UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-K
For the fiscal year ended December 31, 2023
or
For the transition period from to
INVO
BIOSCIENCE, INC.
(Exact
name of registrant as specified in Charter)
5582
Broadcast CourtSarasota, Florida, 34240
(Address
of Principal Executive Offices)
Registrant’s
telephone number, including area code: (978)878-9505
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 if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES ☐ NO ☒
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. YES ☐ NO ☒
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 has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. ☐
If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). YES ☐ NO ☒
The
aggregate market value of the voting stock and non-voting common equity held by non-affiliates of the registrant as of the last business
day of the registrant’s most recently completed second fiscal quarter ended June 30, 2023 was $3,072,404 based upon the closing
price of the registrant’s common stock of $4.00 on the NASDAQ as of that date.
The
number of shares outstanding of the registrant’s common stock, $0.0001 par value, as of April 16, 2024 was 2,743,031.
DOCUMENTS
INCORPORATED BY REFERENCE
Portions
of the registrant’s Proxy Statement for the 2023 Annual Meeting of Stockholders are incorporated herein by reference in Part III
of this Annual Report on Form 10-K to the extent stated herein. Such proxy statement will be filed with the Securities and Exchange Commission
within 120 days of the registrant’s fiscal year ended December 31, 2023.
FORM
10-K
INVO
BIOSCIENCE, INC.
TABLE
OF CONTENTS
Page
Part I
Item 1. Business 4
Item 1A. Risk Factors 18
Item 1B. Unresolved Staff Comments 34
Item 1C. Cybersecurity 34
Item 2. Properties 34
Item 3. Legal Proceedings 34
Item 4. Mine Safety Disclosures 34
Part II
Item 6. [Reserved] 36
Item 7A. Quantitative and Qualitative Disclosure About Market Risk 54
Item 8. Financial Statements and Supplementary Data 55
Item 9A. Controls and Procedures 56
Item 9B. Other Information 57
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 57
Part III
Item 10. Directors, Executive Officers and Corporate Governance 57
Item 11. Executive and Director Compensation 57
Item 14. Principal Accountant Fees and Services 57
Part IV
Item 15. Exhibits, Financial Statement Schedules 58
SIGNATURES 64
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain
statements, other than purely historical information, including estimates, projections, statements relating to our business plans,
objectives, and expected operating results, and the assumptions upon which those statements are based, are “forward-looking
statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of
1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements generally are identified by the words
“believes,” “project,” “expects,” “anticipates,” “estimates,”
“intends,” “strategy,” “plan,” “may,” “will,” “would,”
“will be,” “will continue,” “will likely result,” and similar expressions. We intend such
forward-looking statements to be covered by the safe-harbor provisions for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995, and are including this statement for purposes of complying with those safe-harbor
provisions. Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties
which may cause actual results to differ materially from the forward-looking statements. Our ability to predict results or the
actual effect of future plans or strategies is inherently uncertain. Factors which could have a material adverse effect on our
operations and future prospects on a consolidated basis include, but are not limited to changes in economic conditions, legislative
or regulatory changes, availability of capital, interest rates, competition, and the impact of the COVID-19 pandemic on our ability
to advance our clinical programs and raise additional financing and generally accepted accounting principles. These risks and
uncertainties should also be considered in evaluating forward-looking statements and undue reliance should not be placed on such
statements. We undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new
information, future events or otherwise. Further information concerning our business, including additional factors that could
materially affect our financial results, is included herein and in our other filings with the Securities and Exchange Commission (“SEC”).
Part
I
Item
1. Business
Introduction
This
Annual Report on Form 10-K should be read together and in connection with the other reports that have been filed by us with the SEC for
a comprehensive description of our financial condition and operating results. In the interest of disclosure, we have included in this
Form 10-K certain material events and developments that have taken place through the date of filing of this Form 10-K with the SEC.
In
this Annual Report on Form 10-K, INVO Bioscience, Inc. (INVO Bioscience, Inc., together with its subsidiaries, is referred to in this
document as “we”, “us”, “INVO Bioscience”, “INVO”, or the “Company”), incorporates
by reference certain information from parts of other documents filed with the SEC.
The SEC allows us to disclose important information by referring to it in that manner. Please refer to all such information when reading
this Annual Report on Form 10-K. All information is as of December 31, 2023, unless otherwise indicated. For a description of the risk
factors affecting or applicable to our business, see “Risk Factors,” below.
The
Company
We are a healthcare services fertility company dedicated
to expanding the assisted reproductive technology (“ART”) marketplace by making fertility care more accessible and inclusive
to people around the world. Our commercial strategy is primarily focused on operating fertility-focused clinics, which includes the opening
of dedicated “INVO Centers” offering the INVOcell® and IVC procedure (with three centers in North America now operational)
and the acquisition of US-based, profitable in vitro fertilization (“IVF”) clinics (with the first acquired in August 2023).
We also continue to engage in the sale and distribution of our INVOcell technology solution into existing independently owned and operated
fertility clinics. While the INVOcell remains important to our efforts, our commercial and corporate development strategy has expanded
to focus more broadly on providing ART services in general through our emphasis on clinic-based operations. We anticipate furthering these
activities with a focus on the acquisition of existing IVF clinics as well as on the opening of dedicated “INVO Centers” offering
the INVOcell and IVC procedure.
Acquisitions:
On
August 10, 2023, we consummated the first acquisition of an existing IVF clinic, the Wisconsin Fertility Institute (“WFI”).
As an established and profitable clinic, the closing of the WFI acquisition more than tripled the Company’s current annual revenues
and became a major part of the Company’s clinic-based operations. The acquisition is accelerating the transformation of INVO to a healthcare
services company and immediately added scale and positive cash flow to the operations. It also complements the Company’s existing
new-build INVO Center efforts. The Company expects to continue to pursue additional acquisitions of established and profitable existing
fertility clinics as part of its ongoing strategy to accelerate overall growth.
INVOcell:
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 lower cost than 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. The IVC procedure can provide benefits, including the following:
● Providing a natural, stable incubation environment;
● Offering a more personal, intimate experience in creating a baby; and
● Reducing 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.
Recent
Developments
NAYA
Biosciences Merger Agreement
On
October 22, 2023, the Company, INVO Merger Sub Inc., a wholly owned subsidiary of the Company and a Delaware corporation (“Merger
Sub”), and NAYA Biosciences, Inc., a Delaware corporation (“NAYA”), entered into an Agreement and Plan of Merger, as
amended on October 25, 2023 (the “Merger Agreement”).
Upon
the terms and subject to the conditions set forth in the Merger Agreement, Merger Sub will merge (the “Merger”) with and
into NAYA, with NAYA continuing as the surviving corporation and a wholly owned subsidiary of the Company.
At
the effective time and as a result of the Merger, each share of Class A common stock, par value $0.000001 per share, of NAYA (the “NAYA
common stock”) outstanding immediately prior to the effective time of the Merger, other than certain excluded shares held by NAYA
as treasury stock or owned by the Company or Merger Sub, will be converted into the right to receive 7.33333 (subject to adjustment as
set forth in the Merger Agreement) shares of a newly designated series of common stock, par value $0.0001 per share, of the Company which
shall be entitled to ten (10) votes per each share (“Company Class B common stock”) for a total of approximately 18,150,000
shares of the Company (together with cash proceeds from the sale of fractional shares, the “Merger Consideration”).
Immediately
following the effective time of the Merger, Dr. Daniel Teper, NAYA’s current chairman and chief executive officer, will be named
chairman and chief executive officer of the Company, and the board of directors will be comprised of at least nine (9) directors, of
which (i) one shall be Steven Shum, INVO’s current chief executive officer, and (ii) eight shall be identified by NAYA, of which
seven (7) shall be independent directors.
The
completion of the Merger is subject to satisfaction or waiver of certain customary mutual closing conditions, including (1) the adoption
of the Merger Agreement by the stockholders of the Company and NAYA, (2) the absence of any injunction or other order issued by a court
of competent jurisdiction or applicable law or legal prohibition prohibiting or making illegal the consummation of the Merger, (3) the
completion of due diligence, (4) the completion of a private sale of the Company’s preferred stock at a price per share of $5.00
per share, in a private offering resulting in an amount equal to at least $2,000,000 of gross proceeds to INVO in the aggregate, plus
an additional amount as may be required prior to closing of the Merger to be determined in good faith by the parties to adequately support
INVO’s fertility business activities per an agreed forecast of INVO, as well as for a period of twelve (12) months post-Closing
including a catch-up on INVO’s past due accrued payables still outstanding (the “Interim PIPE”), (5) the aggregate
of the liabilities of the Company, excluding certain specified liabilities, shall not exceed $5,000,000, (6) the receipt of waivers from
any and all holders of warrants (and any other similar instruments) to securities of the Company, with respect to any fundamental transaction
rights such warrant holders may have under any such warrants, (7) the continued listing of the Company common stock on NASDAQ through
the effective time of the Merger and the approval for listing on NASDAQ of the shares of the Company common stock to be issued in connection
with the Merger, the interim private offering, and a private offering of shares of Company common stock at a target price of $5.00 per
share (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization
with respect to the Company common stock) resulting in sufficient cash available for the Company for one year of operations, as estimated
by NAYA, (8) the effectiveness of a registration statement on Form S-4 to be filed by the Company pursuant to which the shares of Company
common stock to be issued in connection with the Merger will be registered with the SEC, and the absence of any stop order suspending
such effectiveness or proceeding for the purpose of suspending such effectiveness being pending before or threatened by the SEC, and
(9) the Company shall have received customary lock-up Agreement from certain Company stockholders. The obligation of each party to consummate
the Merger is also conditioned upon (1) the other party having performed in all material respects its obligations under the Merger Agreement
and (2) the other party’s representations and warranties in the Merger Agreement being true and correct (subject to certain materiality
qualifiers); provided, however, that these conditions, other than with respects to certain representations and warranties, will be deemed
waived by the Company upon the closing of the interim private offering.
The
Merger Agreement contains termination rights for each of the Company and NAYA, including, among others: (1) if the consummation of
the Merger does not occur on or before December 31, 2023 (the “End Date”) (which has since been extended to April 30, 20204), except that any party whose material breach
of the Merger Agreement caused or was the primary contributing factor that resulted in the failure of the Merger to be consummated
on or before the End Date, (2) if any governmental authority has enacted any law or order making illegal, permanently enjoining, or
otherwise permanently prohibiting the consummation of the Merger, and (3) if the required vote of the stockholders of either the
Company or NAYA has not been obtained. The Merger Agreement contains additional termination rights for NAYA, including, among
others: (1) if the Company materially breaches its non-solicitation obligations or fails to take all action necessary to hold a
stockholder meeting to approve the transactions contemplated by the Merger Agreement, (2) if the aggregate of the liabilities of the
Company, excluding certain specified liabilities, exceed $5,000,000, (3) if NAYA determines that the due diligence contingency will
not be satisfied by October 26, 2023, (4) if NAYA determines that the Company has experienced a material adverse effect, or (5) the
Company material breaches any representation, warranty, covenant, or agreement such that the conditions to closing would not be
satisfied and such breach is incapable of being cured, unless such breach is caused by NAYA’s failure to perform or comply
with any of the covenants, agreements, or conditions hereof to be performed or complied with by it prior to the closing.
If
all of NAYA’s conditions to closing are satisfied or waived and NAYA fails to consummate the Merger, NAYA would be required to
pay the Company a termination fee of $1,000,000. If all of the Company’s conditions to closing conditions are satisfied or waived
and the Company fails to consummate the Merger, the Company would be required to pay NAYA a termination fee of $1,000,000.
On
December 27, 2023, the Company entered into second amendment (“Second Amendment”) to the Merger Agreement. Pursuant to the
Second Amendment, the parties agreed to extend the End Date to April 30, 2024. The parties further agreed to modify the closing condition
for the Interim PIPE from a private offering of shares of Company common stock at a price that is a premium to the market price of the
Company common stock in an estimated amount of $5,000,000 or more of gross proceeds to a private offering of the Company’s preferred
stock at a price per share of $5.00 per share in an amount equal to at least $2,000,000 to the Company, plus an additional amount as
may be required prior to closing of the Merger to be determined in good faith by the parties to adequately support the Company’s
fertility business activities per an agreed forecast, as well as for a period of twelve (12) months post-closing including a catch-up
on the Company’s past due accrued payables still outstanding. The parties further agreed to the following schedule (the “Minimum
Interim Pipe Schedule”) for the initial $2,000,000: (1) $500,000 no later than December 29, 2023, (2) $500,000 no later than January
19, 2024, (3) $500,000 no later than February 2, 2024, and (4) $500,000 no later than February 16, 2024. The parties also further agreed
to modify the covenant of the parties regarding the Interim PIPE to require NAYA to consummate the Interim PIPE before the closing of
the Merger; provided, however, if the Company does not receive the initial gross proceeds pursuant to the Minimum Interim Pipe Schedule,
the Company shall be free to secure funding from third parties to make up for short falls on reasonable terms under SEC and Nasdaq regulations.
NAYA
Securities Purchase Agreement
On
December 29, 2023, the Company entered into a securities
purchase agreement (the “SPA”) with NAYA for NAYA’s purchase of 1,000,000 shares of the Company’s Series A Preferred
Stock at a purchase price of $5.00 per share. The parties agreed that NAYA’s purchases will be made in tranches in accordance with
the Minimum Interim Pipe Schedule. The SPA contains customary representations, warranties
and covenants of the Company and NAYA.
On January 4, 2024, the Company and
NAYA closed on 100,000 shares of Series A Preferred Stock in the first tranche of this private offering for gross proceeds of $500,000.
On Apil 15, 2024, the Company and NAYA closed on additional 61,200 shares of Series A Preferred Stock for additional gross
proceeds of $306,000.
Wisconsin
Fertility Institute Acquisition
On
August 10, 2023, INVO, through Wood Violet Fertility LLC, a Delaware limited liability company (“WVF”) and wholly owned
subsidiary of INVO CTR, consummated its acquisition of WFI for a combined purchase price of $10 million, of which $2.5 million was paid
on the closing date (net cash paid was $2,150,000 after a $350,000 holdback) plus assumption of the inter-company loan owed by WFRSA
(as defined below) in the amount of $528,756. 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.
WFI
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 WFI’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
purchased the non-medical assets of WFRSA and one hundred percent of FLOW’s membership interests. WVF and WFRSA entered into
a management services agreement pursuant to which WFRSA outsourced all its non-medical activities to WVF.
FirstFire
Securities Purchase Agreement
On
April 5, 2024, the Company entered into a purchase agreement (the “FirstFire Purchase Agreement”) with FirstFire Global Opportunities
Fund, LLC (“FirstFire”), pursuant to which FirstFire agreed to purchase, and the Company agreed to issue and sell, (i) a
promissory note with an aggregate principal amount of $275,000.00, which is convertible into shares of the Company’s common stock,
according to the terms, conditions, and limitations outlined in the note (the “FirstFire Note”), (ii) a warrant (the “First
Warrant”) to purchase 229,167 shares (the “First Warrant Shares”) of the Company’s common stock at an exercise
price of $1.20 per share, (iii) a warrant (the “Second Warrant”) to purchase 500,000 shares (the “Second Warrant Shares”)
of common stock at an exercise price of $0.01 issued to FirstFire, and (iv) 50,000 shares of common stock (the “Commitment Shares”),
for a purchase price of $250,000. Carter, Terry, & Company, Inc. acted as placement agent for the transaction, for which it received
a cash fee of $25,000. The proceeds are being used for working capital and general corporate purposes.
Among
other limitations, the total cumulative number of shares of common stock that may be issued to FirstFire under the FirstFire Purchase
Agreement may not exceed the requirements of Nasdaq Listing Rule 5635(d), except that such limitation will not apply in the event the
Company obtains stockholder approval of the shares of common stock to be issued under the Purchase Agreement, if necessary, in accordance
with the requirements of Nasdaq Listing Rule 5635(d). The Company has agreed to hold a meeting for the purpose of obtaining this stockholder
approval within nine (9) months of the date of the FirstFire Purchase Agreement.
The
FirstFire Purchase Agreement contains customary representations, warranties, and covenants by each of the Company and FirstFire. Among
other covenants of the parties, the Company granted FirstFire the right to participate in any subsequent placement of securities until
the earlier of eighteen (18) months after the date of the FirstFire Purchase Agreement or extinguishment of the FirstFire Note. The Company
has also granted customary “piggy-back” registration rights to FirstFire with respect to the shares of common stock underlying
the FirstFire Note (the “Conversion Shares”), the First Warrant Shares, the Second Warrant Shares, and the Commitment Shares.
FirstFirehas covenanted not to cause or engage in any
short selling of shares of common stock until the FirstFire Note is fully repaid.
The
following sets forth the material terms of the FirstFire Note, the First Warrant, and the Second Warrant.
FirstFire
Note
Interest
and Maturity. The FirstFire Note carries an interest rate of twelve percent (12%) per annum, with the first twelve months of interest,
amounting to $33,000.00, guaranteed, and fully earned as of the issue date. The maturity date of the FirstFire Note is twelve (12) months
from the issue date, at which point the Principal Amount, together with any accrued and unpaid interest and other fees, shall be due
and payable to the holder of the FirstFire Note.
Conversion.
The holder of the FirstFire Note is entitled to convert any portion of the outstanding and unpaid principal amount and accrued interest
into Conversion Shares at a conversion price of $1.00 per share, subject to adjustment. The FirstFire Note may not be converted and Conversion
Shares may not be issued under the FirstFire Note if, after giving effect to the conversion or issuance, the holder together with its
affiliates would beneficially own in excess of 4.99% of the outstanding common stock. In addition to the beneficial ownership limitations
in the FirstFire Note, the number of shares of common stock that may be issued under the FirstFire Note, the First Warrant, the Second
Warrant, and under the FirstFire Purchase Agreement (including the Commitment Shares) is limited to 19.99% of the outstanding common
stock as of April 5, 2024 (the “Exchange Cap”, which is equal to 523,344 shares of common stock, subject to adjustment as
described in the FirstFire Purchase Agreement), unless stockholder approval is obtained by the Company to issue more than the Exchange
Cap. The Exchange Cap shall be appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse
stock split or other similar transaction.
Prepayment.
The Company may prepay the FirstFire Note at any time in whole or in part by paying a sum of money equal to 110% of the sum of the principal
amount to be redeemed plus the accrued and unpaid interest.
Future
Proceeds. While any portion of the FirstFire Note is outstanding, if the Company receives cash proceeds of more than $1,500,000 from
any source or series of related or unrelated sources, or more than $1,000,000 from any public offering (the “Minimum Threshold”),
the Company shall, within one (1) business day of Company’s receipt of such proceeds, inform FirstFire of such receipt, following
which FirstFire shall have the right in its sole discretion to require the Company to immediately apply up to 100% of all proceeds received
by the Company above the Minimum Threshold to repay the outstanding amounts owed under the FirstFire Note.
Covenants.
The Company is subject to various covenants that restrict its ability to, among other things, declare dividends, make certain investments,
sell assets outside the ordinary course of business, or enter into transactions with affiliates, thereby ensuring the Company operational
and financial activities are conducted in a manner that prioritizes the repayment of the FirstFire Note.
Events
of Default. The FirstFire Note outlines specific events of default and provides FirstFire certain rights and remedies in such events,
including but not limited to the acceleration of the FirstFire Note’s due date and a requirement for the Company to pay a default
amount. Specific events that constitute a default under the FirstFire Note include, but are not limited to, failure to pay principal
or interest when due, breaches of covenants or agreements, bankruptcy or insolvency events, and a failure to comply with the reporting
requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Upon an event of default, the FirstFire
Note becomes immediately due and payable, and the Borrower is subject to a default sum as stipulated.
The
FirstFire Note is subject to, and governed by, the terms and conditions of the FirstFire Purchase Agreement.
First
Warrant
The
First Warrant grants the holder thereof the right to purchase up to 229,167 shares of common stock at an exercise price of $1.20 per
share.
Exercisability.
The First Warrant is be immediately exercisable and will expire five years from the issuance date. The First Warrant is exercisable,
at the option of the holder, in whole or in part, by delivering to the Company a duly executed exercise notice and, at any time a registration
statement registering the issuance of the First Warrant Shares under the Securities Act of 1933, as amended (the “Securities Act”)
is effective and available for the issuance of such First Warrant Shares, or an exemption from registration under the Securities Act
is available for the issuance of such First Warrant Shares, by payment in full in immediately available funds for the number of First
Warrant Shares purchased upon such exercise. If a registration statement registering the issuance of the First Warrant Shares underlying
the First Warrant under the Securities Act is not effective or available, the holder may, in its sole discretion, elect to exercise the
First Warrant through a cashless exercise, in which case the holder would receive upon such exercise the net number of First Warrant
Shares determined according to the formula set forth in the First Warrant.
Exercise
Limitation. A holder will not have the right to exercise any portion of the First Warrant if the holder (together with its affiliates)
would beneficially own in excess of 4.99% of the number of shares of the common stock outstanding immediately after giving effect to
the exercise, as such percentage ownership is determined in accordance with the terms of the First Warrant.
Trading
Market Regulation. Until the Company has obtained stockholder approval of the FirstFire Purchase Agreement and the issuance of the
securities issued pursuant thereto, the Company may not issue any First Warrant Shares upon the exercise of the First Warrants if the
issuance of such First Warrant Shares, (taken together with the issuance of any shares held by or issuable to the holder under the FirstFire
Purchase Agreement or any other agreement with the Company) would exceed the aggregate number of shares which the Company may issue without
breaching 523,344 shares (19.9% of the Company’s outstanding common stock) or any of the Company’s obligations under the
rules or regulations of Nasdaq.
Exercise
Price Adjustment. Subject to the aforementioned limitations, the exercise price of the First Warrant is subject to appropriate adjustment
in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting
the common stock, upon any distributions of assets, including cash, stock or other property to our stockholders, and if we issue additional
shares of common stock at a price per share that is less than the exercise price then in effect.
Fundamental
Transactions. The Company shall not enter into or be a party to a fundamental transaction unless the successor entity assumes all
obligations of the Company under the First Warrant and other transaction documents. Upon consummation of a fundamental transaction, then
the successor entity will succeed to, and be substituted for the Company, and may exercise every right and power that the Company may
exercise and will assume all of the Company’s obligations under the First Warrant with the same effect as if such successor entity
had been named in the First Warrant itself.
Rights
as a Stockholder. Except as otherwise provided in the First Warrant or by virtue of such holder’s ownership of shares of common
stock, the holder of the First Warrant will not have the rights or privileges of a holder of common stock, including any voting rights,
until the holder exercises the First Warrant.
Second
Warrant
The
Second Warrant grants the holder thereof the right to purchase up to 500,000 shares of common stock at an exercise price of $0.01 per
share.
Exercisability.
The Second Warrant will only become exercisable on the specific Triggering Event Date, which is the date that an Event of Default occurs
under the Note, and will expire five years from such date. The Second Warrant includes a ‘Returnable Warrant’ clause, providing
that the Second Warrant shall be cancelled and returned to the Company if the Note is fully extinguished before any Triggering Event
Date. The Second Warrant will be exercisable, at the option of each holder, in whole or in part by delivering to the Company a duly executed
exercise notice and, at any time a registration statement registering the issuance of the Second Warrant Shares under the Securities
Act is effective and available for the issuance of such Second Warrant Shares, or an exemption from registration under the Securities
Act is available for the issuance of such shares, by payment in full in immediately available funds for the number of Second Warrant
Shares purchased upon such exercise. If a registration statement registering the issuance of Second Warrant Shares under the Securities
Act is not effective or available, the holder may, in its sole discretion, elect to exercise the Second Warrant through a cashless exercise,
in which case the holder would receive upon such exercise the net number of Second Warrant Shares determined according to the formula
set forth in the warrant.
Exercise
Limitation. A holder will not have the right to exercise any portion of the Second Warrant if the holder (together with its affiliates)
would beneficially own in excess of 4.99% of the number of shares of the common stock outstanding immediately after giving effect to
the exercise, as such percentage ownership is determined in accordance with the terms of the Second Warrant.
Trading
Market Regulation. Until the Company has obtained stockholder approval of the FirstFire Purchase Agreement and the issuance of the
securities issued pursuant thereto, the Company may not issue any Second Warrant Shares upon the exercise of the Second Warrants if the
issuance of such Second Warrant Shares, (taken together with the issuance of any shares held by or issuable to the holder under the FirstFire
Purchase Agreement or any other agreement with the Company) would exceed the aggregate number of shares which the Company may issue without
breaching 523,344 shares (19.9% of the Company’s outstanding common stock) or any of the Company’s obligations under the
rules or regulations of Nasdaq.
Exercise
Price Adjustment. Subject to the aforementioned limitations, the exercise price of the Second Warrant is subject to appropriate adjustment
in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting
the common stock, upon any distributions of assets, including cash, stock or other property to our stockholders, and if we issue additional
shares of common stock at a price per share that is less than the exercise price then in effect.
Fundamental
Transactions. The Company shall not enter into or be a party to a fundamental transaction unless the successor entity assumes all
obligations of the Company under the Second Warrant and other transaction documents. Upon consummation of a fundamental transaction,
then the successor entity will succeed to, and be substituted for the Company, and may exercise every right and power that the Company
may exercise and will assume all of the Company’s obligations under the Second Warrant with the same effect as if such successor
entity had been named in the Second Warrant itself.
Rights
as a Stockholder. Except as otherwise provided in the Second Warrant or by virtue of such holder’s ownership of shares of common
stock, the holder of the Second Warrant will not have the rights or privileges of a holder of common stock, including any voting rights,
until the holder exercises the Second Warrant.
Triton
Purchase Agreement
On
March 27, 2024, the Company entered into a purchase agreement (the “Triton
Purchase Agreement”) with Triton Funds LP (“Triton”), pursuant to which the Company agreed to sell, and Triton agreed
to purchase, upon the Company’s request in one or more transactions, up to 1,000,000 shares of the Company’s common stock,
par value $0.0001 per share, providing aggregate gross proceeds to the Company of up to $850,000. Triton will purchase the shares of common
stock under the Triton Purchase Agreement at the price of $0.85 per share. The purchase agreement expires upon the earlier of the sale
of all 1,000,000 shares of the Company’s common stock or December 31, 2024.
Among
other limitations, unless otherwise agreed upon by Triton, each individual sale of shares of common stock will be limited to no more
than the number of shares of common stock that would result in the direct or indirect beneficial ownership by Triton of more than
9.99% of the then-outstanding shares of common stock. In addition, the total cumulative number of shares of common stock that may be
issued to Triton under the Triton Purchase Agreement may not exceed the requirements of Nasdaq Listing Rule 5635(d), except that
such limitation will not apply in the event the Company obtains stockholder approval of the shares of common stock to be issued
under the Triton Purchase Agreement, if necessary, in accordance with the requirements of Nasdaq Listing Rule 5635(d).
The
Triton Purchase Agreement provides that the Company will file a prospectus supplement (the “Prospectus Supplement”) to
its Registration Statement on Form S-3, which was declared effective on April 16, 2021 (File No. 333-255096) (the “Base
Registration Statement”), covering the offering and sale of the shares of common stock to Triton pursuant to the Triton
Purchase Agreement. Triton’s obligation to purchase shares of common stock under the Triton Purchase Agreement is conditioned
upon, among other things, the filing of the Prospectus Supplement and the Base Registration Statement remaining
effective.
The
Triton Purchase Agreement contains customary representations, warranties, and covenants by each of the Company and Triton. Actual
sales of shares of common stock to Triton will depend on a variety of factors to be determined by the Company from time to time,
including, among others, market conditions, the trading price of the common stock and determinations by the Company as to the
appropriate sources of funding for the Company and its operations. Triton has no right to require any sales of shares of common
stock by the Company but is obligated to make purchases of shares of common stock from the Company from time to time, pursuant to
directions from the Company, in accordance with the Triton Purchase Agreement. During the term of the Triton Purchase Agreement,
Triton has covenanted not to cause or engage in any short selling of shares of common stock.
On
March 27, 2024, the Company sold to Triton private placement warrants to purchase up to 1,000,000 shares of our common stock at an exercise
price of $2.00 per share.
On
March 27, 2024, the Company delivered a purchase notice for 260,000 shares of common stock. The Company’s common stock traded below
the purchase price following the date of the purchase notice, giving Triton the right to return to the Company any of the 260,000 shares.
Triton notified the Company that it will return 185,000 shares to the Company and closed the purchase of 75,000 shares pursuant to the
Triton Purchase Agreement.
Future
Receipts Agreement
On
February 26, 2024, the Company finalized an Agreement for the Purchase and Sale of Future Receipts (the “Future Receipts Agreement”)
with a buyer (the “Buyer”) under which the Buyer purchased $344,925 of our future sales for a gross purchase price of $236,250.
The Company received net proceeds of $225,000. Until the purchase price has been repaid, the Company agreed to pay the Buyer $13,797
per week.
Convertible
Note Extension
In
January and March 2023, the Company issued $410,000 of convertible notes (the “Convertible Notes”) with a maturity date of
December 31, 2023. The 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 (the “Q1 2023 Warrants”) to purchase 19,375 shares
of common stock at an exercise price of $20.00.
The
Convertible Notes may be amended with the written consent of the Company and the holders of a majority of the outstanding principal of
the Convertible Notes (the “Required Holders”); provided that, no such amendment, without the written consent of each Convertible
Note holder, may (i) reduce the principal amount or interest rate or change the method of computation of interest (including with respect
to the amount of cash) in the Convertible Notes, (ii) change the percentage of the outstanding principal amount of the Convertible Notes
required to consent to any such amendment or (iii) amend Section 9 (Modifications) of the Convertible Note.
As
of December 27, 2023, the Company secured written consent by the Required Holders for the Convertible Note maturity date to be extended
to June 30, 2024. As an incentive for the Required Holders to approve the extension, the Company agreed to lower both the Convertible
Note fixed conversion price and the Q1 2023 Warrant exercise price to $2.25. The maturity date extension and the conversion and exercise
price reduction applies to all Convertible Notes.
Share
Exchange
On
November 28, 2023, INVO announced that it had received a notice from The Nasdaq Stock Market, LLC (“Nasdaq”), dated November
22, 2023, informing INVO that it has regained compliance with Nasdaq’s Listing Rule 5550(b)(1) (the “Equity Rule”)
for continued listing on The Nasdaq Capital Market, as INVOs stockholders’ equity met or exceeded $2,500,000. INVO will be subject
to a mandatory panel monitor for a period of one year from the date of the notification.
On November 19, 2023, the Company entered into a share exchange agreement (the “Share Exchange Agreement”)
with Cytovia Therapeutics Holdings, Inc., a Delaware corporation (“Cytovia”) for Cytovia’s acquisition of 1,200,000
shares of the Company’s newly designated Series B Preferred Stock in exchange for 163,637 shares of common stock of NAYA held by
Cytovia valued at $6,000,000 (the “Share Exchange”). On November 20, 2023, the Company and Cytovia closed on the exchange
of shares.
As
a result of the exchange and based on the reduction in net loss demonstrated in the Company’s Form 10-Q for the quarter ended September
30, 2023, the ongoing and further expected reduction in certain operating costs, including the end of research and development expenses
related to securing FDA clearance for the INVOcell label update, and profits from the operations of our previously-acquired clinic, Wisconsin
Fertility Institute, the Company’s stockholders’ equity was sufficient to maintain its Nasdaq listing.
As part of the year end of fiscal 2023 audit process, and after considering
all available evidence to evaluate the realizable value of its investment in the NAYA shares, including the financial condition and near-term
prospects of NAYA, the lack of marketability of the shares, and delays experienced with the interim funding commitments by NAYA, the Company
determined that it could not provide sufficient support to value the NAYA shares at $6 million and instead valued the shares at $2,172,000,
the quoted market value of INVO’s common shares underlying the convertible preferred.
Waiver
Solicitation
On
November 9, 2023, the Company announced that we had commenced a solicitation of waivers (the “Waiver Solicitation”) from
holders of our common stock purchase warrants dated August 8, 2023 (the “August Warrants”) of the holder’s right
to exercise a payment option upon consummation of the Merger. Receipt of the waivers is a condition to the consummation of the
Merger. The Waiver Solicitation was being made pursuant to a notice of waiver solicitation (the “Notice of Waiver
Solicitation”) and accompanying form of waiver, which the Company sent to the holders of the August Warrants. The Notice of
Waiver solicitation sets forth the terms of the Warrant Solicitation. As of today, the Company has secured signed waivers from
approximately 87.5% of the August Warrant holders.
On
November 13, 2023, the Company announced our intention to commence an exchange
offer to all holders of the August Warrants to exchange shares of INVO’s common stock for each warrant tendered. The Company expects
to file a Schedule TO in advance of the Merger, at which time it will commence an exchange offer for the August Warrants that will be
open for no less than 20 business days and will expire two trading days after the closing of the Merger.
Under
the terms of the proposed exchange offer, warrant holders will have the opportunity to exchange each warrant held for a number of shares
of common stock equal to the quotient of $2.25 per warrant divided by the closing price of INVO’s common stock on the date of closing
of the Merger.
These
terms and conditions of the exchange offer will be described in an offer to exchange and related letter of transmittal that will be sent
to August Warrant holders shortly after commencement of the exchange offer. The exchange offer will be subject to the closing of the
Merger agreement with NAYA. Tenders of warrants must be made prior to the expiration of the exchange offer period.
Increase
in Authorized Shares
On
October 13, 2023, our stockholders approved an increase to the number of our authorized shares of common stock from 6,250,000 shares
to 50,000,000 shares and we filed a Certificate of Amendment to our Articles of Incorporation with the Nevada Secretary of State on such
date to increase our authorized shares of common stock from 6,250,000 shares to 50,000,000 shares.
Revenue
Loan and Security Agreement
On
September 29, 2023, INVO, Steven Shum, as a Key Person, and our wholly-owned subsidiaries Bio X Cell, Inc, INVO CTR, Wood Violet Fertility
LLC, FLOW and Orange Blossom Fertility LLC as guarantors (the “Guarantors”), entered into a Revenue Loan and Security Agreement
(the “Loan Agreement”) with Decathlon Alpha V LP (the “Lender”) under which the Lender advanced a gross amount
of $1,500,000 to the Company (the “RSLA Loan”). The RSLA Loan has a maturity date of June 29, 2028, is payable in fixed monthly
installments, as set forth in the Loan Agreement, and may be prepaid without penalty at any time. The installments include an interest
factor that varies based on when the RSLA Loan is fully repaid and is based on a minimum amount that increases from thirty five percent
(35%) of the RSLA Loan principal if fully repaid in the first six months to 100% of the RSLA Loan principal if fully repaid after 30
months from the RSLA Loan’s effective date.
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 “August 2023 Offering”), 1,580,000 units (the “Units”) at a price of $2.85 per Unit, with
each Unit consisting of (i) one share of our common stock (the “Shares”), 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. In the aggregate, in
the August 2023 Offering the Company issued 1,580,000 Shares and 3,160,000 Warrants. The securities issued in the August 2023 Offering
were offered pursuant to our registration statement on Form S-1 (File 333-273174) (the “Registration Statement”), initially
filed by us with the SEC under 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 to fund the initial installment of the WFI purchase price (net of a $350,000 holdback) on August 10, 2023; (ii) $1,000,000 to pay Armistice the Armistice Amendment Fee(as defined below); and (iii) $139,849 to repay those certain 8% debentures issued in February 2023, plus accrued interest and fees of approximately $10,911. We are using the remaining proceeds from the August 2023 Offering for working capital and general corporate purposes.
In
connection with the August 2023 Offering, on August 4, 2023, we entered
into a placement agency agreement (the “Placement Agency Agreement”) with Maxim Group LLC (“Maxim”), pursuant
to which (i) Maxim agreed to act as placement agent on a “best efforts” basis in connection with the August 2023 Offering
and (ii) we agreed to pay Maxim an aggregate fee equal to 7.0% of the gross proceeds raised in the August 2023 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 20, 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 (the “Initial Advance”). We received net proceeds
of $356,250. Until the purchase price is repaid, we agreed to pay Cedar $19,419.64 per week. If the Initial Advance is repaid within
30 days, then the amount payable to Cedar shall be reduced to $465,000. In addition, we granted Cedar a security interest in our accounts,
including deposit accounts and accounts receivable. We used the proceeds for working capital and general corporate purposes.
On
August 31, 2023, we refinanced the Initial Advance through the purchase by Cedar of $746,750 of the Company’s receivables for a
gross purchase price of $515,000 (the “Refinanced Advance”). We received net cash proceeds of $134,018 after applying $390,892
towards the repayment of the Initial Advance. The new Cash Advance Agreement provides that if we repay the Refinanced Advance within
30 days then the amount payable to Cedar shall be reduced to $643,750, and if the Refinanced Amount is repaid on days 31 to 60 then the
amount payable to Cedar shall be reduced to $674,650. Until the purchase price is repaid, we agreed to pay Cedar $16,594 per week. On
September 29, 2023, we repaid $0.3 million of the Refinanced Advance with proceeds from the RLSA Loan (as defined below). As a result
of such payment, the weekly payment was reduced to $9277.