ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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(State or Other Jurisdiction of Incorporation)
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(I.R.S. Employer Identification No.)
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(Address of Principal Executive Offices)
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(Zip Code)
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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None |
N/A |
N/A |
Large accelerated filer ☐
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Accelerated filer ☐
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Smaller reporting company
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Emerging growth company
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PART I
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Page
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Item 1.
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4 |
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Item 1A.
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15 |
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Item 1B.
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31 |
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Item 1C.
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31 |
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Item 2.
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32 |
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Item 3.
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32 |
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Item 4.
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32 |
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PART II
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Item 5.
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32 |
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Item 6.
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32 |
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Item 7.
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32 |
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Item 7A.
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37 |
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Item 8.
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38 | |||
Item 9.
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39 |
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Item 9A.
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39 | |||
Item 9B.
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40 | |||
Item 9C.
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40 | |||
PART III
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Item 10.
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40 | |||
Item 11.
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44 |
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Item 12.
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47 |
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Item 13.
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49 |
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Item 14.
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50 |
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PART IV
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Item 15.
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51 |
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Item 16.
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56 |
• |
The dermaPACE® System was determined to be a Class II device by the FDA under the generic name extracorporeal shock wave device for treatment of chronic wounds per De Novo filing/order DEN160037. As a result of this order, we were
immediately able to market dermaPACE as described in the De Novo request subject to the general control provisions of the Federal Food, Drug, and Cosmetic Act and the special controls identified in the order. Besides having permission to
market in the U.S., dermaPACE is licensed for distribution and sale in the following jurisdictions: the European Union (CE Mark), Canada, Brazil, Egypt, Singapore and the United Arab Emirates.
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Profile by SANUWAVE System is marketed only within the U.S. and is listed as a Class I device with the FDA (listing number D065463). Profile by SANUWAVE System is not approved/cleared/licensed in any other jurisdiction.
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The orthoPACE® System is not marketed in the U.S. It is marketed in the European Union (CE Mark) and licensed for sale/distribution in South Korea and Taiwan.
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Growth and expansion of sales across the United States
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Improvement of the functionality and ease-of-use for both medical personnel and patients
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Identifying and qualifying antibacterial and anti-biofilm solutions to replace the saline solution used to produce the mist used by this system to conduct the ultrasound toward its target, which, the Company
believes would make the system more effective in treating bacterial infections associated with skin conditions
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The design of new applicators capable of treating large skin conditions, for improved efficiency in such cases.
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Acute and chronic wound conditions, including diabetic foot ulcers, venous and arterial ulcers, pressure sores, burns and other skin eruption conditions;
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Orthopedic applications, such as eliminating chronic pain in joints from trauma, arthritis or tendons/ligaments inflammation or tendinopathies, speeding the healing of fractures (including nonunion or delayed-union conditions), improving
bone density in osteoporosis, fusing bones in the extremities and spine, and other potential sports injury applications;
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Plastic/cosmetic applications such as cellulite smoothing, graft and transplant acceptance, skin tightening, scarring and other potential aesthetic uses; and
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Cardiovascular applications for removing plaque due to atherosclerosis, eliminating occlusions and blood clots, and improving heart muscle and cardiac valves performance.
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Merger Sub will merge with and into the Company, with the Company being the surviving company following the merger.
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Each issued and outstanding share of the Company common stock will automatically be converted into Class A common stock of SEPA, par value $0.0001 per share, at the Conversion Ratio (as defined in the Merger
Agreement); and
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Outstanding Company convertible securities of the Company will be assumed by SEPA and will be converted into the right to receive Class A Common Stock of SEPA.
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holders of 80% or more of the Company’s convertible notes with a maturity date occurring after the date of the Closing (the “Closing Date”), measured by number of shares of our common stock into which
such convertible notes may be converted, agreeing to convert their convertible notes into shares of common stock immediately prior to the Effective Time.
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holders of 80% or more of the Company’s warrants that would be outstanding on the Closing Date, measured by number of shares of our common stock subject to all such warrants in the aggregate, agreeing to
convert their warrants into shares of common stock immediately prior to the Effective Time.
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SEPA having at the Closing, at least $12,000,000 in cash and cash equivalents, including funds remaining in the trust account (after giving effect to the completion and payment of any redemptions) and the
proceeds of any private placement in SEPA.
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Commercialize and support the domestic distribution of our UltraMIST and PACE systems to treat wounds;
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Reduce and normalize operating costs to support growth;
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Develop and commercialize our noninvasive biological response activating devices in the regenerative medicine area for the treatment of skin, musculoskeletal tissue, and vascular structures.
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Patent #/
Application #
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Title
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Expiration Date
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Jurisdiction
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US 7,867,178
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Apparatus for generating shock waves with piezoelectric fibers integrated in a composite
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Sep 29, 2027
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USA
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US 8,088,073
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Device for the application of acoustic shock waves
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Jun 23, 2025
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USA
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US 8,092,401
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Method and apparatus for producing shock waves for medical applications
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Feb 21, 2027
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USA
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US 8,556,813
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Extracorporeal pressure shock wave device
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Sept 12, 2031
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|
USA
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US 8,961,441
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Medical treatment system including an ancillary
medical treatment apparatus with an associated
data storage medium
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March 13, 2032
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|
USA
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US 9,161,768
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Extracorporeal pressure shock wave devices with reversed applicators and methods for using these devices
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Aug 16, 2030
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USA
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Patent #/
Application #
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|
Title
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Expiration Date
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Jurisdiction
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US 9,198,825
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|
Increase electrode life in devices used for extracorporeal shockwave therapy (ESWT)
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Aug 24, 2033
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USA
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US 9,522,011
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Shock wave applicator with movable electrode
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July 8, 2030
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USA
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US 9,566,209
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|
Shock wave electrodes with fluid holes
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June 21, 2033
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USA
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US 10,058,340
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|
Extracorporeal pressure shock wave devices with multiple reflectors and methods for using these devices
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Nov 9, 2033
|
|
USA
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US 10,769,249
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|
Distributor product programming system
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Feb 24, 2038
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|
USA
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US 11,666,348
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|
Intracorporeal expandable shock wave reflector
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July 8, 2030
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USA
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US 11,925,366
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Catheter with multiple shock wave generators
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July 8, 2030
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USA
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|||
EP 2451422
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Usage of extracorporeal and intracorporeal
pressure shock waves in medicine
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July 8, 2030
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Great Britain, France, Germany, Italy and Spain
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KR 10-2255975
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Distributor product programming system
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May 25, 2038 (app.)
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South Korea
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Patent #/
Application #
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|
Title
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Expiration Date
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Jurisdiction
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US 8,343,420
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Methods and devices for cleaning and sterilization
with shock waves
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July 2, 2031
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USA
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US 8,728,809
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Use of pressure waves for stimulation, proliferation, differentiation and post-implantation viability
of stem cells
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August 25, 2031
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USA
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US 9,119,888
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Methods for cleaning and sterilization of implant tissue ex vivo with shock waves
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Sept 17, 2030
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USA
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US 10,238,405
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Blood vessel treatment with intracorporeal
pressure shock waves
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Jan 19, 2032
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USA
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US 10,569,106
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|
Tissue disinfection with acoustic pressure shock waves
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Sep 28, 2038
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USA
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US 10,639,051
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Occlusion and clot treatment with intracorporeal pressure shock waves
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Sep 29, 2031
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USA
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US 10,888,715
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Acoustic pressure shock waves used for personalized medical treatment of tissue conditions
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May 12, 2039
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USA
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US 11,684,806
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Infected Prosthesis and Implant Treatment with Acoustic Pressure Shock Waves
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July 22, 2037
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USA
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US 11,771,781
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Reprocessing of contaminated reusable devices with direct contact of pressure waves
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May 6, 2041
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USA
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EP 3117784
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Usage of intracorporeal pressure shock waves in medicine
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July 8, 2030
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Great Britain, France, Germany, Italy, Spain, Finland, Belgium, Denmark, Ireland, the Netherlands, Norway, and Sweden
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AU 2016250668
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Tissue disinfection with acoustic pressure shock waves
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March 22, 2036
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Australia
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EP 3461438
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|
Combined intracorporeal and extracorporeal shock wave treatment system
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July 8, 2030
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Great Britain, France, Germany, and the Netherlands
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Patent #/
Application #
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|
Title
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|
Expiration Date
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|
Jurisdiction
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EP 3285661
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|
Tissue disinfection with acoustic
pressure shock waves
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April 22, 2036
|
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Great Britain, France, Germany, Ireland, and the Netherlands
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AU 2017387130
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Acoustic pressure shock waves used for personalized medical treatment of tissue conditions
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Dec 29, 2037
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Australia
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IL 267661
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Acoustic pressure shock waves used for personalized medical treatment of tissue conditions
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Dec 29, 2037 (app.)
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Israel
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BR 112017022768
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Tissue disinfection with acoustic
pressure shock waves
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April 22, 2036
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Brazil
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Patent #/
Application #
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|
Title
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|
Expiration Date
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|
Jurisdiction
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US 7,713,218
|
|
Removable applicator nozzle for ultrasound wound therapy device
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|
May 6, 2028
|
|
USA
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US 7,785,277
|
|
Removable applicator nozzle for ultrasound wound therapy device
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|
Jun 27, 2025
|
|
USA
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US 7,914,470
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|
Ultrasonic method and device for wound treatment
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|
June 27, 2023
|
|
USA
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US 8,491,521
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|
Removable multi-channel applicator nozzle
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|
May 3, 2028
|
|
USA
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US 11,224,767
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|
Systems and methods for producing and delivering ultrasonic therapies for wound treatment and healing
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|
Nov 18, 2034
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|
USA
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US 11,331,520
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|
Systems and methods for producing and delivering ultrasonic therapies for wound treatment and healing
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|
Sept 7, 2035
|
|
USA
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US D733,319
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|
Ultrasonic treatment wand (Design patent)
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|
June 30, 2029
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|
USA
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US D733,321
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|
Ultrasonic treatment device (Design patent)
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|
June 30, 2029
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|
USA
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IN 228689
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Ultrasonic method and device for wound treatment
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April 5, 2024
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India
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HK 1119926
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Removable applicator nozzle for ultrasound wound therapy device
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June 23, 2026
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Hong Kong
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CA 2,463,600
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|
Device and method for ultrasound wound debridement
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|
Aug 4, 2023
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|
Canada
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CA 2,521,117
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|
Ultrasonic method and device for wound treatment
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|
April 5, 2024
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|
Canada
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CA 2,931,612
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|
Systems and methods for producing and delivering ultrasonic therapies for wound treatment and healing
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|
Nov 18, 2034
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|
Canada
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EP 1893104
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Removable applicator nozzle for ultrasound wound therapy device
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July 8, 2026
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Belgium, France, Germany, Ireland, and Great Britain
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AU 2021201720
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|
Systems and methods for producing and delivering ultrasonic therapies for wound treatment and healing
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Nov 18, 2034
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Australia
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• |
Class I: general controls, such as labeling and adherence to quality system regulations;
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Class II: special controls, pre-market notification (510(k)), specific controls such as performance standards, patient registries, and post market surveillance, and additional controls such as labeling and adherence to quality system
regulations; and
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Class III: special controls and approval of a pre-market approval (PMA) application.
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the FDA quality systems regulation, which governs, among other things, how manufacturers design, test, manufacture, exercise quality control over, and document manufacturing of their products;
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labeling and claims regulations, which prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling;
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the Medical Device Reporting regulation, which requires reporting to the FDA of certain adverse experiences associated with use of the product; and
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post market surveillance, including documentation of clinical experience and follow-on, confirmatory studies.
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•
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its employees may experience uncertainty about their future roles, which might adversely affect the Combined Company’s ability to retain and hire key personnel and other employees;
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•
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customers, suppliers, business partners and other parties with which we maintain business relationships may experience uncertainty about its future and seek alternative relationships with third parties, seek
to alter their business relationships with us or fail to extend an existing relationship with the Company; and
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The Company has expended and will continue to expend significant costs, fees and expenses for professional services and transaction costs in connection with the proposed Business Combination.
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the Combined Company may be required to raise additional funds to finance operations and the Combined Company may not be able to do so, and/or the terms of any financings may not be advantageous to the Combined
Company;
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The Company has a history of losses, and the Combined Company may continue to incur losses and may not achieve or maintain profitability;
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the medical device/therapeutic product industries are highly competitive and subject to rapid technological change, so if the Combined Company’s competitors are better able to develop and market products that
are safer and more effective than any products the Combined Company may develop, the Combined Company’s commercial opportunities will be reduced or eliminated;
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if the Combined Company’s products and product candidates do not gain market acceptance among physicians, patients and the medical community, the Combined Company may be unable to generate significant revenues,
if any;
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any product candidates of the Combined Company may not be developed or commercialized successfully;
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the Combined Company may not successfully establish and maintain licensing and/or partnership arrangements for technology for non-medical uses, which could adversely affect the Combined Company’s ability to
develop and commercialize non-medical technology;
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The Company’s product component materials are only produced by a single supplier for such product component. If the Combined Company is unable to obtain product component materials and other products from our
suppliers that the Combined Company will depend on for operations, or find suitable replacement suppliers, the Combined Company’s ability to deliver products to market will likely be impeded, which could have a material adverse effect on the
Combined Company;
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we currently sell products through distributors and partners whose sales account for the majority of revenues and accounts receivable. The Combined Company’s business and results of operations could be
adversely affected by any business disruptions or credit, or other financial difficulties experienced by such distributors or partners;
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the Combined Company faces an inherent risk of liability if the use or misuse of product candidates results in personal injury or death;
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actual or anticipated fluctuations in the Combined Company’s quarterly financial results or the quarterly financial results of companies perceived to be similar to the Combined Company may negatively impact the
trading price of the Combined Company’s securities;
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the Combined Company will be dependent on information technology and the Combined Company’s systems and infrastructure face certain risks, including from cybersecurity breaches and data leakage;
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the Combined Company will generate a portion of revenue internationally and the Combined Company will be subject to various risks relating to international activities which could adversely affect operating
results;
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results of Combined Company clinical trials may be insufficient to obtain regulatory approval for any new product candidates;
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the Combined Company will be subject to extensive governmental regulation, including the requirement of FDA approval or clearance, before any new product candidates may be marketed;
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regulatory approval of the Combined Company’s product candidates may be withdrawn at any time;
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federal regulatory reforms may adversely affect the Combined Company’s ability to sell products profitably;
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failure to obtain regulatory approval in foreign jurisdictions may prevent the Combined Company from marketing products abroad;
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if the Combined Company fails to obtain an adequate level of reimbursement for approved products by third party payers, there may be no commercially viable markets for approved products, or the markets may be
much smaller than expected;
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uncertainty surrounding and future changes to healthcare law in the United States may have a material adverse effect on the Combined Company;
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if the Combined Company fails to comply with the United States Federal Anti-Kickback Statute, False Claims Act and similar state laws, the Combined Company could be subject to criminal and civil penalties and
exclusion from the Medicare and Medicaid programs, which would have a material adverse effect on the business and results of operations;
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if the Combined Company fails to comply with the HIPAA Privacy, Security and Breach Notification Regulations, as such rules become applicable to the Combined Company’s business, it may increase operational
costs;
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the Combined Company will face periodic reviews and billing audits from governmental and private payors and these audits could have adverse results that may negatively impact the business;
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product quality or performance issues may be discovered through ongoing regulation by the FDA and by comparable international agencies, as well as through the Combined Company’s internal standard quality
process;
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the use of hazardous materials in Combined Company operation may subject the Combined Company to environmental claims or liability;
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the protection of the Combined Company’s intellectual property will be critical to the Combined Company’s success and any failure on the Combined Company’s part to adequately protect those rights could
materially adversely affect the business;
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patent applications owned by or licensed to the Combined Company may not result in issued patents, and competitors may commercialize discoveries the Combined Company attempts to patent;
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the Combined Company’s patents may not be valid or enforceable and may be challenged by third parties;
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issued patents and patent licenses may not provide the Combined Company with any competitive advantage or provide meaningful protection against competitors;
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the ability to market the products the Combined Company develops is subject to the intellectual property rights of third parties;
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changes in the market’s expectations about the Combined Company’s operating results;
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success of competitors of the Combined Company;
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the Combined Company’s operating results failing to meet the expectation of securities analysts or investors in a particular period;
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changes in financial estimates and recommendations by any securities analysts that may cover the Combined Company or the industries in which the Combined Company operates in general;
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•
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operating and stock price performance of other companies that investors deem comparable to the Combined Company;
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changes in laws and regulations affecting the Combined Company’s business;
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commencement of, or involvement in, litigation involving the Combined Company;
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changes in the Combined Company’s capital structure, such as future issuances of securities or the incurrence of additional debt;
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the volume of shares of Class A Common Stock available for public sale by the Combined Company;
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any major change in the post-Closing board of directors or management of the Combined Company;
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sales of substantial amounts of Common Stock by directors, executive officers or significant stockholders of the Combined Company, or the perception that such sales could occur; and
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general economic and political conditions such as recessions, pandemics, interest rates, fuel prices, international currency fluctuations and acts of war or terrorism.
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Expertise and resources to analyze and properly apply U.S. GAAP to complex and non-routine transactions such as complex financial instruments and derivatives and complex sales distributing agreements with select vendors.
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A lack of internal resources to analyze and properly apply U.S. GAAP to accounting for financial instruments included in service agreements with select vendors.
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The Company has failed to design and implement controls around all accounting and IT processes and procedures and, as such, we believe that all its accounting and IT processes need to be re-designed and tested for operating effectiveness.
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unanticipated expenditures in research and development or manufacturing activities;
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unanticipated expenditures in the acquisition and defense of intellectual property rights;
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the failure to develop strategic alliances for the marketing of some of our products;
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unforeseen changes in healthcare reimbursement for procedures using any of our approved products;
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inability to train a sufficient number of physicians to create a demand for any of our approved products;
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lack of financial resources to adequately support our operations;
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difficulties in maintaining commercial scale manufacturing capacity and capability;
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unforeseen problems with our third-party manufacturers, service providers or specialty suppliers of certain raw materials;
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unanticipated difficulties in operating in international markets;
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unanticipated financial resources needed to respond to technological changes and increased competition;
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unforeseen problems in attracting and retaining qualified personnel;
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the impact of changes in U.S. health care law and policy on our operations;
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enactment of new legislation or administrative regulations;
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the application to our business of new court decisions and regulatory interpretations;
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claims that might be brought in excess of our insurance coverage;
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delays in timing of receipt of required regulatory approvals;
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the failure to comply with regulatory guidelines; and
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the uncertainty in industry demand and patient wellness behavior.
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required compliance with existing and changing foreign healthcare and other regulatory requirements and laws, such as those relating to patient privacy or handling of bio-hazardous waste;
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required compliance with anti-bribery laws, data privacy requirements, labor laws and anti-competition regulations;
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• |
export or import restrictions;
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political and economic instability,
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• |
foreign exchange controls; and
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difficulties protecting or procuring intellectual property rights.
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advance notice of business to be brought is required for a meeting of our stockholders;
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• |
no cumulative voting rights for the holders of common stock in the election of directors; and
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• |
vacancies in the board of directors may be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum.
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• |
warning letters
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• |
fines and other monetary penalties
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• |
unanticipated expenditures
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• |
product recall or seizure
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• |
interruption of manufacturing
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• |
operating restrictions
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• |
injunctions, and
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• |
criminal prosecutions.
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• |
testing
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• |
manufacturing
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• |
quality control
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• |
labeling
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• |
advertising
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• |
promotion
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• |
distribution
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• |
export
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• |
reporting to the FDA certain adverse experiences associated with the use of the products; and
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• |
obtaining additional approvals or clearances for certain modifications to the products or their labeling or claims.
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• |
required refunding or retroactive adjustment of amounts we have been paid by governmental or private payors;
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• |
state or Federal agencies imposing fines, penalties and other sanctions on us;
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• |
loss of our right to participate in the Medicare program, state programs, or one or more private payor networks; or
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• |
damage to our business and reputation in various markets.
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• |
obtain and/or maintain protection for our products under the patent laws of the United States and other countries;
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• |
defend and enforce our patents once obtained;
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• |
obtain and/or maintain appropriate licenses to patents, patent applications or other proprietary rights held by others with respect to our technology, both in the United States and other countries;
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• |
maintain trade secrets and other intellectual property rights relating to our products; and
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• |
operate without infringing upon the patents, trademarks, copyrights, and proprietary rights of third parties.
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• |
our ability to obtain additional financing and, if available, the terms and conditions of the financing;
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• |
changes in our industry;
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• |
additions or departures of key personnel;
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• |
sales of our common stock;
|
• |
our ability to execute our business plan;
|
• |
operating results that fall below expectations;
|
• |
period-to-period fluctuations in our operating results;
|
• |
new regulatory requirements and changes in the existing regulatory environment; and
|
• |
general economic conditions and other external factors.
|
• |
investors may have difficulty buying and selling, or obtaining market quotations for our common stock;
|
• |
market visibility for our common stock may be limited; and
|
• |
a lack of visibility for our common stock may have a depressive effect on the market for our common stock.
|
Item 1B. |
UNRESOLVED STAFF COMMENTS
|
Item 1C. |
CYBERSECURITY
|
Item 2. |
PROPERTIES
|
Item 3. |
LEGAL PROCEEDINGS
|
Item 4. |
MINE SAFETY DISCLOSURE
|
Item 5. |
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
|
Item 7. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
• |
Merger Sub will merge with and into the Company, with the Company being the surviving company following the merger.
|
• |
Each issued and outstanding share of the Company common stock will automatically be converted into Class A common stock of SEPA, par value $0.0001 per share, at the Conversion Ratio (as defined in the Merger
Agreement); and
|
• |
Outstanding Company convertible securities of the Company will be assumed by SEPA and will be converted into the right to receive Class A Common Stock of SEPA.
|
• |
Do not reflect every expenditure, future requirements for capital expenditures or contractual commitments.
|
• |
Do not reflect all changes in our working capital needs.
|
• |
Do not reflect interest expense, or the amount necessary to service our outstanding debt.
|
(in thousands)
|
For the year ended
|
|||||||
2023
|
2022
|
|||||||
Net loss
|
$
|
(25,807
|
)
|
$
|
(10,293
|
)
|
||
Non-GAAP Adjustments:
|
||||||||
Interest expense
|
15,623
|
14,132
|
||||||
Depreciation and amortization
|
1,028
|
952
|
||||||
EBITDA
|
$
|
(9,156
|
)
|
$
|
4,791
|
|||
Non-GAAP Adjustments for Adjusted EBITDA:
|
||||||||
Change in fair value of derivative liabilities
|
9,621
|
(16,654
|
)
|
|||||
Other non-cash or non-recurring charges:
|
||||||||
Release of historical accrued expenses
|
(1,866
|
)
|
-
|
|||||
Shares issued for services
|
224
|
888
|
||||||
Loss on issuance of debt
|
-
|
3,434
|
||||||
Loss on extinguishment of debt
|
-
|
418
|
||||||
Adjusted EBITDA
|
$
|
(1,177
|
)
|
$
|
(7,123
|
)
|
For the Years Ended December 31,
|
Change
|
|||||||||||||||
(in thousands)
|
2023
|
2022
|
$ |
|
%
|
|||||||||||
Revenue
|
20,398
|
$
|
16,742
|
$
|
3,656
|
22
|
%
|
|||||||||
Cost of revenue
|
6,035
|
4,331
|
1,704
|
39
|
%
|
|||||||||||
Gross margin
|
14,363
|
12,411
|
1,952
|
16
|
%
|
|||||||||||
Gross margin %
|
70
|
%
|
74
|
%
|
||||||||||||
Operating expenses:
|
||||||||||||||||
General and administrative
|
8,674
|
12,556
|
(3,882
|
)
|
-31
|
%
|
||||||||||
Selling and marketing
|
4,898
|
7,474
|
(2,576
|
)
|
-34
|
%
|
||||||||||
Research and development
|
579
|
567
|
12
|
2
|
%
|
|||||||||||
Depreciation and amortization
|
752
|
766
|
(14
|
)
|
-2
|
%
|
||||||||||
Operating loss
|
(540
|
)
|
(8,952
|
)
|
8,412
|
-94
|
%
|
|||||||||
Other expense, net
|
(25,263
|
)
|
(1,339
|
)
|
(23,924
|
)
|
nm
|
|||||||||
Income tax expense
|
4
|
2
|
2
|
100
|
%
|
|||||||||||
Net loss
|
$
|
(25,807
|
)
|
$
|
(10,293
|
)
|
$
|
(15,514
|
)
|
151
|
%
|
For the years ended December 31,
|
Change
|
|||||||||||||||
2023
|
2022
|
$
|
|
%
|
||||||||||||
Interest expense
|
$
|
(15,623
|
)
|
$
|
(14,132
|
)
|
$
|
(1,491
|
)
|
11
|
%
|
|||||
Change in fair value of derivatives
|
(9,621
|
)
|
16,654
|
(26,275
|
)
|
nm
|
||||||||||
Loss on issuance of debt
|
-
|
(3,434
|
)
|
3,434
|
-100
|
%
|
||||||||||
Gain/(loss) on extinguishment of debt
|
-
|
(418
|
)
|
418
|
nm
|
|||||||||||
Other expense
|
(19
|
)
|
(9
|
)
|
(10
|
)
|
nm
|
|||||||||
Other expense, net
|
$
|
(25,263
|
)
|
$
|
(1,339
|
)
|
$
|
(23,924
|
)
|
nm
|
||||||
nm - not meaningful
|
For the period ended December 31,
|
||||||||
(in thousands)
|
2023
|
2022
|
||||||
Cash flows used by operating activities
|
$
|
(4,538
|
)
|
$
|
(17,169
|
)
|
||
Cash flows provided by investing activities
|
$
|
21
|
$
|
332
|
||||
Cash flows provided by financing activities
|
$
|
5,211
|
$
|
17,384
|
Page
|
|
Consolidated Financial Statements
|
|
F-1
|
|
F-3
|
|
F-4
|
|
F-5
|
|
F-6
|
|
F-7
|
◾
|
We obtained an understanding of the design of the Company's controls over valuation of financial instruments, including controls over management's review of the valuation
models, and the significant assumptions used in determining the fair value of the financial instruments.
|
◾
|
With assistance of our valuation specialists, we audited the fair value of the embedded conversion options and warrant liability, valuation methodology, and key
assumptions used in determining the fair value of the embedded conversion options and warrant liability by:
|
a.
|
Evaluating the appropriateness of the valuation models and techniques used in determining the fair value;
|
b.
|
Assessing the reasonableness of the significant valuation inputs, including the probability weighted expected value considering the merger agreement with SEPA Acquisition
Corp. (“SEPA”), the risk adjusted expected exchange ratio, the value of SEPA’s Class A common stock, the expected timing of the closing of the merger, and the probability of the merger closing;
|
c.
|
Assessing that the significant valuation assumption inputs, in the Black Scholes valuation model, of the discounted stock price and implied volatility are consistent with
those that would be used by market participants through the testing of source information; and
|
d.
|
Checking the mathematical accuracy of the calculation, developing independent estimates and comparing to those selected by management, where applicable, and recalculating
management’s fair value, verifying it was reasonable.
|
◾
|
We audited the completeness and accuracy of the underlying data supporting the significant valuation assumption inputs.
|
ITEM 1.
|
FINANCIAL STATEMENTS
|
(In thousands, except share data) |
2023
|
2022
|
||||||
ASSETS
|
||||||||
Current Assets:
|
||||||||
Cash
|
$
|
|
$
|
|
||||
Accounts receivable, net of allowance of $
|
|
|
||||||
Inventory
|
|
|
||||||
Prepaid expenses and other current assets
|
|
|
||||||
Total Current Assets
|
|
|
||||||
Non-Current Assets:
|
||||||||
Property, equipment and right of use assets, net
|
|
|
||||||
Intangible assets, net
|
|
|
||||||
Goodwill
|
|
|
||||||
Total Non-Current Assets
|
||||||||
Total Assets
|
$
|
|
$
|
|
||||
|
||||||||
LIABILITIES
|
||||||||
Current Liabilities:
|
||||||||
Senior secured debt, in default
|
$
|
|
$
|
|
||||
Convertible promissory notes payable
|
|
|
||||||
Convertible promissory notes payable, related parties
|
|
|
||||||
Asset-backed secured promissory notes payable
|
||||||||
Asset-backed secured promissory notes payable, related parties
|
||||||||
Accounts payable
|
||||||||
Accrued expenses
|
|
|
||||||
Factoring liabilities
|
|
|
||||||
Warrant liability
|
|
|
||||||
Accrued interest
|
|
|
||||||
Accrued interest, related parties
|
|
|
||||||
Current portion of contract liabilities
|
|
|
||||||
Other
|
|
|
||||||
Total Current Liabilities
|
|
|
||||||
Non-Current Liabilities:
|
||||||||
Lease liabilities
|
|
|
||||||
Contract liabilities |
||||||||
Total Non-Current Liabilities
|
|
|
||||||
Total Liabilities
|
$
|
|
$
|
|
||||
|
||||||||
Commitments and Contingencies (Footnote 21)
|
||||||||
|
||||||||
STOCKHOLDERS’ DEFICIT
|
||||||||
Preferred stock, par value $
|
$ |
$
|
|
|||||
Common stock, par value $
|
|
|
||||||
Additional paid-in capital
|
|
|
||||||
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||
Accumulated other comprehensive loss
|
(
|
)
|
(
|
)
|
||||
Total Stockholders’ Deficit
|
(
|
)
|
(
|
)
|
||||
Total Liabilities and Stockholders’ Deficit
|
$
|
|
$
|
|
(In thousands, except share and per share data) |
2023
|
2022
|
||||||
Revenue
|
$
|
|
$
|
|
||||
Cost of revenues
|
|
|
||||||
Gross Margin
|
|
|
||||||
|
||||||||
Operating Expenses:
|
||||||||
General and administrative
|
|
|
||||||
Selling and marketing
|
|
|
||||||
Research and development
|
|
|
||||||
Depreciation and amortization
|
|
|
||||||
Total Operating Expenses
|
|
|
||||||
|
||||||||
Operating Loss
|
(
|
)
|
(
|
)
|
||||
|
||||||||
Other Income (Expense)
|
||||||||
Interest expense
|
(
|
)
|
(
|
)
|
||||
Interest expense, related party
|
(
|
)
|
(
|
)
|
||||
Change in fair value of derivative liabilities
|
(
|
)
|
|
|||||
Loss on issuance of debt
|
|
(
|
)
|
|||||
Loss on extinguishment of debt
|
|
(
|
)
|
|||||
Other expense
|
( |
) | ( |
) | ||||
Total Other Expense
|
(
|
)
|
(
|
)
|
||||
|
||||||||
Net Loss Before Income Taxes
|
(
|
)
|
(
|
)
|
||||
|
||||||||
Income tax expense
|
|
|
||||||
|
||||||||
Net Loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
|
||||||||
Other Comprehensive Loss
|
||||||||
Foreign currency translation adjustments
|
(
|
)
|
|
|||||
Total Comprehensive Loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
|
||||||||
Loss per Share:
|
||||||||
Net loss per share, basic and diluted
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Weighted average shares outstanding, basic and diluted
|
|
|
Common Stock
|
||||||||||||||||||||||||
|
Shares Issued and
Outstanding |
Par Value
|
Additional Paid-
in Capital
|
Accumulated
Deficit
|
Accumulated Other Comprehensive
Loss
|
Total | ||||||||||||||||||
Balances as of December 31, 2021
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
||||||||||
Cashless warrant exercise
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Warrant exercise
|
||||||||||||||||||||||||
Shares issued in conjunction with senior note
|
||||||||||||||||||||||||
Shares issued for settlement of debt and warrants
|
||||||||||||||||||||||||
Shares issued for services
|
||||||||||||||||||||||||
Net loss
|
-
|
|
|
(
|
)
|
|
(
|
)
|
||||||||||||||||
Foreign currency translation adjustment
|
-
|
|
|
|
|
|
||||||||||||||||||
Balances as of December 31, 2022
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
||||||||||
Shares issued for services
|
$ | $ | $ | $ | $ | |||||||||||||||||||
Shares issued for settlement of August 2022 debt
|
||||||||||||||||||||||||
Shares issued for settlement of November 2022 debt
|
||||||||||||||||||||||||
Net loss
|
-
|
|
|
(
|
)
|
|
(
|
)
|
||||||||||||||||
Foreign currency translation adjustment
|
-
|
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||||
Balance as of December 31, 2023
|
|
$ |
|
$ |
|
$ |
(
|
)
|
$ |
(
|
)
|
$ |
(
|
)
|
(In thousands)
|
2023
|
2022
|
||||||
Cash Flows - Operating Activities:
|
||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Adjustments to reconcile net loss to net cash used by operating activities
|
||||||||
Depreciation and amortization
|
|
|
||||||
Bad debt expense
|
|
|
||||||
Shares issued for services
|
|
|
||||||
Gain/loss on extinguishment of debt
|
|
|
||||||
Income tax expense
|
|
|
||||||
Change in fair value of derivative liabilities
|
|
(
|
)
|
|||||
Loss on issuance of debt
|
|
|||||||
Amortization of debt issuance and debt discounts
|
|
|
||||||
Changes in operating assets and liabilities
|
||||||||
Accounts receivable
|
(
|
)
|
(
|
)
|
||||
Inventory, prepaid expenses and other assets
|
( |
) | ( |
) | ||||
Accounts payable
|
|
(
|
)
|
|||||
Accrued interest and accrued interest, related parties
|
||||||||
Accrued expenses and contract liabilities
|
( |
) | ||||||
Net Cash Used by Operating Activities
|
(
|
)
|
(
|
)
|
||||
|
||||||||
Cash Flows - Investing Activities
|
||||||||
Proceeds from sale of property and equipment
|
|
|
||||||
Net Cash Flows Provided by Investing Activities
|
|
|
||||||
|
||||||||
Cash Flows - Financing Activities
|
||||||||
Proceeds from convertible promissory notes
|
|
|
||||||
Proceeds from asset-backed secured promissory notes payable
|
|
|||||||
Proceeds from senior secured promissory note
|
|
|
||||||
(Payments)/Proceeds from factoring
|
(
|
)
|
||||||
Proceeds from warrant exercises
|
|
|
||||||
Proceeds from short term borrowings
|
||||||||
Repayments of debt principal
|
|
(
|
)
|
|||||
Principal payments on finance leases
|
( |
) | ( |
) | ||||
Net Cash Flows Provided by Financing Activities
|
|
|
||||||
|
||||||||
Effect of Exchange Rates on Cash
|
(
|
)
|
(
|
)
|
||||
|
||||||||
Net Change in Cash During Period
|
|
|
||||||
|
||||||||
Cash at Beginning of Period
|
|
|
||||||
Cash at End of Period
|
$
|
|
$
|
|
||||
|
||||||||
Supplemental Information:
|
||||||||
Cash paid for interest
|
$
|
|
$
|
|
||||
Non-Cash Investing and Financing Activities:
|
||||||||
Warrants issued in conjunction with senior secured promissory note payable and convertible promissory notes
payable
|
$ |
$ |
||||||
Conversion of convertible notes payable and accrued interest to common stock
|
|
|
||||||
Embedded conversion feature on convertible debt
|
||||||||
Common shares issued for advisory shares
|
|
|
||||||
Settlement of debt and warrants with stock
|
||||||||
Common shares issued in conjunction with senior secured debt
|
||||||||
Warrant issuance in conjunction with convertible notes
|
||||||||
Reclassification of warrant liabilities to equity due to cashless warrant exercise
|
||||||||
Working capital balances refinanced into convertible notes payable
|
1.
|
Nature of the Business and Basis of Presentation
|
2. |
Going Concern
|
3. |
Summary of Significant Accounting Policies
|
Level 1 – Observable inputs that reflect quoted prices (unadjusted) in active markets for identical assets and liabilities:
|
Level 2 – Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly: and
|
Level 3 – Unobservable inputs that are not corroborated by market data, therefore requiring the Company to develop its own assumptions.
|
4. |
Merger Agreement
|
• |
Merger Sub will merge with and into the Company, with the Company being the surviving company following the merger.
|
• |
Each issued and outstanding share of the Company’s common stock, will automatically be converted into Class A common stock of SEPA, par value $
|
• |
Outstanding convertible securities of the Company will be assumed by SEPA and will be converted into the right to receive Class A Common Stock of SEPA.
|
5. |
Loss per Share
|
(in thousands)
|
December 31, 2023
|
December 31, 2022
|
||||||
Common shares
|
|
|
||||||
Common shares issuable assuming exercise of nominally priced warrants
|
|
|
||||||
Weighted Average Shares Outstanding
|
|
|
(in thousands)
|
December 31, 2023
|
December 31, 2022
|
||||||
Common stock options
|
|
|
||||||
Common stock purchase warrants
|
|
|
||||||
Convertible notes payable, including interest
|
|
|
||||||
|
|
|
6. |
Inventory
|
(in thousands) |
December 31, 2023
|
December 31, 2022
|
||||||
Finished goods
|
$
|
|
$
|
|
||||
Parts and accessories
|
|
|
||||||
Reserve for slow moving inventory |
( |
) | ( |
) | ||||
Total Inventory
|
$
|
|
$
|
|
7. |
Intangible Assets
|
December 31, 2023
|
December 31, 2022
|
Weighted-
Average Useful
Life (in years)
|
||||||||||||||||||
(in thousands)
|
Gross
|
Accumulated
Amortization
|
Gross
|
Accumulated
Amortization
|
||||||||||||||||
Definite-lived Intangibles
|
||||||||||||||||||||
Customer relationships
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
(
|
)
|
|
|||||||||
Patent
|
|
(
|
)
|
|
(
|
)
|
|
|||||||||||||
Tradenames
|
|
(
|
)
|
|
(
|
)
|
|
|||||||||||||
Intangible Assets
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
(
|
)
|
|
Year ended December 31,
|
Amortization
|
|||
2024
|
|
|||
2025
|
|
|||
2026
|
|
|||
2027
|
|
|||
2028
|
|
|||
Thereafter |
8. |
Accrued Expenses
|
(in thousands)
|
December 31, 2023
|
December 31, 2022
|
||||||
Registration penalties
|
$
|
|
$
|
|
||||
License fees
|
|
|
||||||
Board of directors fees
|
|
|
||||||
Employee compensation
|
|
|
||||||
Other
|
|
|
||||||
Total Accrued Expenses
|
$
|
|
$
|
|
9. |
Factoring Liabilities
|
(In thousands)
|
December 31, 2023
|
December 31, 2022
|
||||||
Receivables transferred
|
$
|
|
$
|
|
||||
Reserve amount held
|
(
|
)
|
(
|
)
|
||||
Factoring liability
|
$
|
|
$
|
|
10.
|
Senior Secured Debt, in Default
|
December 31, 2023
|
December 31, 2022
|
|||||||||||||||||||||||
(In thousands)
|
Principal
|
Debt
Discount
|
Carrying
Value
|
Principal
|
Debt
Discount
|
Carrying
Value
|
||||||||||||||||||
Senior secured debt
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
11. | Convertible Promissory Notes and Convertible Promissory Notes, Related Parties |
December 31, 2023
|
||||||||||||||||||||
(In thousands, except conversion price)
|
Conversion
Price
|
Principal
|
Debt
Discount
|
Conversion
Option
|
Carrying
Value
|
|||||||||||||||
Acquisition convertible promissory note, in default
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||||
Convertible promissory note, related party, in default
|
$
|
|
|
|
|
|
||||||||||||||
2022 Convertible notes payable
|
$
|
|
|
(
|
)
|
|
|
|||||||||||||
2022 Convertible notes payable, related parties
|
$
|
|
|
(
|
)
|
|
|
|||||||||||||
Total Convertible promissory notes
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
|
December 31, 2022
|
||||||||||||||||||||
(In thousands, except conversion price)
|
Conversion
Price
|
Principal
|
Debt
Discount
|
Conversion
Option
|
Carrying
Value
|
|||||||||||||||
Acquistion convertible promissory note, in default
|
$
|
|
$
|
|
|
$
|
|
|||||||||||||
Convertible promissory note payable, related parties, in default
|
$
|
|
|
|
|
|
||||||||||||||
2022 Convertible notes payable
|
$
|
|
|
(
|
)
|
|
|
|||||||||||||
2022 Convertible notes payable, related parties |
$ |
( |
) | |||||||||||||||||
Total Convertible Promissory Notes
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
|
12. |
Asset-Backed Secured Promissory
Notes
|
December 31, 2023
|
||||||||||||||||
(In thousands)
|
Principal
|
Debt
Discount
|
Embedded
Derivative
|
Carrying
Value
|
||||||||||||
ABS promissory notes
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
|
|||||||
ABS promissory notes, related parties
|
|
(
|
)
|
|
|
|||||||||||
Total ABS Promissory Notes
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
|
13. | Fair Value Measurements |
Fair value measurement at December 31, 2023
|
||||||||||||||||
(in thousands) |
Fair value
|
Quoted
prices in
active
markets
(Level 1)
|
Significant
other
observable
inputs
(Level 2)
|
Significant
unobservable inputs
(Level 3)
|
||||||||||||
Warrant liability
|
$
|
|
|
|
$
|
|
||||||||||
Conversion option
|
|
|
|
|
||||||||||||
Total Fair Value
|
$
|
|
$
|
|
$
|
|
$
|
|
Fair value measurement at December 31, 2022
|
||||||||||||||||
(in thousands) |
Fair value
|
Quoted
prices in
active
markets
(Level 1)
|
Significant
other
observable
inputs
(Level 2)
|
Significant
unobservable
inputs
(Level 3)
|
||||||||||||
Warrant liability
|
$
|
|
|
|
$
|
|
||||||||||
Conversion option
|
|
|
|
|
||||||||||||
Total Fair Value
|
$
|
|
$
|
|
$
|
|
$
|
|
Initial Valuation
May 2023 Issuance
|
December 31, 2022
|
|||||||
Weighted average expected life in years
|
|
|
||||||
Weighted average volatility
|
|
%
|
|
%
|
||||
Value of underlying shares | $ | $ | ||||||
Weighted average risk free interest rate
|
|
%
|
|
%
|
||||
Expected dividend yield
|
|
|
(in thousands, except per share data) |
Warrants
Outstanding
|
Fair Value
per Share
|
Warrant Liability
Fair Value
|
|||||||||
Balance December 31, 2021 |
$ | $ | ||||||||||
Cashless exercise |
( |
) | ( |
) | ||||||||
Issuance of warrants classified as liablities |
||||||||||||
Change in fair value
|
-
|
- |
(
|
)
|
||||||||
Balance December 31, 2022
|
|
$
|
|
$
|
|
|||||||
Warrants exercised
|
|
|
|
|||||||||
Issuance of warrants classified as liablities
|
|
|
|
|||||||||
Change in fair value
|
-
|
- |
|
|||||||||
Balance December 31, 2023
|
|
$
|
|
$
|
|
Initial Valuation
May 2023 Issuance
|
December 31, 2022 |
|||||||
Conversion price (1)
|
$ |
$
|
|
|||||
Value of underlying shares
|
$ |
$
|
|
|||||
Interest Rate (annual) (2)
|
% |
|
%
|
|||||
Volatility (annual) (3)
|
% |
|
%
|
|||||
Time to maturity
|
|
(1) |
|
(2) |
|
(3) |
|
(in thousands) |
Conversion
Liability
|
|||
Balance December 31, 2021
|
$
|
|
||
Issuance of Convertible Notes
|
|
|||
Settlement of convertible notes
|
( |
) | ||
Change in fair value
|
(
|
)
|
||
Balance December 31, 2022
|
$
|
|
||
Issuance of Convertible Notes
|
(
|
)
|
||
Change in fair value
|
(
|
)
|
||
Balance December 31, 2023
|
$
|
|
14. |
Contract Liabilities
|
Year Ended December 31,
|
||||||||
(in thousands)
|
2023
|
2022
|
||||||
Beginning balance
|
$
|
|
$
|
|
||||
New service agreements
|
|
|
||||||
Revenue recognized
|
(
|
)
|
(
|
)
|
||||
Total Contract Liabilities
|
$
|
|
$
|
|
15. |
Common Stock Purchase Warrants
|
(in thousands, except per share data) |
Warrants
|
Weighted
Average
Exercise Price
|
Weighted
Average
Remaining
Life
|
|||||||||
Warrants at December 31, 2021
|
|
$
|
|
|||||||||
Issuances
|
|
|
||||||||||
Exercised
|
(
|
)
|
|
|||||||||
Forfeited or expired
|
|
|
||||||||||
Outstanding at December 31, 2022
|
|
$
|
|
|
||||||||
Issuances
|
|
|
||||||||||
Exercised
|
|
|
||||||||||
Forfeited or expired
|
(
|
)
|
|
|||||||||
Outstanding at December 31, 2023
|
|
$
|
|
16. |
Common Stock
|
17. |
Concentration of Credit Risk and Limited Suppliers
|
Year ended December 31, | ||||||||
2023
|
2022 | |||||||
Purchases:
|
||||||||
Vendor A
|
|
%
|
|
%
|
||||
Vendor B
|
|
%
|
|
%
|
18. |
Revenue
|
|
Year ended December 31, 2023
|
Year ended December 31, 2022
|
||||||||||||||||||||||
|
United States
|
International
|
Total
|
United States
|
International
|
Total
|
||||||||||||||||||
Consumables and parts revenue
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||||||
System revenue
|
|
|
|
|
|
|
||||||||||||||||||
License fees and other
|
|
|
|
|
|
|
||||||||||||||||||
Product Revenue
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||||||
Rental Income |
||||||||||||||||||||||||
Total Revenue |
$ |
$ |
$ |
$ |
$ |
$ |
19. |
Stock-Based Compensation
|
20. |
Income
Taxes
|
Year ended December 31, |
||||||||
(In thousands) |
2023
|
2022
|
||||||
Domestic
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Foreign
|
(
|
)
|
(
|
)
|
||||
Net loss before income taxes
|
$
|
(
|
)
|
$
|
(
|
)
|
(In thousands)
|
December 31, 2023
|
December 31, 2022
|
||||||
Current: | ||||||||
Federal
|
$
|
|
$
|
|
||||
State
|
|
|
||||||
Foreign
|
|
|
||||||
Current Tax Provision |
$
|
|
$
|
|
||||
Deferred:
|
||||||||
Federal
|
$
|
(
|
)
|
$
|
(
|
)
|
||
State
|
(
|
)
|
|
|||||
Foreign
|
(
|
)
|
(
|
)
|
||||
Change in valuation allowance
|
|
|
||||||
Deferred Tax Provision |
$
|
|
$
|
|
(In thousands) | Years ended December 31, |
|||||||
|
2023
|
2022
|
||||||
Tax benefit at statutory rate
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Increase (reduction) in income taxes resulting from:
|
||||||||
State income tax benefits, net of federal benefit
|
(
|
)
|
(
|
)
|
||||
Non-deductible gain on warrant adjustment valuation
|
|
(
|
)
|
|||||
Change in valuation allowance
|
|
|
||||||
Registration penalties
|
||||||||
Other
|
(
|
)
|
|
|||||
Income Tax Expense
|
$
|
|
$
|
|
(In thousands) |
December 31, 2023
|
December 31, 2022
|
||||||
Deferred Tax Assets
|
||||||||
Net operating loss carryforwards
|
$
|
|
$
|
|
||||
Net operating loss carryforwards - foreign
|
|
|
||||||
Excess of tax basis over book value of property and equipment
|
|
|
||||||
Excess of tax basis over book value of intangible assets
|
|
|
||||||
Lease liability
|
||||||||
Stock-based compensation
|
|
|
||||||
Accrued employee compensation
|
|
|
||||||
Capitalized equity costs
|
|
|
||||||
Capitalized research and development
|
||||||||
Net change in reserve accounts
|
|
|
||||||
Gross deferred tax asset
|
|
|
||||||
Valuation Allowance
|
(
|
)
|
(
|
)
|
||||
Net Deferred Tax Asset
|
|
|
||||||
Deferred Tax Liabilities | ||||||||
Right-of-use asset
|
( |
) | ( |
) | ||||
Gross deferred tax liability | ( |
) | ( |
) | ||||
TOTAL | $ | $ |
21. |
Commitments and Contingencies
|
(In thousands)
|
Operating
Leases |
Finance
Leases
|
||||||
Year ended December 31,
|
||||||||
2024
|
$
|
|
$
|
|
||||
2025
|
|
|
||||||
2026
|
|
|
||||||
2027
|
|
|||||||
2028
|
|
|||||||
Total Lease Payments
|
|
|
22. |
Subsequent Event
|
Item 9. |
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
|
Item 9A. |
CONTROLS AND PROCEDURES
|
1. |
Expertise and resources to analyze and properly apply U.S. GAAP to complex and non-routine transactions such as complex financial instruments and derivatives and complex sales distributing agreements with
select vendors.
|
2. |
A lack of internal resources to analyze and properly apply U.S. GAAP to accounting for financial instruments included in service agreements with select vendors.
|
3. |
The Company has failed to design and implement controls around all accounting and IT processes and procedures and, as such, we believe that all its accounting and IT processes and procedures need to be
re-designed and tested for operating effectiveness.
|
Name
|
Age
|
Position Held
|
||
Morgan Frank
|
52
|
Chief Executive Officer, Chairman of the Board
|
||
Toni Rinow
|
59
|
Chief Financial Officer
|
||
Peter Stegagno
|
64
|
Chief Operating Officer
|
||
Iulian Cioanta, PhD
|
61
|
Chief Science and Technology Officer
|
||
Andrew Walko
|
39
|
President
|
||
Tim Hendricks
|
49
|
Executive Vice President of Sales
|
||
A. Michael Stolarski
|
53
|
Director
|
||
Jeff Blizard
|
55
|
Director
|
||
Ian Miller
|
48
|
Director
|
||
James Tyler
|
66
|
Director
|
||
Kevin A. Richardson, II
|
55
|
Director, Chief Strategy Officer
|
• |
Morgan Frank, Chief Executive Officer
|
• |
Toni Rinow, Chief Financial Officer
|
• |
Tim Hendricks, Executive Vice President of Sales
|
• |
Kevin A. Richardson, II, Chief Strategy Officer and former Chief Executive Officer
|
Name and Position
|
Year
|
Salary
|
Bonus (2)
|
All other
compensation (1)
|
Total
|
||||||||||||
Morgan Frank, Chief Executive Officer
|
2023
|
1
|
-
|
100,000
|
100,001
|
||||||||||||
Toni Rinow, Chief Financial Officer
|
2023
|
335,000
|
-
|
-
|
335,000
|
||||||||||||
Tim Hendricks, Executive Vice President of Sales
|
2023
|
244,391
|
30,000
|
49,067
|
323,458
|
||||||||||||
Kevin Richardson II, Former Chief Executive Officer
|
2023
|
350,000
|
-
|
60,000
|
410,000
|
||||||||||||
|
2022
|
430,583
|
-
|
175,000
|
605,583
|
(1) |
Includes board fees, health, dental, life and disability insurance premiums and 401(k) matching contributions.
|
(2) |
The bonus paid to Mr. Hendricks in 2023 was a signing bonus.
|
Name
|
Number of
securities
underlying
unexercised
options
exercisable
|
Number of
securities
underlying options
unexercisable
|
Equity incentive
plan awards
number of
securities
underlying
unexercised
unearned options
|
Exercise
price ($)
|
Expiration
Date
|
||||||||||||
Kevin A. Richardson, Former Chief Executive Officer
|
452,381
|
-
|
-
|
$
|
0.11
|
10/1/2025
|
|||||||||||
297,619
|
-
|
-
|
$
|
0.06
|
10/1/2025
|
||||||||||||
700,000
|
-
|
-
|
$
|
0.04
|
6/16/2026
|
||||||||||||
594,300
|
-
|
-
|
$
|
0.18
|
11/9/2026
|
||||||||||||
900,000
|
-
|
-
|
$
|
0.11
|
6/14/2027
|
||||||||||||
1,100,000
|
-
|
-
|
$
|
0.21
|
9/20/2028
|
||||||||||||
50,000
|
-
|
-
|
$
|
0.15
|
8/26/2029
|
Director
|
Fee Earned or
paid in cash
(in thousands)
|
|||
Morgan Frank
|
$
|
100
|
||
A. Michael Stolarski
|
$
|
97
|
||
Jeff Blizzard
|
$
|
90
|
||
Ian Miller
|
$
|
90
|
||
James Tyler
|
$
|
90
|
||
Kevin Richardson
|
$
|
60
|
Item 12.
|
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
|
Name of Beneficial Owner (1)
|
Number of
Share
Beneficially
Owned
|
Percent of
Shares
Outstanding (2)
|
||||||
Morgan Frank (4)
|
347,483,770
|
25.6
|
%
|
|||||
Toni Rinow
|
-
|
*
|
||||||
Timothy Hendricks
|
-
|
*
|
||||||
Kevin A. Richardson, II (3)
|
35,459,229
|
3.1
|
%
|
|||||
A. Michael Stolarski
|
132,990,790
|
10.9
|
%
|
|||||
James Tyler
|
3,262,500
|
*
|
||||||
Ian Miller
|
17,364,814
|
1.5
|
%
|
|||||
Jeff Blizard
|
-
|
*
|
||||||
All Directors and Executives as a group (11 persons)
|
543,085,371
|
37.2
|
%
|
|||||
Greater than 5% Holders:
|
||||||||
Opaleye LP
|
207,514,881
|
19.8
|
%
|
|||||
Manchester Management PR, LLC
|
||||||||
Manchester Management Company, LLC
|
||||||||
Manchester Explorer, L.P.
|
||||||||
James E. Besser
|
362,858,770
|
26.7
|
%
|
Plan category
|
Number of
securities to be
issued upon
exercise of
outstanding
options, warrants,
and rights (a)
|
Weighted-
average
exercise price
of outstanding
options,
warrants and
rights (b)
|
Number of
securities
remaining
available for
future issuance
under equity
compensation
plans (c)
|
|||||||||
Equity compensation plans approved by security holders
|
-
|
$
|
-
|
-
|
||||||||
Equity compensation plans not approved by security holders
|
16,286,650
|
0.28
|
5,598,216
|
|||||||||
Total
|
16,286,650
|
$
|
0.28
|
5,598,216
|
(In thousands)
|
For the Year Ended December 31,
|
|||||||
Fee Category
|
2023
|
2022
|
||||||
Audit fees
|
$
|
545 |
$
|
504
|
||||
Tax fees
|
-
|
-
|
||||||
Audit related fees
|
-
|
-
|
||||||
All other fees
|
-
|
-
|
||||||
Total Fees
|
$
|
545
|
$
|
504
|
• |
Audit fees consist of fees for the annual audit of our consolidated financial statements, the review of the interim financial statements included in our quarterly reports on Form 10-Q, and other
professional services provided in connection with statutory and regulatory filings and consents related to capital markets transactions and engagements for those fiscal years.
|
• |
Tax fees consist of fees for tax compliance, tax advice and tax planning services for those fiscal years.
|
• |
Audit related fees consist of fees for assurance and related services that are reasonably related to the performance of the audit or review.
|
• |
All other fees consist of fees for all other products and services.
|
Page
|
|
Consolidated financial statements
|
|
Report of Independent Registered Public Accounting Firm (PCAOB ID: 688)
|
F-1
|
Consolidated Balance Sheets as of December 31, 2023 and 2022
|
F-3
|
Consolidated Statements of Comprehensive Loss for the years ended December 31, 2023 and 2022
|
F-4
|
Consolidated Statements of Stockholders’ Deficit for the years ended December 31, 2023 and 2022
|
F-5
|
Consolidated Statements of Cash Flows for the years ended December 31, 2023 and 2022
|
F-5
|
Notes to Consolidated Financial Statements
|
F-7
|
Exhibit No.
|
Description
|
Agreement and Plan of Merger, dated as of August 23, 2023, by and among SEP Acquisition Corp., SEP Acquisition Holdings Inc., and SANUWAVE Health, Inc. (Incorporated by reference to Exhibit
2.1 to the Form 8-K filed with the SEC on August 23, 2023).
|
|
Amendment Number one to Agreement and Plan of Merger, dated February 27, 2024, by and between SEP Acquisition Corp. and Sanuwave Health, Inc. (Incorporated by reference to Exhibit 2.1 to
the Form 8-K filed with the SEC on February 27, 2024)
|
|
Articles of Incorporation (Incorporated by reference to Exhibit 3.1 to the Form 10-SB filed with the SEC on December 18, 2007).
|
|
Certificate of Amendment to the Articles of Incorporation (Incorporated by reference to Appendix A to the Definitive Schedule 14C filed with the SEC on October 16, 2009).
|
|
Certificate of Amendment to the Articles of Incorporation (Incorporated by reference to Exhibit A to the Definitive Schedule 14C filed with the SEC on April 16, 2012).
|
|
Bylaws (Incorporated by reference to Exhibit 3.02 to the Form 10-SB filed with the SEC on December 18, 2007).
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock of the Company dated March 14, 2014 (Incorporated by reference to Exhibit 3.1 to
the Form 8-K filed with the SEC on March 18, 2014).
|
|
Certificate of Amendment to the Articles of Incorporation, dated September 8, 2015 (Incorporated by reference to Exhibit 3.6 to the Form 10-K filed with the SEC on March 30, 2016).
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock of the Company dated January 12, 2016 (Incorporated by reference to Exhibit 3.1 to
the Form 8-K filed with the SEC on January 19, 2016).
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock of the Company dated January 31, 2020 (Incorporated by reference to Exhibit 3.1 to
the Form 8-K filed with the SEC on February 6, 2020).
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock of the Company dated January 31, 2020 (Incorporated by reference to Exhibit 3.1 to
the Form 8-K filed with the SEC on February 6, 2020).
|
|
Certificate of Designation of Series D Convertible Preferred Stock (Incorporated by reference to Exhibit 3.1 to the Form 8-K filed with the SEC on May 20, 2020).
|
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Certificate of Amendment of the Articles of Incorporation (Incorporated by reference to Exhibit 3.1 to the Form 8-K filed with the SEC on January 5, 2021).
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Certificate of Amendment of the Articles of Incorporation, dated January 31, 2023 (Incorporated by reference to Exhibit 3.12 to the Form S-1/A filed with the SEC on January 31, 2023).
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Description of Registrant’s Common Stock (Incorporated by reference to the Company’s Form 10-K for the year ended December 31, 2021).
|
Form of Secured Promissory Note issued to NH Expansion Credit Fund Holdings LP, dated August 6, 2020 (Incorporated by reference to the Form 8-K filed with the SEC on August 12, 2020).
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|
Warrant issued to NH Expansion Credit Fund Holdings LP, dated August 6, 2020 (Incorporated by reference to the Form 8-K filed with the SEC on August 12, 2020).
|
|
Second Amendment to the Note and Warrant Purchase and Security Agreement by and between the Company and NH Expansion Credit Fund Holdings L.P., dated February 25, 2022 (Incorporated by
reference to Exhibit 10.1 to the Form 8-K filed with the SEC on March 2, 2022).
|
|
Third Amendment to the Note and Warrant Purchase and Security Agreement by and between the Company and NH Expansion Credit Fund Holdings L.P., dated June 30, 2022 (Incorporated by reference
to Exhibit 10.1 to the Form 8-K filed with the SEC on July 7, 2022).
|
|
Fourth Amendment to the Note and Warrant Purchase and Security Agreement by and between the Company and NH Expansion Credit Fund Holdings L.P., dated June 23, 2023 (Incorporated by
reference to Exhibit 10.1 to the Form 8-K filed with the SEC on June 29, 203).
|
|
Fifth Amendment to the Note and Warrant Purchase and Security Agreement by and between the Company and NH Expansion Credit Fund Holdings L.P., dated March 6, 2024 (Incorporated by reference
to Exhibit 10.1 to the Form 8-K filed with the SEC on March 6, 2024).
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Convertible Promissory Note issued to HealthTronics, Inc., dated August 6, 2020 (Incorporated by reference to Exhibit 10.7 to the Form 8-K filed with the SEC on August 12, 2020).
|
|
Amendment to certain Promissory Notes that were dated August 1, 2005, by and among the Company, SANUWAVE, Inc. and HealthTronics, Inc., dated June 15, 2015 (Incorporated by reference to
Exhibit 10.1 to the Form 8-K filed with the SEC on June 18, 2015.)
|
|
Second Amendment to Certain Promissory Notes entered into as of June 28, 2016, by and among the Company, SANUWAVE, Inc. and HealthTronics, Inc. (Incorporated by reference to Exhibit 10.1 to
the Form 10-Q filed with the SEC on August 15, 2016).
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|
Third Amendment to promissory notes entered into as of August 3, 2017, by and among the Company, SANUWAVE, Inc. and HealthTronics, Inc. (Incorporated by reference to Exhibit 10.1 to the
Form 8-K filed with the SEC on August 4, 2017).
|
|
Securities Purchase Agreement by and between the Company and HealthTronics, Inc., dated August 6, 2020 (Incorporated by reference to Exhibit 10.8 to the Form 8-K filed with the SEC on
August 12, 2020).
|
|
Convertible Promissory Note issued to Celularity Inc., dated August 6, 2020 (Incorporated by reference to Exhibit 10.3 to the Form 8-K filed with the SEC on August 12, 2020).
|
|
Common Stock Purchase Warrant, dated as of June 5, 2020, issued by the Company to LGH Investments, LLC (Incorporated by reference to Exhibit 10.3 to the Form 8-K filed with the SEC on June
11, 2020).
|
|
Form of Warrant Issued September 27, 2021, and December 22, 2021 (Incorporated by reference to Exhibit 10.7 filed with the Form 10-Q for the quarter ended September 30, 2021).
|
|
Form of Common Stock Purchase Warrant issued to certain purchasers, dated August 5, 2022 (Incorporated by reference to Exhibit 4.2 to the Form 8-K filed with the SEC on August 8, 2022).
|
|
Form of Common Stock Purchase Warrant issued to certain purchasers, dated November 14, 2022 (Incorporated by reference to Exhibit 4.4 to the Form S-1/A filed with the SEC on January 31,
2023).
|
Form of Future Advance convertible Promissory note issued to certain purchasers, date December 30, 2023 (Incorporated by reference to Exhibit 4.1 the Company’s Form 8-K filed with the SEC
on January 3, 2024).
|
Forms of Common Stock purchase Warrants issued to certain purchasers, dated December 30, 2023 (Incorporated by reference to Exhibit 4.2 the Company’s Form 8-K filed with the SEC on January
3, 2024)
|
|
Form of Asset-Backed Secured Promissory Notes issued to certain purchasers, dated July 21, 2023 (Incorporated by reference to Exhibit 4.1 the Company’s Form 8-K filed with the SEC on July
21, 2023)
|
|
Form of Future Advance Convertible Promissory Note issued to certain purchasers, dated January 21, 2024 (Incorporated by reference to Exhibit 4.1 the Company’s Form 8-K filed with the SEC
on January 21, 2024)
|
|
Form of Common Stock Purchase Warrants issued to certain purchasers, dated January 21, 2024 (Incorporated by reference to Exhibit 4.2 the Company’s Form 8-K filed with the SEC on January
21, 2024)
|
|
10.1∞
|
Amended and Restated 2006 Stock Option Incentive Plan of SANUWAVE Health, Inc. (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on November 3, 2010).
|
Security Agreement, by and between the Company and HealthTronics, Inc., dated June 15, 2015 (Incorporated by reference to Exhibit 4.1 to the Form 8-K filed with the SEC on June 18, 2015).
|
|
Letter Agreement by and between the Company and HealthTronics, Inc., dated August 6, 2020 (Incorporated by reference to Exhibit 10.6 to the Form 8-K filed with the SEC on August 12, 2020).
|
|
Amendment to Agreement for Purchase and Sale, Limited Exclusive Distribution and Royalties, and Servicing and Repairs of dermaPACE®System and Equipment, effective as of November 1, 2023, by
and between SANUWAVE and Premier Shockwave Wound Care, Inc.
|
|
Joint Venture Agreement, dated September 21, 2018, by and among the Company, Johnfk Medical Inc. and Holistic Health Institute Pte. Ltd. (Incorporated by reference to Exhibit 10.1 to the
Form 8-K filed with the SEC on September 27, 2018).
|
|
Joint Venture Agreement, dated December 13, 2019, by and among the Company, Universus Global Advisors LLC, Versani Health Consulting Consultoria Em Gestao De Negocios Eireli, and the IDIC
Group as set forth therein (Incorporated by reference to the Form 8-K filed with the SEC on January 28, 2020).
|
|
Master Equipment and Contracts Purchase Agreement by and between the Company and ABF SANUWAVE, LLC dated February 17, 2022 (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed
with the SEC on February 24, 2022).
|
|
Master Equipment Lease, dated January 26, 2018, by and among the Company and NFS Leasing, Inc. (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on February 15,
2018).
|
|
Asset Purchase Agreement by and between the Company and Celularity Inc., dated August 6, 2020 (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on August 12,
2020).
|
|
License and Marketing Agreement by and between the Company and Celularity Inc., dated August 6, 2020 (Incorporated by reference to Exhibit 10.2 to the Form 8-K filed with the SEC on August
12, 2020).
|
|
Executive Employment Agreement, effective May 23, 2023, by and between SANUWAVE and Morgan Frank (Incorporated by reference to Exhibit 10.1 to SANUWAVE’s Form 8-K filed with the SEC on May
30, 2023).
|
|
Transition and Separation Agreement, dated May 23, 2023, by and between SANUWAVE and Kevin A. Richardson, II (Incorporated by reference to Exhibit 10.2 to SANUWAVE’s Form 8-K filed with the
SEC on May 30, 2023).
|
|
Offer Letter, dated April 7, 2022, by and between the Company and Dr. Toni Rinow (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on August 19, 2022).
|
|
Offer Letter, dated July 20, 2023, by and between the Company and Andrew Walko (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on July 31, 2023).
|
Note and Warrant Purchase and Security Agreement by and among the Company, the noteholder party thereto and NH Expansion Credit Fund Holdings LP, as agent, dated August 6, 2020
(Incorporated by reference to Exhibit 10.5 to the Form 8-K filed with the SEC on August 12, 2020).
|
|
Security Agreement, dated May 9, 2023, by and among SANUWAVE and certain lenders (Incorporated by regarding to Exhibit 10.74 to SANUWAVE’s Form S-1 filed with the SEC on June 30, 2023)
|
|
Form of Securities Purchase Agreement, dated August 5, 2022, by and among the Company and the purchasers identified on the signature pages thereto (Incorporated by reference to Exhibit 10.1
the Form 8-K filed with the SEC on August 8, 2022).
|
|
Form of Registration Rights Agreement, dated August 5, 2022, by and among the Company and certain lenders (Incorporated by reference to Exhibit 10.4 to the Form 8-K filed with the SEC on
August 8, 2022).
|
|
Securities Purchase Agreement, dated November 14, 2022, by and among the Company and the purchasers identified on the signature pages thereto (Incorporated by reference to Exhibit 10.67 to
the Form S-1/A filed with the SEC on January 31, 2023).
|
|
Registration Rights Agreement, dated November 14, 2022, by and among the Company and certain lenders (Incorporated by reference to Exhibit 10.70 to the Form S-1/A filed with the SEC on
January 31, 2023).
|
|
Security Agreement dated July 21, 2023, by and among the Company and certain lenders. (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on July 21, 2023).
|
|
Subordination Agreement dated July 21, 2023, by and among the Company, NH Expansion Credit Fund Holdings LP and certain creditors. (Incorporated by reference to Exhibit 10.1 to the Form 8-K
filed with the SEC on July 21, 2023).
|
|
Side Letter dated July 21, 2023, by and among the Company and certain purchasers. (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on July 21, 2023).
|
|
Securities Purchase Agreement, dated January 21, 2024, by and among the Company and the purchasers identified on the signature pages thereto (Incorporated by reference to Exhibit 10.1 to
the Form 8-K filed with the SEC on January 21, 2024).
|
|
Security Agreement dated January 21, 2024, by and among the Company and certain lenders. (Incorporated by reference to Exhibit 10.2 to the Form 8-K filed with the SEC on January 21, 2024).
|
|
Subordination Agreement dated January 21, 2024, by and among the Company, NH Expansion Credit Fund Holdings LP and certain creditors. (Incorporated by reference to Exhibit 10.3 to the Form
8-K filed with the SEC on January 21, 2024).
|
|
Form of Registration Rights Agreement, dated January 21, 2024, by and among the Company and certain lenders (Incorporated by reference to Exhibit 10.4 to the Form 8-K filed with the SEC on
January 21, 2024).
|
|
Form of Waiver Letter, dated January 21, 2024, by and among the Company and certain purchasers (Incorporated by reference to Exhibit 10.5 to the Form 8-K filed with the SEC on January 21,
2024).
|
|
Form of Letter Agreement, dated January 21, 2024, by and among the Company and certain lenders (Incorporated by reference to Exhibit 10.6 to the Form 8-K filed with the SEC on January 21,
2024).
|
|
Securities Purchase Agreement, dated December 30, 2023, by and among the Company and the purchasers identified on the signature pages thereto (Incorporated by reference to Exhibit 10.1 to
the Form 8-K filed with the SEC on January 3, 2024)
|
|
Security Agreement, dated December 30, 2023, by and among the Company and certain lenders (Incorporated by reference to Exhibit 10.2 to the Form 8-K filed with the SEC on January 3, 2024)
|
|
Subordination Agreement, dated December 30, 2023, by and among the Company, NH Expansion Credit Fund Holdings LP and certain creditors (Incorporated by reference to Exhibit 10.3 to the Form
8-K filed with the SEC on January 3, 2024)
|
Registration Rights Agreement, dated December 30, 2023, by and among the Company and certain lenders (Incorporated by reference to Exhibit 10.4 to the Form 8-K filed with the SEC on January
3, 2024)
|
|
Form of waiver letter with purchasers in December 2023 offering (Incorporated by reference to Exhibit 10.5 to the Form 8-K filed with the SEC on January 3, 2024)
|
|
Form of letter agreement with purchasers in December 2023 offering (Incorporated by reference to Exhibit 10.6 to the Form 8-K filed with the SEC on January 3, 2024)
|
|
Form of Voting Agreement, dated as of August 23, 2023, by and among SEP Acquisition Corp., SANUWAVE Health, Inc., and the stockholder of SANUWAVE Health, Inc. party thereto (Incorporated by
reference to Exhibit 10.1 to the Form 8-K filed with the SEC on August 23, 2023).
|
|
Sponsor Voting Agreement, dated as of August 23, 2023, by and among Mercury Sponsor Group I LLC, SEP Acquisition Corp., and SANUWAVE Health, Inc. (Incorporated by reference to Exhibit 10.2 to the Form 8-K filed
with the SEC on August 23, 2023).
|
|
Form of Lock-Up Agreement, dated as of August 23, 2023, by and between SEP Acquisition Corp. and the stockholder of SANUWAVE Health, Inc. party thereto (Incorporated by reference to Exhibit 10.3 to the Form 8-K
filed with the SEC on August 23, 2023).
|
|
List of subsidiaries
|
|
Consent of Marcum LLP, independent registered public accountants.
|
|
Power of Attorney (included on signature page).
|
|
Rule 13a-14(a)/15d-14(a) Certification of the Chief Executive Officer.
|
|
Rule 13a-14(a)/15d-14(a) Certification of the Chief Financial Officer.
|
|
Section 1350 Certification of the Chief Executive Officer.
|
|
Section 1350 Certification of the Chief Financial Officer.
|
|
101.INS
|
XBRL Instance
|
101.SCH
|
XBRL Taxonomy Extension Schema
|
101.CAL
|
XBRL Taxonomy Extension Calculation
|
101.DEF
|
XBRL Taxonomy Extension Definition
|
101.LAB
|
XBRL Taxonomy Extension Labels
|
101.PRE
|
XBRL Taxonomy Extension Presentation
|
104
|
Cover Page with Interactive Data File
|
|
SANUWAVE HEALTH, INC.
|
|
Dated: March 21, 2024
|
By:
|
/s/ Morgan Frank |
Name: Morgan Frank
|
||
Title: Chief Executive Officer
|
Signatures
|
Capacity
|
Date
|
||
By: /s/ Morgan Frank
Name: Morgan Frank
|
Chief Executive Officer and Chairman of the Board of Directors
(principal executive officer)
|
March 21, 2024
|
||
By: /s/ Toni Rinow
Name: Toni Rinow
|
Chief Financial Officer
(principal financial and accounting officer)
|
March 21, 2024
|
By: /s/ Kevin Richardson, II
Name: Kevin Richardson, II
|
Director
|
March 21, 2024
|
||
By: /s/ A. Michael Stolarski
Name: A. Michael Stolarski
|
Director
|
March 21, 2024
|
||
By: /s/ Jeff Blizard
Name: Jeff Blizard
|
Director
|
March 21, 2024
|
||
By: /s/ Ian Miller
Name: Ian Miller
|
Director
|
March 21, 2024
|
||
By: /s/ Jim Tyler
Name: Jim Tyler
|
Director
|
March 21, 2024
|