
(2,801,541)
|
(4,791,390)
|
(5,575,853)
|
|
Current assets |
842,125
|
|
842,125
|
|
$ 621,087
|
Current liabilities |
(4,469,150)
|
|
(4,469,150)
|
|
(3,409,424)
|
Variable Interest Entity, Primary Beneficiary [Member] |
|
|
|
|
|
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] |
|
|
|
|
|
Operating revenue |
458,069
|
166,477
|
807,396
|
336,312
|
|
Operating expenses |
(466,184)
|
(415,665)
|
(880,050)
|
(744,421)
|
|
Net loss |
(8,115)
|
$ (249,188)
|
(72,654)
|
$ (408,109)
|
|
Current assets |
416,948
|
|
416,948
|
|
261,477
|
Long-term assets |
1,057,010
|
|
1,057,010
|
|
1,094,490
|
Current liabilities |
(513,709)
|
|
(513,709)
|
|
(396,619)
|
Long-term liabilities |
(121,773)
|
|
(121,773)
|
|
(107,374)
|
Net assets |
$ 838,476
|
|
$ 838,476
|
|
$ 851,974
|
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v3.23.2
Variable Interest Entities (Details Narrative) - USD ($)
|
|
|
3 Months Ended |
6 Months Ended |
Jun. 28, 2021 |
Mar. 10, 2021 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Variable interest entity ownership, percentage |
150.00%
|
|
|
|
|
|
Net loss |
|
|
$ (2,240,511)
|
$ (2,801,541)
|
$ (4,791,390)
|
$ (5,575,853)
|
Georgia JV [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Investment |
|
|
900,000
|
|
900,000
|
|
Notes receivable related parties |
|
|
500,000
|
|
500,000
|
|
Net loss |
|
|
|
|
100,000
|
300,000
|
Minority interest |
|
|
0
|
|
0
|
|
Alabama JV [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Investment |
|
|
1,600,000
|
|
1,600,000
|
|
Net loss |
|
|
|
|
2,000
|
300,000
|
Gain from equity investment |
|
|
|
|
805,000
|
|
Loss from equity investment |
|
|
|
|
|
200,000
|
Mexico JV [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Investment |
|
|
$ 100,000
|
|
100,000
|
|
Net loss |
|
|
|
|
74,000
|
90,000
|
Loss from equity investment |
|
|
|
|
$ 24,000
|
$ 30,000
|
Bloom INVO LLC [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Variable interest entity commitment contribution |
$ 1,200,000
|
|
|
|
|
|
Variable interest entity units issued |
1,200
|
|
|
|
|
|
Bloom INVO LLC [Member] | Bloom Agreement [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Variable interest entity commitment contribution |
$ 800,000
|
|
|
|
|
|
Variable interest entity units issued |
800
|
|
|
|
|
|
Alabama JV [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Variable interest entity ownership, percentage |
|
50.00%
|
|
|
|
|
X |
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3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Bloom INVO LLC [Member] |
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$ 10,500
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$ 9,000
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$ 9,750
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$ 16,500
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$ 762,644
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v3.23.2
Schedule of Property and Equipment (Details) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
Less: accumulated depreciation |
$ (192,059)
|
$ (153,267)
|
Total equipment, net |
659,442
|
436,729
|
Manufacturing Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Leasehold improvements |
132,513
|
132,513
|
Medical Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Leasehold improvements |
283,065
|
283,065
|
Office Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Leasehold improvements |
77,601
|
77,601
|
Leasehold Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Leasehold improvements |
$ 358,322
|
$ 96,817
|
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v3.23.2
Schedule of Lease Components (Details) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Assets |
|
|
ROU assets – operating lease |
$ 4,004,962
|
$ 1,808,034
|
Total ROU assets |
4,004,962
|
|
Liabilities |
|
|
Current operating lease liability |
227,026
|
231,604
|
Long-term operating lease liability |
3,873,289
|
$ 1,669,954
|
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|
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v3.23.2
Schedule of Future Minimum Lease Payments (Details)
|
Jun. 30, 2023
USD ($)
|
Leases |
|
2023 |
$ 156,465
|
2024 |
392,869
|
2025 |
392,688
|
2026 |
401,581
|
2027 and beyond |
4,197,510
|
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5,541,113
|
Less: Interest |
(1,440,798)
|
Total operating lease liabilities |
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|
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v3.23.2
Schedule of Notes Payable (Details) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Short-Term Debt [Line Items] |
|
|
Less debt discount |
$ (285,961)
|
$ (107,356)
|
Total, net of discount |
1,033,888
|
762,644
|
Related Party Demand Notes [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Related party demand notes |
770,000
|
770,000
|
Demand Notes [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Related party demand notes |
410,000
|
100,000
|
Convertible Debentures [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Related party demand notes |
$ 139,849
|
|
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v3.23.2
Notes Payable (Details Narrative) - USD ($)
|
|
|
|
|
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
|
Feb. 17, 2023 |
Feb. 03, 2023 |
Dec. 29, 2022 |
Dec. 13, 2022 |
Dec. 02, 2022 |
Nov. 29, 2022 |
Mar. 31, 2023 |
Jan. 31, 2023 |
Dec. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Aug. 08, 2023 |
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Warrant purchase of common stock, shares |
|
|
17,500
|
|
|
|
|
|
|
|
|
|
Share price |
$ 10.40
|
$ 10.40
|
|
|
|
|
|
|
|
|
|
|
Proceeds from convertible debt |
|
|
|
|
|
|
$ 410,000
|
$ 410,000
|
$ 200,000
|
|
|
|
Debt Instrument, Description |
|
|
|
|
|
|
|
|
These notes accrue 10% annual interest accrues from the date of issuance. These notes are callable
with 10 days prior written notice. At maturity, the Company agreed to pay outstanding principal, a 10% financing fee and accrued interest
|
|
|
|
Cash and conversion of debt |
|
|
|
|
|
|
|
|
$ 310,000
|
|
|
|
Debt instrument, convertible, conversion price |
|
|
|
|
|
|
|
|
|
$ 12.00
|
|
|
Conversion of stock, shares issued |
|
|
|
|
|
|
|
|
|
19,375
|
|
|
Amortization of debt discount |
|
|
|
|
|
|
|
|
|
$ 301,098
|
|
|
Debt instrument interest rate stated percentage |
|
|
|
|
|
|
|
|
|
10.00%
|
|
|
Maturity date |
|
|
|
|
|
|
|
|
|
Dec. 31, 2023
|
|
|
Principal amount to be redeemed |
8.00%
|
8.00%
|
|
|
|
|
|
|
|
|
|
|
Percentage of debentures outstanding |
50.00%
|
50.00%
|
|
|
|
|
|
|
|
|
|
|
February Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Share price |
$ 450,000
|
$ 450,000
|
|
|
|
|
|
|
|
|
|
|
Proceeds from registered direct offering |
$ 2,000,000
|
$ 2,000,000
|
|
|
|
|
|
|
|
|
|
|
Registered Direct Offering [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from registered direct offering |
$ 360,151
|
360,151
|
|
|
|
|
|
|
|
|
|
|
February Debentures [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from registered direct offering |
|
$ 383,879
|
|
|
|
|
|
|
|
|
|
|
Debentures outstanding |
|
|
|
|
|
|
|
|
|
$ 139,849
|
|
|
February Debentures [Member] | Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Debentures outstanding |
|
|
|
|
|
|
|
|
|
|
|
$ 139,849
|
Convertible Debt [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Interest costs incurred |
|
|
|
|
|
|
|
|
|
$ 17,456
|
|
|
Note Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Debt instrument term |
|
|
|
|
|
|
|
|
|
5 years
|
|
|
Jan And March 2023 Convertible Notes [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Recoginzed amount of debt discount |
|
|
|
|
|
|
|
|
|
$ 132,183
|
|
|
Amortization of debt discount |
|
|
|
|
|
|
|
|
|
59,238
|
|
|
Remaining balance of debt discount |
|
|
|
|
|
|
|
|
|
72,945
|
|
|
February Debentures [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Interest costs incurred |
|
|
|
|
|
|
|
|
|
8,444
|
|
|
Principal amount to be redeemed |
105.00%
|
105.00%
|
|
|
|
|
|
|
|
|
|
|
February Debentures [Member] | February Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Debt instrument, face amount |
$ 500,000
|
$ 500,000
|
|
|
|
|
|
|
|
|
|
|
February Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase shares |
12,500
|
12,500
|
|
|
|
|
|
|
|
|
|
|
Warrant strike price |
$ 2.85
|
|
|
|
|
|
|
|
|
|
|
|
February Commitment Shares [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase shares |
4,167
|
4,167
|
|
|
|
|
|
|
|
|
|
|
February 2023 Convertible Notes [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Recoginzed amount of debt discount |
|
|
|
|
|
|
|
|
|
291,207
|
|
|
Amortization of debt discount |
|
|
|
|
|
|
|
|
|
86,642
|
|
|
Remaining balance of debt discount |
|
|
|
|
|
|
|
|
|
$ 213,016
|
|
|
August Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Warrant strike price |
$ 2.85
|
$ 2.85
|
|
|
|
|
|
|
|
|
|
|
February Investors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase shares |
65,790
|
65,790
|
|
|
|
|
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Share price |
|
|
|
|
|
|
|
|
|
$ 20.00
|
|
|
Proceeds from convertible debt |
|
|
|
|
|
|
$ 135,000
|
$ 275,000
|
100,000
|
|
|
|
Debt instrument, convertible, conversion price |
|
|
|
|
|
|
|
|
|
$ 10.00
|
|
|
Warrant strike price |
$ 15.00
|
$ 15.00
|
|
|
|
|
|
|
|
|
|
|
Chief Executive Officer [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from convertible debt |
|
|
|
$ 25,000
|
$ 15,000
|
$ 60,000
|
|
|
100,000
|
|
|
|
Chief Financial Officer [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from convertible debt |
|
|
|
$ 25,000
|
|
$ 75,000
|
|
|
100,000
|
|
|
|
Interest costs incurred |
|
|
|
|
|
|
|
|
|
$ 42,758
|
|
|
JAG Multi Investments LLC [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of demand notes, related party |
|
|
$ 100,000
|
|
|
|
|
|
$ 500,000
|
|
|
|
Interest rate percentage description |
|
|
|
|
|
|
|
|
The JAG Notes accrue 10% annual interest from the date of
issuance. At maturity, the Company agreed to pay outstanding principal, a 10% financing fee and accrued interest.
|
|
|
|
Warrants exercises term |
|
|
|
|
|
|
|
|
5 years
|
|
|
|
Share price |
|
|
|
|
|
|
|
|
$ 10.00
|
|
|
|
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v3.23.2
Stockholders’ Equity (Details Narrative) - USD ($)
|
|
|
|
|
|
1 Months Ended |
6 Months Ended |
|
|
Jul. 28, 2023 |
Mar. 27, 2023 |
Mar. 23, 2023 |
Feb. 17, 2023 |
Feb. 03, 2023 |
May 31, 2023 |
Mar. 31, 2023 |
Feb. 28, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jul. 27, 2023 |
Dec. 31, 2022 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, shares authorized |
|
|
|
|
|
|
|
|
6,250,000
|
|
|
6,250,000
|
Purchase of shares of common stock description |
|
|
|
|
(i) in a minimum amount of not less
than $25,000 and (ii) in a maximum amount of up to the lesser of (a) $750,000 or (b) 200% of the Company’s average daily trading
value of the Common Stock
|
|
|
|
|
|
|
|
Number of common stock upon exercise of options |
|
|
|
|
|
|
|
|
297
|
|
|
|
Stock issued during period value for services |
|
|
|
|
|
|
|
|
$ 244,176
|
$ 116,766
|
|
|
Proceeds from options exercised |
|
|
|
|
|
|
|
|
2,375
|
|
|
|
Number of new stock issued during the period value |
|
|
|
|
|
|
|
|
2,728,938
|
315,000
|
|
|
Proceeds from sale of common stock |
|
|
|
|
|
|
|
|
$ 2,728,938
|
$ 315,000
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Number of new stock issued during the period |
|
|
|
|
|
|
|
|
184,000
|
4,731
|
|
|
Exercise price |
|
|
|
$ 15.00
|
$ 15.00
|
|
|
|
|
|
|
|
Number of common stock upon exercise of options |
|
|
|
|
|
|
|
|
297
|
|
|
|
Number of sahres issued for services |
|
|
|
|
|
|
|
|
25,817
|
2,750
|
|
|
Stock issued during period value for services |
|
|
|
|
|
|
|
|
$ 3
|
|
|
|
Number of new stock issued during the period value |
|
|
|
|
|
|
|
|
$ 18
|
|
|
|
February Investors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Number of new stock issued during the period |
|
|
|
|
7,500
|
|
|
|
|
|
|
|
Pre-funded warrants purchase |
|
|
|
65,790
|
65,790
|
|
|
|
|
|
|
|
Equity Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from sale of shares |
|
|
|
|
$ 10,000,000.0
|
|
|
|
|
|
|
|
Number of new stock issued during the period |
|
|
|
|
|
|
|
7,500
|
|
|
|
|
Number of new stock issued during the period value |
|
|
|
|
|
|
|
$ 93,000
|
|
|
|
|
March Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Number of new stock issued during the period |
|
|
69,000
|
|
|
|
|
|
|
|
|
|
Pre-funded warrants purchase |
|
|
115,000
|
|
|
|
|
|
|
|
|
|
Exercise price |
|
|
$ 0.20
|
|
|
|
|
|
|
|
|
|
Number of common stock upon exercise of options |
|
|
276,000
|
|
|
|
|
|
|
|
|
|
Exercise price |
|
|
$ 12.60
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance initial public offering |
|
$ 3,000,000
|
|
|
|
|
|
|
|
|
|
|
Additional gross proceeds from warrants exercises |
|
$ 3,500,000
|
|
|
|
|
|
|
|
|
|
|
February Debentures [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Number of new stock issued during the period |
|
|
|
|
|
|
|
4,167
|
|
|
|
|
Proceeds to repay portion of february debentures |
|
|
|
|
383,879
|
|
|
|
|
|
|
|
Number of new stock issued during the period value |
|
|
|
|
|
|
|
$ 56,313
|
|
|
|
|
Registered Direct Offering [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds to repay portion of february debentures |
|
|
|
$ 360,151
|
$ 360,151
|
|
|
|
|
|
|
|
Proceeds from sale of common stock |
|
|
|
|
|
|
$ 2,700,000
|
|
|
|
|
|
Registered Direct Offering [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Number of new stock issued during the period |
|
|
|
|
|
|
69,000
|
|
|
|
|
|
Common Stock Consultants in Consideration [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Number of sahres issued for services |
|
|
|
|
|
6,115
|
|
|
|
|
|
|
Board of Directors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, shares authorized |
125,000,000
|
|
|
|
|
|
|
|
|
|
6,250,000
|
|
Reverse stock split |
On July 26,
2023, the Company filed a certificate of change (with an effective date of July 28, 2023) with the Nevada Secretary of State pursuant
to Nevada Revised Statutes 78.209 to effectuate a 1-for-20 reverse stock split of its outstanding common stock.
|
|
|
|
|
|
|
|
|
|
|
|
Employees and Directors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Number of common stock upon exercise of options |
|
|
|
|
|
|
|
|
297
|
|
|
|
Employees and Directors [Member] | 2019 Stock Incentive Plan [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Number of sahres issued for services |
|
|
|
|
|
|
|
|
3,994
|
|
|
|
Stock issued during period value for services |
|
|
|
|
|
|
|
|
$ 51,565
|
|
|
|
Consultant [Member] | 2019 Stock Incentive Plan [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Number of sahres issued for services |
|
|
|
|
|
|
|
|
12,202
|
|
|
|
Stock issued during period value for services |
|
|
|
|
|
|
|
|
$ 106,176
|
|
|
|
Common Stock Consultants in Consideration [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period value for services |
|
|
|
|
|
$ 45,000
|
|
|
|
|
|
|
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- DefinitionLine items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.
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v3.23.2
Schedule of Stock Options Activity (Details)
|
6 Months Ended |
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Equity [Abstract] |
|
Number of shares, options outstanding, beginning balance | shares |
64,850
|
Weighted average exercise price, outstanding, beginning balance |
$ 68.00
|
Aggregate intrinsic value, outstanding, beginning balance | $ |
|
Number of shares, options outstanding, granted | shares |
59,048
|
Weighted average exercise price, options outstanding, granted |
$ 7.74
|
Aggregate intrinsic value, granted | $ |
|
Number of shares, options outstanding, exercised | shares |
(297)
|
Weighted average exercise price, options outstanding, exercised |
$ 8.00
|
Aggregate intrinsic value, exercised | $ |
|
Number of shares, options outstanding, canceled | shares |
(2,346)
|
Weighted average exercise price, outstanding, canceled |
$ 72.38
|
Aggregate intrinsic value, canceled |
|
Number of shares, options outstanding, ending balance | shares |
121,255
|
Weighted average exercise price, outstanding, ending balance |
$ 2.10
|
Aggregate intrinsic value, outstanding, ending balance | $ |
|
Number of shares, options exercisable, ending balance | shares |
71,251
|
Weighted average exercise price, options exercisable, ending balance |
$ 62.42
|
Aggregate intrinsic value, options exercisable, ending balance | $ |
|
X |
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v3.23.2
Schedule of Aggregate Restricted Stock Awards and Restricted Stock Unit Activity (Details) - Restricted Stock [Member] - 2019 Stock Incentive Plan [Member]
|
6 Months Ended |
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of unvested shares, beginning balance | shares |
3,533
|
Weighted averag exercise price, beginning balance | $ / shares |
$ 8.40
|
Aggregate value of unvested shares, beginning balance | $ |
$ 29,949
|
Number of unvested shares, granted | shares |
13,272
|
Weighted average exercise price, granted | $ / shares |
$ 8.88
|
Aggregate value of unvested shares, granted | $ |
$ 97,172
|
Number of unvested shares, vested | shares |
(16,505)
|
Weighted average exercise price, vested | $ / shares |
$ 18.82
|
Aggregate value of unvested shares, vested | $ |
$ 286,597
|
Number of unvested shares, forfeitures | shares |
|
Weighted average exercise price, forfeitures | $ / shares |
|
Aggregate value of unvested shares, forfeitures | $ |
|
Number of unvested shares, ending balance | shares |
300
|
Weighted average exercise price, ending balance | $ / shares |
$ 18.42
|
Aggregate value of unvested shares, ending balance | $ |
$ 5,525
|
X |
- DefinitionAggregate value of unvested shares, forfeitures.
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v3.23.2
Equity-Based Compensation (Details Narrative) - $ / shares
|
6 Months Ended |
|
|
Jun. 30, 2023 |
Jan. 31, 2023 |
Oct. 31, 2019 |
Share-Based Payment Arrangement [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Weighted average grant date fair value of options granted |
$ 6.38
|
|
|
Weighted average remaining service period |
1 year
|
|
|
Restricted Stock [Member] | Employees, Directors and Consultants [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Share based compensation vesting period |
1 year
|
|
|
Restricted stock shares, gross |
13,272
|
|
|
2019 Stock Incentive Plan [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Share-based compensation, number of shares authorized |
|
125,000
|
25,000
|
Share-based compensation, description |
A provision in the 2019 Plan provides for an automatic annual increase
equal to 6% of the total number of shares of Common Stock outstanding on December 31 of the preceding calendar year
|
|
|
Share-based compensation number of shares, grant |
|
36,498
|
|
Share based compensation vesting period |
3 years
|
|
|
2019 Stock Incentive Plan [Member] | Minimum [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Options life |
3 years
|
|
|
2019 Stock Incentive Plan [Member] | Maximum [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Options life |
10 years
|
|
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v3.23.2
Schedule of Unit Purchase Stock Options Activity (Details)
|
6 Months Ended |
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of shares, options outstanding, beginning balance | shares |
64,850
|
Weighted average exercise price, outstanding, beginning balance |
$ 68.00
|
Aggregate intrinsic value, outstanding, beginning balance | $ |
|
Number of unit purchase options, granted | shares |
59,048
|
Weighted average exercise price, granted |
$ 7.74
|
Number of unit purchase options, exercised | shares |
297
|
Weighted average exercise price, exercised |
$ 8.00
|
Aggregate intrinsic value, exercised | $ |
|
Number of unit purchase options, canceled | shares |
2,346
|
Weighted average exercise price, canceled |
$ 72.38
|
Aggregate intrinsic value, canceled |
|
Number of shares, options outstanding, ending balance | shares |
121,255
|
Weighted average exercise price, outstanding, ending balance |
$ 2.10
|
Aggregate intrinsic value, outstanding, ending balance | $ |
|
Unit Purchase Options [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of shares, options outstanding, beginning balance | shares |
4,649
|
Weighted average exercise price, outstanding, beginning balance |
$ 64.00
|
Aggregate intrinsic value, outstanding, beginning balance | $ |
|
Number of unit purchase options, granted | shares |
|
Weighted average exercise price, granted |
|
Aggregate intrinsic value, granted |
|
Number of unit purchase options, exercised | shares |
|
Weighted average exercise price, exercised |
|
Aggregate intrinsic value, exercised | $ |
|
Number of unit purchase options, canceled | shares |
|
Weighted average exercise price, canceled |
|
Aggregate intrinsic value, canceled |
|
Number of shares, options outstanding, ending balance | shares |
4,649
|
Weighted average exercise price, outstanding, ending balance |
$ 64.00
|
Aggregate intrinsic value, outstanding, ending balance | $ |
|
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v3.23.2
Schedule of Warrants Activity (Details)
|
6 Months Ended |
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Unit Purchase Options And Warrants |
|
Number of warrants, outstanding, beginning balance | shares |
25,864
|
Weighted average exercise price, outstanding, beginning balance | $ / shares |
$ 30.20
|
Aggregate intrinsic value, outstanding, beginning balance | $ |
|
Number of warrants, granted | shares |
432,618
|
Weighted average exercise price, granted | $ / shares |
$ 12.60
|
Aggregate intrinsic value, granted | $ |
|
Number of warrants, exercised | shares |
(115,000)
|
Weighted average exercise price, exercised | $ / shares |
$ 0.20
|
Aggregate intrinsic value, exercised | $ |
|
Number of warrants, canceled | shares |
|
Weighted average exercise price, canceled | $ / shares |
|
Aggregate intrinsic value, canceled | $ |
|
Number of warrants, outstanding, ending balance | shares |
378,849
|
Weighted average exercise price, outstanding, ending balance | $ / shares |
$ 20.41
|
Aggregate intrinsic value, outstanding, ending balance | $ |
|
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v3.23.2
v3.23.2
Subsequent Events (Details Narrative) - USD ($)
|
|
|
|
|
|
|
|
|
6 Months Ended |
|
|
|
Aug. 10, 2023 |
Aug. 10, 2023 |
Aug. 08, 2023 |
Aug. 04, 2023 |
Jul. 28, 2023 |
Jul. 19, 2023 |
Jul. 11, 2023 |
Jul. 10, 2023 |
Jul. 07, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Feb. 17, 2023 |
Feb. 03, 2023 |
Dec. 29, 2022 |
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of warrant purchase, shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
17,500
|
Share price |
|
|
|
|
|
|
|
|
|
|
|
$ 10.40
|
$ 10.40
|
|
Proceeds from Issuance of Common Stock |
|
|
|
|
|
|
|
|
|
$ 2,728,938
|
$ 315,000
|
|
|
|
Debt Instrument, Interest Rate, Stated Percentage |
|
|
|
|
|
|
|
|
|
10.00%
|
|
|
|
|
Debt Instrument, Maturity Date |
|
|
|
|
|
|
|
|
|
Dec. 31, 2023
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares |
|
|
|
|
|
|
|
|
|
184,000
|
4,731
|
|
|
|
Exercise price |
|
|
|
|
|
|
|
|
|
|
|
$ 15.00
|
$ 15.00
|
|
Share price |
|
|
|
|
|
|
|
|
|
$ 20.00
|
|
|
|
|
Subsequent Event [Member] | Wisconsin Fertility Institute Acquisition [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase price |
|
$ 10,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Paid to acquire amount |
|
2,500,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Net payment to acquire amount |
|
2,150,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment to acquire holdback |
|
350,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Inter-company loan owed |
|
528,756
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Member] | Wisconsin Fertility Institute Acquisition [Member] | Three Installments [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Paid to acquire amount |
|
$ 2,500,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Member] | Wisconsin Fertility Institute Acquisition [Member] | Second Installments [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share price |
$ 125.00
|
$ 125.00
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Member] | Wisconsin Fertility Institute Acquisition [Member] | Third Installments [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share price |
181.80
|
181.80
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Member] | Wisconsin Fertility Institute Acquisition [Member] | Final Installments [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share price |
$ 285.80
|
$ 285.80
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Member] | Peak One Opportunity Fund L P [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Repayments of debt |
$ 100,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument, Interest Rate, Stated Percentage |
8.00%
|
8.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument, Maturity Date |
Feb. 03, 2024
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument, Fee Amount |
$ 7,784
|
$ 7,784
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Member] | First Fire Global Opportunities Fund L L C [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Repayments of debt |
$ 39,849
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument, Interest Rate, Stated Percentage |
8.00%
|
8.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument, Maturity Date |
Feb. 17, 2024
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument, Fee Amount |
$ 3,127
|
$ 3,127
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Member] | JAG Demand Note [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt instrument face amount |
|
|
|
|
|
|
|
$ 100,000
|
|
|
|
|
|
|
Debt instrument payment value |
|
|
|
|
|
|
|
500,000
|
|
|
|
|
|
|
Repayments of debt |
|
|
|
|
|
|
|
$ 500,000
|
|
|
|
|
|
|
Subsequent Event [Member] | Standard Merchant Cash Advance Agreement [Member] | Cedar [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Repayments of debt |
|
|
|
|
|
$ 19,419.64
|
|
|
|
|
|
|
|
|
Receivables purchased value |
|
|
|
|
|
543,750
|
|
|
|
|
|
|
|
|
Gross purchase price |
|
|
|
|
|
375,000
|
|
|
|
|
|
|
|
|
Proceeds from debt |
|
|
|
|
|
356,250
|
|
|
|
|
|
|
|
|
Amount payable related to purchase price |
|
|
|
|
|
$ 465,000
|
|
|
|
|
|
|
|
|
Subsequent Event [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reverse stock split |
|
|
|
|
1-for-20
reverse stock split
|
|
|
|
|
|
|
|
|
|
Number of shares of common stock for fractional shares |
|
|
|
|
135
|
|
|
|
|
|
|
|
|
|
Common Stock Consultants in Consideration [Member] | Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares |
|
|
26,391
|
|
|
|
16,250
|
|
|
|
|
|
|
|
Armistice Amendment [Member] | Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amendment fee |
|
|
|
|
|
|
|
|
$ 1,000,000
|
|
|
|
|
|
Purchase Agreements [Member] | Subsequent Event [Member] | Public Offering [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amendment fee |
$ 1,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued in transaction |
|
|
|
1,580,000
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
|
|
|
$ 2.85
|
|
|
|
|
|
|
|
|
|
|
Number of warrants, shares |
|
|
|
1,580,000
|
|
|
|
|
|
|
|
|
|
|
Number of warrant purchase, shares |
|
|
|
3,160,000
|
|
|
|
|
|
|
|
|
|
|
Share price |
|
|
|
$ 2.85
|
|
|
|
|
|
|
|
|
|
|
Proceeds from Issuance of Common Stock |
|
|
|
$ 4,500,000
|
|
|
|
|
|
|
|
|
|
|
Proceeds from Issuance or Sale of Equity |
|
|
$ 2,150,000
|
|
|
|
|
|
|
|
|
|
|
|
[custom:ProceedsFromIssuancHoldback] |
|
|
$ 350,000
|
|
|
|
|
|
|
|
|
|
|
|
Placement Agency Agreement [Member] | Subsequent Event [Member] | Maxim Group L L C [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
|
|
|
$ 3.14
|
|
|
|
|
|
|
|
|
|
|
Number of warrant purchase, shares |
|
|
|
110,600
|
|
|
|
|
|
|
|
|
|
|
Percentage of pay placement agent aggregate fee |
|
|
|
7.00%
|
|
|
|
|
|
|
|
|
|
|
Percentage of investors |
|
|
|
5.00%
|
|
|
|
|
|
|
|
|
|
|
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