UNITED STATESSECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORTPursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 14, 2020

Soliton, Inc.(Exact name of registrant as specified in its charter)

Delaware 001-38815 36-4729076(State or other jurisdiction ofincorporation or organization)

(Commission File Number) (I.R.S. Employer Identification No.)

5304 Ashbrook DriveHouston, Texas 77081

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (844) 705-4866

Not Applicable(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions(see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 ofthe Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financialaccounting standards provided pursuant to Section 13(a) of the Exchange Act.

☐

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbols(s) Name of each exchange on which registered

Common stock, par value $0.001 per share SOLY The NASDAQ Stock Market

Item 2.02. Results of Operations and Financial Condition

On May 14, 2020, Soliton, Inc. (the "Company") issued a press release reporting its financial results for the first quarter ended March 31, 2020. A copy of the pressrelease is attached to this report as Exhibit 99.1 and is incorporated by reference herein.

Item 7.01. Regulation FD Disclosure

On May 14, 2020, the Company posted an updated corporate slide presentation on the investor relations page on its website, which may be viewed by investorsparticipating in the Company's earnings call and may be utilized for presentations. The slide presentation is attached hereto as Exhibit 99.2 and is incorporated by referenceherein.

The information contained in Items 2.02 and 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2, are being furnished and shall not be deemedto be “filed” for the purpose of the Securities Exchange Act of 1934, as amended (“Exchange Act”), nor shall they be deemed incorporated by reference in any filing under theExchange Act or the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated by reference.

Item 9.01. Financial Statements and Exhibits

(d) Exhibits

ExhibitNo. Exhibit

99.1 Soliton, Inc. Earnings Release dated May 14, 202099.2 Soliton, Inc. Corporate Slide Presentation May 2020

Signature

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto dulyauthorized.

SOLITON, INC.

By: /s/ Lori BissonLori BissonExecutive Vice-President,Chief Financial Officer

Dated: May 14, 2020

Soliton, Inc.5304 Ashbrook Drive

Houston, TX 77081

Soliton Reports First Quarter 2020 Results

Conference Call Today at 8:30am ET

May 14, 2020 – Houston, TX – Soliton, Inc., (Nasdaq: SOLY) (“Soliton” or the “Company”), a medical device company with a novel and proprietaryplatform technology, today reported financial results for the first quarter ended March 31, 2020.

Recent Company Highlights:

• Announced new strategic launch plan of next generation Rapid Acoustic Pulse (RAP) device expected to incorporate cellulite capability, if clearedby the FDA

• Received FDA clearance of Special 510(k) Premarket Notification for the Generation 2 RAP device• Granted key US patent, deepening broad IP portfolio for FDA cleared RAP technology with over 100 patents issued or pending.

First Quarter Company Milestones:

• Completed follow-up visits of all pivotal cellulite clinical trial patients; results to be presented at virtual American Academy of Dermatology 2020Conference in mid-June 2020

• Entered into a Manufacturing Services Agreement with leading integrated manufacturing solutions provider to manufacture RAP device andreplaceable cartridges

• Completed 12-week keloid and hypertrophic scar proof-of-concept clinical trial with positive results

Dr. Chris Capelli, Soliton’s President, CEO and co-founder, commented, “Although the first quarter of 2020 was largely governed by the unprecedentedCOVID-19 pandemic, Soliton continued to achieve a number of significant milestones, including FDA clearance of the Special 510(k) premarketnotification for the Generation II RAP device and the completion of both the 12-week keloid and hypertrophic scar proof-of-concept study and thepivotal cellulite clinical trial. We plan to present the results of the cellulite trial at the virtual AAD Conference expected to be held in mid-June 2020.The results of this study will support our anticipated 510(k) filing with the FDA for the treatment of cellulite during the second quarter. Our focusremains on executing our revised U.S. commercialization plans, adapted as a result of the COVID-19 crisis and now strategically incorporating bothtattoo removal and cellulite treatment into a Generation II RAP device. We remain optimistic the aesthetic and financial markets will recover and lookforward to providing details of our future U.S. commercial launch once conditions have stabilized for our dermatology customers.”

First Quarter 2020 Financial Results:

Operating expenses for the first quarter ended March 31, 2020 were $3.3 million, as compared to $2.4 million in the first quarter 2019. The increasewas primarily attributable to higher research and development expenses resulting from increases in spending with development partners and costsrelated to clinical trials.

Net loss for the first quarter ended March 31, 2020 was $3.3 million, or $0.19 basic and diluted net loss per share, compared with net loss of $3.4million, or $0.43 basic and diluted net loss per share, for the first quarter 2019.

Total cash was $7.7 million as of March 31, 2020, compared to $12.1 million as of December 31, 2019. The Company’s cash, cash equivalents andrestricted cash on hand is sufficient to fund the Company’s operations into December 2020 but not beyond.

Conference Call Details:

Management will host a conference call and live webcast to discuss Soliton’s financial results at 8:30 a.m. ET today. A question and answer session willfollow management remarks.

The dial-in numbers for the conference call are (833) 423-0479 for domestic callers and (918) 922-2373 for international callers. The conference ID is8193636.

A replay of the call will be available following its completion through May 21, 2020. To access the replay, dial (855) 859-2056 for domestic callers and(404) 537-3406 for international callers and use the replay conference ID 8193636.

A live audio webcast of the call will be available on the Investor Relations page of the Soliton, Inc. website, https://ir.soliton.com. A replay of thewebcast will be archived on Soliton’s website for 30 days following the completion of the call. ------------------------Join our more than 200K fans here to follow the Company: https://soly-investors.com------------------------

About Soliton, Inc.

Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from The University of Texas MD Anderson CancerCenter. The Company's first FDA cleared commercial product will use rapid pulses of acoustic shockwaves as an accessory to lasers for the removal ofunwanted tattoos. The Company is based in Houston, Texas, and is actively engaged in bringing the Rapid Acoustic Pulse ("RAP") device to the market.The Company believes this "Soliton" method has the potential to lower tattoo removal costs for patients, while increasing profitability to practitioners,compared to current laser removal methods. Soliton is investigating potential additional capabilities of the RAP technology in clinical and preclinicaltesting, including the potential to improve the appearance of cellulite by creating mechanical stress at the cellular level and inducing significantcollagen growth and the potential to treat keloid and hypertrophic scars by targeting the stiffened environment in the intracellular matrix.

For more information about the Company, please visit: http://www.soliton.com

Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E ofthe Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-lookingstatements in this press release include, without limitation, the ability to successfully complete the clinical trials planned for 2020 and to report datafrom such trials on a timely basis, to submit our FDA filing for the treatment of cellulite in the second quarter of 2020 and to receive FDA clearance forsuch indication, to effectively commercialize our products, and the ability of the RAP device to successfully treat cellulite and fibrotic scars. Thesestatements relate to future events, future expectations, plans and prospects. Although Soliton believes that the expectations reflected in suchforward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressedor implied by such forward-looking statements. Soliton has attempted to identify forward-looking statements by terminology including ''believes,''''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or otherwords that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions andinvolve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading"Item 1A. Risk Factors" in the Form 10-K for year ended December 31, 2019 we filed with the SEC on March 2, 2020 and updated from time to time inour Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date.Soliton undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring afterits date or to reflect the occurrence of unanticipated events.

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Rapid Acoustic Pulse Technology (Nasdaq: SOLY) FOR INTERNAL USE ONLY. Do not distribute without permission.

Legal Disclaimer All statements contained herein other than statements of historical fact, including statements regarding our future results of operations and financial position, our business strategy and plans, and our objectives for future operations, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events and trends discussed in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. More detailed information about Soliton is set forth in our filings with the Securities and Exchange Commission. Security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. 2

Overview Summary Breakthrough acoustic shockwave device using novel and proprietary Rapid Acoustic Pulse (RAP) technology § Induces mechanical disruption to targeted cellular level structures and vacuoles § No cavitation, heat or collateral tissue damage or pain Platform technology § Tattoo removal in as little as 1/3 the number office visits compared to standard of care § Cellulite reduction (Pivotal clinical results) § Keloids/other fibrotic disorders, accelerated fat reduction in clinical development > $10 billion in global market § Global market for tattoo removal is projected to be > $4 billion by 2023 § Global cellulite reduction market estimated to be ~ $4.0 billion by 2025 § Global keloid scar treatment market estimated to be ~ $10 billion by 2025 Images provided by Industrial Design firm; actual product may differ somewhat when the product is launched. There is no guarantee of a successful outcome of this revenue strategy. See disclosures at the end. 3

Management and Directors All life science veterans Multiple device clearances Multiple national and international aesthetic device launches 5

Science Advisory Board High profile Key Opinion Leaders Strong podium presence Respected, published researchers Also members of Allergan’s CoolSculpting Medical Advisory Board 6

Device and Revenue Strategy “razor and blade” recurring revenue model Sell or lease Hand piece contains Replaceable consumable consoles replaceable cartridge cartridge for one patient visit Images provided by Industrial Design firm; actual product may differ somewhat when the product is launched. There is no guarantee of a successful outcome of this revenue strategy. See disclosures at the end. 7

Electrode Cartridge § Electro-hydraulics (arc plasma in saline) utilizes 3000 volts at 3000 amps; creates shockwaves from .25 to 12 MPa @ 100 Hz § 8 patent § Electronic wave shaping enables very high families filed repetition rate; reduces unwanted frequencies that cause heat and pain § Worldwide exclusive license from § Custom designed reflector eliminates MD Anderson cavitation, heat, pain; non-focused, § 60601 Electrical Safety slightly diverging waves certified; 2 MOPP/MOOP § Different cartridges enable different § IRB “non-significant risk” therapies: tattoo removal and, if approved, established cellulite reduction and keloid scars. 8

Soliton’s Rapid Acoustic Pulse § Repetition rate and very short rise time provide microscopic mechanical disruption to targeted cellular level structures and vacuoles § High peak pressure and fast repetition rate exploit viscoelastic nature of tissue § Compressed pulses from electronic filtering and reflector shape eliminate cavitation, heat and pain Physical Effects § ECM/Fibrous Septa disruption (Acoustic subcision) § Non-cavitation/non-thermal physical effects Biological Effects (from Mechanotransduction) Hydrophone measurements using an Onda Corporation AIMS III (Acoustic § Collagenesis § Lymphangiogenesis Intensity Measurement System), using HNR-1000 Hydrophone; Z-Wave setup: § Angiogenesis § Inflammation inhibition Z-WavePro set to maximum output (185 mJ), using Z-Wave Handpiece 2.2 9

OPT A Acoustic ECM Disruption—Breakthrough Septa Disruption—Time Dose Response (Source: Control—Tx#26, Pig202 (68659); Test—Tx#63, Day O, Pig 210a. R1-R3 (68659 vs 91940 vs 91939 vs 91900); Head: Omega set at higher power 2800v, 100HZ, 70ms) CONTROL – 20X 1 MIN – 20X 2 MIN – 20X 3 MIN – 20X 10

Potential Fibrosis Treatment: Long-Term Importance What causes Fibrosis? Stiff Extracellular Fibrotic Fibroblast Matrix (“ECM”) Fibroblast Fibrosis RAP Treatment for Fibrosis Multiple Aesthetic Indications RAP Fibrotic Preventative Stiff Non-Stiff or Tissue Fibroblast ECM ECM Therapeutic Disruption Apoptosis Treatment Significant Medical Indications 11

Soliton’s Pipeline FDA Commercial GLOBAL MARKET Indication Pre-Clinical Human POC Pivotal Clearance Launch OPPORTUNITY Tattoo Removal $4.0B Cellulite Reduction $4.0B Keloid and Hypertrophic Scar Reduction $10.0B Skin Laxity Reduction $6.3B 13

Targeted Indications Pathway Cleared In Clinic Future Tattoo Removal Tattoo Removal Cellulite Skin Rejuvenation: Abdomen Cellulite: Skin Rejuvenation Skin Rejuvenation: General Skin Rejuv.: Knees/Elbows Fibrotic Scars Post-Surgical Keloid: Radiation Induced Fibrotic Scars Radiation Induced (Preventative) Burn Induced Capsular Contracture Reduction Breast Implants: Capsular Contracture Prevention Capsular Contraction 14

Tattoo Removal: First Indication

63%* are considering tattoo removal 44 million Americans 70 23% are want some form of MILLION “regretters”** tattoo removal 44 So, why isn’t this already MILLION a billion dollar business? US prospects 29% have at 240 least one tattoo MILLION *As demonstrated in our own proprietary market research conducted by iResearch in Total US Population conjunction with The Phillips Agency. ** The Harris Poll of 2,225 U.S. adults surveyed online from October 14-19, 2015. See disclosures at the beginning. 16

Laser Removal (current standard of care) presents huge barriers Complete tattoo removal means repeating visits >10 times over 1 - 2 years* Timeline reduction changes industry approach *December 2012 Archives of Dermatology There is no guarantee of any outcome. Patients' individual experiences may vary. 17

Statistically Significant Clinical Results § Soliton RAP delivered 75% or greater fading in 100% of patients* after 3 office visits § Outperformed “laser-only” 100%* of the time *Results presented from the Company’s 2017 clinical trial. Fading percentages were determined by a panel of unaffiliated doctors who reviewed the patient results and graded fading. There is no guarantee of any successful outcome for any clinical trial. 18

Complete removal of Before treated ink after 3 treatments After 3 Treatments Individual results will vary. For illustrative purposes only. 19

Cellulite Treatment: Second Potential Indication FOR INTERNAL USE ONLY. Do not distribute without permission.

95 54 million US MILLION Total US women want to Women Population improve their cellulite (Age 15-54) $4B market by 2025.* 81 80-90% suffer MILLION 5% market share = from cellulite $200M revenue. 67%** want to do something 54 about it MILLION US prospects *Is indicated in Medical News Today November 30, 2017. ** Per Cellfina.co.us/hcp-lets-talk-about-cellulite/ See disclosures at the beginning. 21

Competitive Landscape in Cellulite Long-term Side Patient Company Technology Noninvasive Avg Cost # Trmts Duration Effects Satisfaction Syneron Candela RF $1,600 4+ L 60% Cynosure RF & massage 6 L Solta RF $2,475 1 H 67% BTL RF & targeted pressure energy $3,100 4 L 90% Venus Concept RF & pulsed EM fields $2,050 6+ L 62% NOT Allergan Cryotherapy $2,425 1 M EFFECTIVE ON CELLULITE Soliton Rapid Acoustic Pulse $2,500 1 L 92% Merz Surgical Procedure $4,250 1 H 94% Cynosure Laser used under skin $5,775 1 H 92.5% $3,500 Endo Injected Drug 3 H 62.9% per vial

The Soliton Approach to Cellulite Acoustic Subcision Cellulite Dimples Epidermis Dermis Fat Cells Fibrous Septa Septa contracts and becomes sclerotic holding Our device emits rapid acoustic shock wave portions of the skin with a non-flexible length of septa pulses that are transmitted through the skin This results in areas of the skin being pulled down to break apart or “shear” the fibrotic septa while adjacent sections bulge outward resulting in dimples and ridges Soliton has not yet received FDA pre-market clearance for the cellulite indication 23

Results: POC POC RAP Cellulite Trial Single-Treatment 26-Week CSS Scores IPR Average Assessment (n=3) Efficacy 5.00 § 100% correct selection of the before and 5.0 4.83 12-week post-treatment photos by all 4.67 P < 0.001 blinded reviewers 4.27 4.00 4.00 § At 26 weeks, average reduction of the 4.0 Cellulite Severity Scale (CSS) to 2.93 from 4.27 (p<0.001) 3.17 2.93 3.0 2.83 2.83 Participant Perception of Improvement and 2.33 2.33 Satisfaction CSS Score 2.0 § 4 of 5 self-reported improvement § 80% indicated “improved” to “very much improved” 1.0 Pain § 97% of treatments were rated 0 on a 0 to 0.0 Pt001 Pt002 Pt003 Pt004 Pt005 Average Total 10-point pain scale (with 0 being no pain) Pre-Tx 26-weeks Post-Tx 24

POC Trial Patient after Single RAP Treatment Before 12-WK 26-WK

Keloid and Hypertrophic Scar Treatment: Third Potential Indication (and Support for Other Fibrotic Disease Targets) FOR INTERNAL USE ONLY. Do not distribute without permission.

Fibrotic Scar POC Trial Results Change in Keloid Volume Average Scar Volume Change at 6 and 12 weeks RAP V. Cryo+TAC Post Single 6 minute RAP Treatment 40 200 35 190.9 180 30 25 % Vol Change - RAP 160 20 % Vol Change - 4x Cryo+TAC VOLUME 29.6% RAP Treatment 140 15 Cryo+TAC Treatments 138.4 % Decrease in Volume 134.4 10 120 5 0 100 0 6 12 0 4 8 12 16 WEEKS NOTE: Head to head trial not conducted. Clinical results shown versus separate, independent study. Treatment Safety Toleration 10 patients (11 keloids); No unexpected adverse events; mild All patients (100%) stated RAP treatment was tolerable; average single 6-minute RAP treatment erythema; occasional pinpoint bleeding overall pain score during procedure: 2.2 on a 0-10 pain scale 27

COVID-19 IMPACT Significant economic impact on the aesthetic marketplace with majority of cosmetic dermatologists shuttering their practice during stay-at-home orders Revised commercial launch timeline appropriate in this environment; plan modified to incorporate cellulite technology into initial launch, if cleared by FDA, and advance cost down design of cartridges Impact on financial markets influencing Company’s financing strategy and driving decisions to defer commercialization spending and increase cash runway There is no guarantee of any successful outcome for any clinical trial. Projected numbers are estimates, are subject to change without notice and there is no guarantee such projections will be met. See disclosures at the end. 28

Post Covid-19 Tentative Commercialization Pathway 2020 2021 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 3Q21 4Q21 COVID-!9 IMPACT Brand Development FDA – Device Upgrades Staffing Additions COVID-!9 IMPACT Commercial Launch Sales Force Build Cellulite FDA Clearance This schedule portrays a possible path to commercialization. The remaining impact of COVID-19 on the aesthetic and financial markets continue to create uncertainty around the timing of launch for the Company. 29

Key Milestones MILESTONE ANTICIPATED TIMING FDA Clearance for Tattoo Removal May 2019 Cellulite POC study– 26-week time point May 2019 Cellulite POC 26-week Data Release in Las Vegas Aesthetics Show July 2019 Initiate Cellulite Pivotal Trial Mid 2019 Keloid Scarring POC Trial Mid 2019 FDA Clearance for Gen II RAP Device upgrades Q1 2020 Announce Pivotal Cellulite Results Q2 2020 File FDA Application for Cellulite Q2 2020 Cellulite FDA clearance Q420-Q121 Commercial Launch for Tattoo Impacted by COVID-19 2H 2020, if not impacted POC Study – Fourth indication by COVID-19 Keloid POC2 – DOSING to be initiated 2H 2020, if not impacted by COVID-19 30

Thank you Rapid Acoustic Pulse Technology (Nasdaq: SOLY) FOR INTERNAL USE ONLY. Do not distribute without permission.