Monthly Archives: March 2020

Sanara MedTech Inc. Announces 2019 Results

FORT WORTH, TX / ACCESSWIRE / March 26, 2020 / Sanara MedTech Inc. Based in Fort Worth, Texas, Sanara MedTech Inc. ("Sanara" or the "Company") (OTCQB:SMTI), a provider of surgical and chronic wound care products dedicated to improving patient outcomes, announced today its strategic, operational and financial results for the quarter and full-year ended December 31, 2019.

Ron Nixon, Sanara's Executive Chairman stated, "Sanara's fourth-quarter 2019 and full-year results reflect the continued execution of our strategic growth plan. During both Q4 2019 and the full year we saw record sales and a significant upward trend in our revenue as we continue our expansion plans in both the surgical wound and chronic wound care markets. We expect the investments in people, distribution, training, and new products to significantly benefit the Company's growth and national market penetration."

Strategic Highlights and Fourth Quarter 2019 Milestones

Since the beginning of 2020, the COVID-19 virus has emerged as a threat to the global economy including Sanara Medtech. Beginning in the second half of March, the virus and the associated slowdown in surgical procedures started to have an impact on the Company's business. With a significant percentage of Sanara's revenue coming from elective surgeries that have been or will be postponed, management is expecting a further decline in revenue until such time that the elective surgery market returns to full capacity. To counter this, the Company is proactively taking significant steps to cut costs, manage cash-flow, and continue to generate revenue from both its wound care and surgical businesses until this situation has improved. The duration and severity of the impact from the COVID-19 virus is unclear, but management believes that surgical procedures currently being delayed that would utilize the company's products will ultimately be performed.

After the end of the quarter, The Catalyst Group, Inc., through its affiliates (collectively, "Catalyst"), converted its entire holdings of Sanara MedTech Inc.'s 30-month $1,500,000 convertible promissory note and Series F Convertible Preferred Stock into shares of Sanara Common Stock. The Company issued an aggregate of 2,452,731 shares of Common Stock in the conversions. After the conversions, Catalyst controls the voting of a total of 3,416,587 shares of Common Stock, which represents 56.7% of the 6,023,732 shares of Common Stock currently outstanding.

On October 15, 2019, the Company closed a private placement offering of 1,204,820 newly issued shares of its common stock in a $10 million private placement offering. The purchasers in the offering consisted of related party entities to three members of the Company's Board of Directors. The transaction was approved by all of the disinterested Directors of the Company. $2.2 million of the proceeds were used to retire indebtedness under the Company's bank line of credit. The balance of the proceeds are being used to fund milestone payments under current and future product license agreements as well as operating expenditures, including clinical studies and continued expansion of the Company's sales force.

On October 1, 2019, Sanara executed a second license agreement with Rochal Industries, LLC ("Rochal") whereby Sanara acquired an exclusive world-wide license to market, sell and further develop certain antimicrobial barrier film and skin protectant products for use in the human health care market utilizing Rochal patents and pending patent applications. Products covered by the license agreement are CuraShield™ Antimicrobial Barrier Film (CuraShield™ ABF) and CuraShield™ No Sting Skin Protectant.

Commentary on Future Products – Two New Impactful Products Planned to Launch in 2020

The Company received FDA clearance for BIAKŌS™ Antimicrobial Wound Gel in February 2020 and expects to launch the product this year to complement its BIAKŌS™ Antimicrobial Wound Cleanser. Both products are effective against planktonic microbes as well as immature and mature biofilms. When used together, the cleanser can be used initially to clean a wound and disrupt biofilms (removing 99% in 10 minutes). The gel can then be applied and will remain in the wound for up to 72 hours, eliminating biofilms between normal dressing changes.

The Company also expects to introduce CuraShield™ ABF in the latter part of 2020. CuraShield™ ABF is an FDA cleared, first in-class, antimicrobial spray-on wound dressing that kills microbes while protecting underlying tissue, helping to remediate damage and prevent further infection.

Full-Year 2019 Consolidated Financial Results – Sanara MedTech Inc. Continued Growth and Execution of Strategic Plan

Revenues. For the year ended December 31, 2019, the Company generated revenues of $11,766,763 compared to revenues of $8,779,872 for the year ended December 31, 2018, or a 34% increase from the prior year. For the quarter ending December 31, 2019, the Company generated revenues of $3,353,096 compared to revenues of $2,909,282 for the quarter ending September 30, 2019. The higher revenues in 2019 were primarily due to the continued execution of the Company's strategy to expand its sales force and independent distribution network in both new and existing U.S. markets.

Selling, general and administrative expenses ("SG&A"). SG&A expenses for the year ended December 31, 2019, were $ 13,067,569 compared to SG&A expenses of $ 7,646,119 for the year ended December 31, 2018. SG&A expenses for the quarter ending December 31, 2019 were $ 4,418,383 compared to SG&A expenses of $3,315,757 for the quarter ending September 30, 2019. The higher SG&A expenses in 2019 were primarily due to increased payroll costs resulting from sales force expansion and operational support, along with higher sales commission expense as a result of higher product sales, and increased marketing costs related to promotional activities for new and existing product lines. Direct selling costs represented the vast majority of the increase in total SG&A costs as we more than doubled the size of our field sales organization from eight to eighteen in 2019.

The higher SG&A costs are consistent with the Company's strategy of building out a larger sales force and independent distribution network. New sales representatives on average take six to twelve months to begin generating significant revenue. The Company expects SG&A expenses as a percentage of revenue to decline in the next two years as the expected revenue generated by its new sales force begins to offset the cost of expanding the sales force.
 
Net income / loss. For the year ended December 31, 2019, the Company had a net loss of $2,814,088, compared to net income of $175,464 for the year ended December 31, 2018. For the quarter ending December 31, 2019, the Company had a net loss of $1,455,812 compared to a net loss of $843,233 for the quarter ending September 30, 2019.The net loss in 2019 was due to higher SG&A costs described above, which have been driven by the Company's strategy to grow top-line revenue through significant investments in sales force expansion and related sales support infrastructure as well as other areas of administrative support. Because of required acquisition accounting rules, the financial statements for the year ended December 31, 2019 do not include revenues and expenses for the period January 1, 2019 through March 15, 2019 in which revenues were approximately $34,000 and expenses were approximately $348,000.

About Sanara MedTech Inc.

With a focus on improving patient outcomes through evidence-based healing solutions, Sanara MedTech Inc. markets and distributes wound and skincare products to physicians, hospitals, clinics, and all post-acute care settings. We are constantly seeking long-term strategic partnerships with a focus on products that produce efficacious outcomes at a lower overall cost. Our products are primarily sold in the North American advanced wound care and surgical tissue repair markets. Sanara MedTech markets and distributes CellerateRX® Surgical Activated Collagen® to the surgical markets as well as the following products to the wound care market: BIAKŌS™ Antimicrobial Skin and Wound Cleanser, HYCOL™ Hydrolyzed Collagen, and PULSAR II™ Advanced Wound Irrigation™ (AWI). In addition, Sanara is actively seeking to expand within its six focus areas of wound and skincare for the acute, post-acute, and surgical markets. The focus areas are debridement, biofilm removal, hydrolyzed collagen, advanced biologics, negative pressure wound therapy adjunct products, and the oxygen delivery system segment of the healthcare industry. For more information, visit SanaraMedTech.com.

Information about Forward-Looking Statements

The statements in the press release that relate to the Company's expectations with regard to the future impact on the Company's results from new products in development and any other statements not constituting historical facts are "forward-looking statements," within the meaning of and subject to the safe harbor created by the Private Securities Litigation Reform Act of 1995. Since this information may contain statements that involve risk and uncertainties and are subject to change at any time, the Company's actual results may differ materially from expected results. This document may contain forward-looking statements concerning the Company's operations, current and future performance and financial condition. These items involve risks, contingencies and uncertainties such as product demand, market and customer acceptance, the effect of economic conditions, competition, pricing, the ability to consummate and integrate acquisitions, and other risks, contingencies and uncertainties detailed in the Company's SEC filings, which could cause the Company's actual operating results, performance or business plans or prospects to differ materially from those expressed in, or implied by these statements. The Company undertakes no obligation to revise any of these statements to reflect the future circumstances or the occurrence of unanticipated events.

Investor Contact:

Callon Nichols, Director of Investor Relations
713-826-0524
CNichols@sanaramedtech.com

SOURCE: Sanara MedTech Inc.

ReleaseID: 582771

HAGENS BERMAN, NATIONAL TRIAL ATTORNEYS, Alerts Sasol Limited (SSL) Investors: Application Deadline 11 Days Away, Investors with Losses Should Contact its Attorneys

SAN FRANCISCO, CA / ACCESSWIRE / March 26, 2020 / Hagens Berman urges investors in Sasol ADRs (NYSE:SSL) who have suffered significant losses to submit their losses now. The April 6, 2020 lead plaintiff deadline in a securities fraud class action that has been filed against the company and senior executives is fast approaching.

Class Period: Mar. 10, 2015 – Jan. 13, 2020

Lead Plaintiff Deadline: Apr. 6, 2020

Sign Up: www.hbsslaw.com/investor-fraud/SSL

Contact An Attorney Now: SSL@hbsslaw.com

844-916-0895

Sasol Limited (SSL) Securities Class Action:

According to the Complaint, Defendants misled investors by misrepresenting and failing to disclose that; (1) Sasol conducted insufficient due diligence into, and did not account for multiple issues with, Sasol's Lake Charles chemical plant ("LCCP"), as well as its true cost; (2) construction and operation of the LCCP was plagued by control weaknesses, delays, rising costs, and technical issues; and (3) Sasol's top-level management exacerbated these issues by engaging in improper and unethical behavior concerning financial reporting for, and oversight of, the LCCP.

Investors began to learn the truth through a series of disclosures, including on May 22, 2019, when Sasol abruptly raised the project's cost estimate by $1 billion and disclosed an internal review into the project's costs and construction schedule. The company admitted to weaknesses in the project's integrated controls, as well as significant additional concerns related to the project's forecasting process.

Then, on Oct. 27, 2019, Sasol terminated its co-CEOs following an internal probe showing that the Lake Charles project management team acted inappropriately, lacked experience, and was overly focused on maintaining cost and schedule estimates instead of providing accurate information.

Finally, on Jan. 13, 2020, Sasol disclosed an explosion and fire at its Lake Charles project's low-density polyethylene unit, requiring the company to shut down the unit.

Each of these disclosures caused the price of Sasol ADRs to decline sharply.

"We're focused on investors' losses and proving Sasol misled investors about the Lake Charles project's cost, timing and internal controls," said Reed Kathrein, the Hagens Berman partner leading the investigation.

If you purchased Sasol ADRs and suffered significant losses, click here to discuss your legal rights with Hagens Berman.

Whistleblowers: Persons with non-public information regarding Sasol should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email SSL@hbsslaw.com.

# # #

About Hagens Berman
Hagens Berman is a national law firm with nine offices in eight cities around the country and eighty attorneys. The firm represents investors, whistleblowers, workers and consumers in complex litigation. More about the firm and its successes is located at hbsslaw.com. For the latest news visit our newsroom or follow us on Twitter at @classactionlaw.

CONTACT: 
Reed Kathrein
844-916-0895

SOURCE: Hagens Berman Sobol Shapiro LLP

ReleaseID: 582772

GOSS Shareholder Alert: Bronstein, Gewirtz & Grossman, LLC Notifies Shareholders of Investigation of Gossamer Bio, Inc. and Encourages Investors to Contact the Firm

NEW YORK, NY / ACCESSWIRE / March 26, 2020 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Gossamer Bio, Inc. ("Gossamer " or "the Company") (NASDAQ:GOSS). Investors who purchased Gossamer securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: www.bgandg.com/goss.

The investigation concerns whether Gossamer and certain of its officers and/or directors have violated federal securities laws.

Gossamer's most advanced product is its GB001 drug, a DP2 antagonist, in development to treat asthma. In February 2019, Gossamer conducted its initial public offering ("IPO"), issuing approximately 19.8 million shares of common stock priced at $19.00 per share. Then, on December 16, 2019, Novartis announced that it was terminating the development of its DP2 antagonist for asthma after it failed a pair of phase 3 clinical trials. Following this announcement, Gossamer's stock price fell $9.41 per share, or 37.09%, to close at $15.96 per share on December 16, 2019.

If you are aware of any facts relating to this investigation, or purchased Gossamer shares, you can assist this investigation by visiting the firm's site: www.bgandg.com/goss. You can also contact Peretz Bronstein or his Investor Relations Analyst, Yael Hurwitz of Bronstein, Gewirtz & Grossman, LLC: 212-697-6484.

Bronstein, Gewirtz & Grossman, LLC is a corporate litigation boutique. Our primary expertise is the aggressive pursuit of litigation claims on behalf of our clients. In addition to representing institutions and other investor plaintiffs in class action security litigation, the firm's expertise includes general corporate and commercial litigation, as well as securities arbitration. Attorney advertising. Prior results do not guarantee similar outcomes.

CONTACT:

Bronstein, Gewirtz & Grossman, LLC
Peretz Bronstein or Yael Hurwitz
212-697-6484 | info@bgandg.com

SOURCE: Bronstein, Gewirtz and Grossman, LLC

ReleaseID: 582770

Vitro Biopharma First Quarter ended January 31, 2020 Financial Results of Operations

GOLDEN, CO / ACCESSWIRE / March 26, 2020 / Vitro Diagnostics, Inc. (OTCPINK:VODG), dba Vitro Biopharma, announced its 1st quarter ended January 31st, 2020 financial results of operations.

Vitro Diagnostics Inc. ("Vitro Biopharma") is pleased to announce a record 1st comparative quarter in Total Revenues. Vitro Biopharma recorded 1st quarter revenues of $225,921 vs $192,895 an increase of 17% over the same comparative quarter last year. In addition, Stem Cell treatments accounted for 74% of the revenues up from 71% of the revenues in the prior comparative quarter last year. Current quarter stem cell revenues were $167,750 for the 1st quarter ended January 31, 2020 vs $137,123 for the first quarter ended January 31, 2019.

The company's gross profit margins improved to 75% up from 73% in the comparative prior year's quarter. Gross margin improvement is in line with the strategic direction of the company to expand the market of its flagship product AlloRx™ Stem Cells. The company's clean-room lab expansion last year and expanded Stem Cell manufacturing using its patent-pending cell line, has increased efficiencies and lowered production costs.

Overall operating expenses increased in the quarter to $193,385 from $147,398 in the prior year's comparative quarter. The increase in expenses reflects additional investment as the Company expands its capability to service its strategic direction of offshore Stem Cell treatments while also expanding into US markets. The company expended additional resources on external consultants supporting our regulatory status in maintaining ISO9001 & ISO13485 certifications, expanding our efforts to approach US markets through FDA filings and advancement of existing patent filings.

The company's first quarter is its most seasonal quarter as the period between Thanksgiving and the New Year is slow for all the company's revenue lines of Nutra Vivo™/STEMulize, AlloRx™ Stem Cells, private labeled InfiniVive-MD™ Stem Cell Serum and our core research products.

During the quarter the company achieved and pursed the following company objectives

Series A Convertible Preferred Stock Offering:

During the quarter the company commenced a Series A Convertible Preferred Stock offering to accredited investors under the SEC Regulation D exemption. The preferred Stock is priced at $25 per share which is convertible at $0.25 cents per share for a total of 100 shares. The minimum investment is $50,000 per unit. The company sold $450,000 of the Series A Convertible Preferred Stock during the quarter. The company has additional interest in the offering and subsequent to the quarter has sold an additional $50,000 unit for a total to date of $500,000. The company has additional interested parties for approximately $200,000. The offering is for a total of $1,000,000.

Expansion of revenues & results from the clinical trials in the Cayman Islands:

Our partnership with DVC. Stem in the Cayman Islands continued to advance through treatment of new & previous patients. This IRB-approved protocol targets patients with inflammatory conditions including multiple sclerosis, systemic inflammation and new indications including Chrohn's disease, Alzheimer's disease and COPD. To date we have treated 60 patients including repeat treatments. There have been no serious adverse events and we continue to gain evidence of efficacy. One of the initial MS patients has now received a second transplant of our AlloRx™ Stem Cells and he has reported significant therapeutic benefits of both the initial and subsequent therapy. He had received an earlier transplant of adipose-derived MSCs that was effective, but the improvement lasted 3 months while AlloRx™ Stem Cell therapy lasted 18 months. We had predicted such a clinical outcome based on significantly higher potency of umbilical cord MSCS compared to those derived from adipose tissue or bone marrow. The Chrohn's disease patient showed significant improvement as did both the AD & COPD patients.

Further Expansion into US Markets-FDA IND:

The strategic development of our stem cell therapies involves pursuit of both offshore and domestic markets. The partnership with DVC Stem, our IRB-approved trial in the Bahamas together with other strategic opportunities represent offshore operations & prospects. During Q1 2020, we initiated expansion into US therapeutic markets through development of an Investigational New Drug (IND) application for submission to FDA. Once approved, an IND allows the conduct of clinical trials for specific medical conditions in the US.

Given the current COVID-19 pandemic, our initial IND application is for use of AlloRx™ Stem Cells in treatment of Coronavirus infections. This is supported by clinical studies showing that 17 critically ill patients responded favorably to IV infusion of umbilical cord-derived MSCs. All patients were receiving assisted ventilation but 3 days following stem cell therapy, were removed from ventilators and subsequently discharged from the hospital. We are pursuing discussions with FDA to establish the appropriate regulatory pathway and expedited review options given the current emergency circumstances. (See Subsequent Events, below, for additional discussion of our COVID-19 response.) Once our initial IND is in place, we have plans for additional INDs for stem cell therapy of musculoskeletal conditions and Alzheimer's disease.

PR Medica Opportunity

We have received an initial order of AlloRx™ Stem Cells for testing purposes by PR Medica located in Cabo San Lucas. Given successful test results, we anticipate subsequent new revenue generation from this customer.

InfiniVive-MD™ Stem Cell Serum:

Vitro Biopharma's cosmetic topical stem cell serum is being distributed by InfiniVive MD™ into cosmetic clinics that are providing the topical treatment as a beautification product. To date the company's product is being offered in 10 cosmetic clinics.

Our partner, Dr Jack Zamora, MD was a keynote speaker at a master session at the American Academy of Cosmetic Surgery annual meeting in late February. The topic of his presentation was "Topical Stem Cells, Exosomes and Conditioned Media Serums in Aesthetics." This was the official launch of the InfiniVive-MD platform including: Dailey Serum, Stem Cell Serum 2.0 & Exosomes within the product line. Vitro Biopharma will manufacture & private label these new products for distribution in the US. We anticipate InfiniVive MD growth, development and revenues to mirror the development of Apyx subdermal plasma skin tightening as a cosmetic treatment and technique that has gone global.

www.jackzamoramd.com www.infinivivemd.com

Research and Development, Facility Expansion & Patent Prosecution

Our core research product sales continued to expand in Q1 2020. Our facility expansion continued with addition of manufacturing capacity and development of plans to add operational facility to increase outputs further by 100% or more. We were also in discussions with the USPTO regarding our pending patents for our novel stem cell therapy and stem cell activation technology. We continue to work closely with our examiner and have established communication channels to facilitate awards of these patents.

SUBSEQUENT EVENTS: COVID-19 Opportunity and Risks

The COVD-19 pandemic is a significant obstacle for all business. However, Vitro Biopharma is uniquely positioned since we have a potential effective therapy. This is based on 3 independent reports showing efficacy of stem cell therapy in 17 COVID-19 patients. All were treated with IV umbilical cord MSCs comparable to AlloRx™ Stem Cells and all 17 required respiratory assistance but within 3-4 days of treatment, were able to breath without ventilators and were discharged within 14 days. https://www.scmp.com/news/china/society/article/3053080/coronavirus-critically-ill-chinese-patient-saved-stem-cell On the contrary, untreated patients on ventilators have death rates of 50% or more. We have received a formal request to supply AlloRx™ Stem Cells for compassionate use from a major university medical center and several other potential clinical partners have also expressed interest in using our cells to treat COVID-19 patients. We are presently working with the FDA to gain authority to begin clinical testing in the US. We are currently assessing the overall financial impact of the COVID-19 pandemic on our business, but this depends on overall control of the pandemic. There have been no staff layoffs and our workers are considered essential since we conduct essential research to the COVID-19 response.

Dr. Jim Musick, CEO of Vitro Biopharma, said, "We are very pleased with the increased revenue growth during our first quarter 2020 compared to the prior year However all our resources are currently focused on the emergency response to the COVID-19 pandemic and increasing our inventory of AlloRx to satisfy anticipated emergency demand to treat critically ill COVID-19 patients." The Company is working to get expedited clinical trial approvals to sell our AlloRx Stem Cells to hospitals coping with the pandemic. Vitro is pleased to have recently been recognized by Bioinformant as "a Company Tracking the Coronavirus". https://bioinformant.com/product/coronavirus-covid-19-report/ We anticipate clinical progress in the effectiveness of our stem cell therapies while expecting to see a reduction in our offshore and cosmetic revenues for the next quarter or two. The company is in a good cash position to weather this storm and simultaneously advance its AlloRx stem cell therapies into clinical trials.

In summary, Vitro Biopharma is advancing as a key player in regenerative medicine with 10- years' experience in the development and commercialization of stem cell products for research, recognized by a Best in Practice Technology Innovation Leadership award for Stem Cell Tools and Technology and a growing track record of successful translation to therapy. We are leveraging our proprietary technology platform to the establishment of international Stem Cell Centers of Excellence and regulatory approvals in the US and worldwide.

Sincerely yours,

James R. Musick, PhD.
President, CEO & Chairman of the Board
www.vitrobiopharma.com

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company's auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements". Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:

Dr. James Musick
Chief Executive Officer
Vitro BioPharma
(303) 999-2130 Ext. 3
E-mail: jim@vitrobiopharma.com
www.vitrobiopharma.com

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

SOURCE: Vitro Diagnostics, Inc.

ReleaseID: 582759

CLASS ACTION UPDATE for HPQ, MGPI and INO: Levi & Korsinsky, LLP Reminds Investors of Class Actions on Behalf of Shareholders

NEW YORK, NY / ACCESSWIRE / March 26, 2020 / Levi & Korsinsky, LLP announces that class action lawsuits have commenced on behalf of shareholders of the following publicly-traded companies. Shareholders interested in serving as lead plaintiff have until the deadlines listed to petition the court. Further details about the cases can be found at the links provided. There is no cost or obligation to you.

HPQ Shareholders Click Here: https://www.zlk.com/pslra-1/hp-inc-loss-form?prid=5823&wire=1
MGPI Shareholders Click Here: https://www.zlk.com/pslra-1/mgp-ingredients-inc-loss-form?prid=5823&wire=1
INO Shareholders Click Here: https://www.zlk.com/pslra-1/inovio-pharmaceuticals-inc-loss-form?prid=5823&wire=1

* ADDITIONAL INFORMATION BELOW *

HP Inc. (NYSE:HPQ)

HPQ Lawsuit on behalf of: investors who purchased February 23, 2017 – October 3, 2019
Lead Plaintiff Deadline: April 20, 2020
TO LEARN MORE, VISIT: https://www.zlk.com/pslra-1/hp-inc-loss-form?prid=5823&wire=1

According to the filed complaint, defendants knew that HP's "four-box" model for measuring its supplies business was severely deficient and not a strong predictor of supplies demand and outcomes because HP lacked telemetry data from its commercial printers and had to use unreliable and stagnant market share data to develop assumptions for the four-box model. The complaint further alleges that defendants knew the lack of telemetry data for commercial printing was a critical shortcoming of the four-box model because HP possessed telemetry data on its personal printing side and knew it was a necessary element for an accurate understanding of the supplies channel. As a result, the supplies inventory in the Company's channel exceeded demand by at least $100 million and HP's supplies revenue growth was grossly inflated.

MGP Ingredients, Inc. (NASDAQ:MGPI)

MGPI Lawsuit on behalf of: investors who purchased February 27, 2019 – February 25, 2020
Lead Plaintiff Deadline: April 28, 2020
TO LEARN MORE, VISIT: https://www.zlk.com/pslra-1/mgp-ingredients-inc-loss-form?prid=5823&wire=1

According to the filed complaint, during the class period, MGP Ingredients, Inc. made materially false and/or misleading statements and/or failed to disclose that: (a) MGP had not completed any significant sales of its four-year-old aged whiskey inventory; (b) the Company had been unable to sell its aged whiskey at the price premium represented to investors; (c) a glut of aged whiskey inventory and shifts in consumer behavior had lowered the value of the Company's aged whiskey inventory and materially impaired its ability to negotiate significant sales on favorable contract terms; and (d) in light of the foregoing, the Company's FY19 financial forecast lacked a reasonable basis and was materially misleading.

Inovio Pharmaceuticals, Inc. (NASDAQ:INO)

INO Lawsuit on behalf of: investors who purchased February 14, 2020 – March 9, 2020
Lead Plaintiff Deadline: May 12, 2020
TO LEARN MORE, VISIT: https://www.zlk.com/pslra-1/inovio-pharmaceuticals-inc-loss-form?prid=5823&wire=1

According to a filed complaint, throughout the class period, defendants made misleading statements about the company's development of a purported vaccine for the novel coronavirus, artificially inflating the company's share price and resulting in significant investor losses.

You have until the lead plaintiff deadlines to request that the court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff.

Levi & Korsinsky is a nationally recognized firm with offices in New York, California, Connecticut, and Washington D.C. The firm's attorneys have extensive expertise and experience representing investors in securities litigation and have recovered hundreds of millions of dollars for aggrieved shareholders. Attorney advertising. Prior results do not guarantee similar outcomes.

CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
55 Broadway, 10th Floor
New York, NY 10006
jlevi@levikorsinsky.com
Tel: (212) 363-7500
Fax: (212) 363-7171
www.zlk.com

SOURCE: Levi & Korsinsky, LLP

ReleaseID: 582765

Sky Gold Amends Financing

VANCOUVER, BC / ACCESSWIRE / March 26, 2020 / Sky Gold Corp. (TSXV:SKYG) (OTCPINK:SRKZF)("Sky Gold Cop." or the "Company") announces that it has amended its previously announced non-brokered private placement (see PR dated January 31, 2020) to now be up to 5 million units at $0.05 for aggregate gross proceeds of $250,000.

Each Unit will be comprised of one common share ("Share") and one whole transferable common share purchase warrant of the Company ("Warrant"). Each whole Warrant will entitle the Subscriber to purchase one common Share for a 24-month period after the Closing Date at an exercise price of $0.10 per share.

Proceeds raised from the Offering will be used for general working capital and to potentially expand on recently acquired land tenures in Central Newfoundland.

Finders' fees may be payable on the private placement, subject to the policies of the TSX Venture Exchange.

About Sky Gold Corp.

Sky Gold Corp. is a junior mineral exploration company engaged in acquiring and advancing mineral properties in Canada and the USA.

ON BEHALF OF THE BOARD

"Mike England"

Mike England,
CEO&DIRECTOR

FOR FURTHER INFORMATION PLEASE CONTACT:

Telephone: 1-604-683-3995
Toll Free: 1-888-945-770

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

SOURCE: Sky Gold Corp.

ReleaseID: 582764

INVESTOR ALERT: Kessler Topaz Meltzer & Check, LLP Reminds Investors of Securities Fraud Class Action Lawsuit Filed Against INOVIO PHARMACEUTICALS, INC.

RADNOR, PA / ACCESSWIRE / March 26, 2020 / The law firm of Kessler Topaz Meltzer & Check, LLP reminds investors that a securities fraud class action lawsuit has been filed in the United States District Court for the Eastern District of Pennsylvania against Inovio Pharmaceuticals, Inc. (NASDAQ:INO) ("Inovio") on behalf of those who purchased or otherwise acquired Inovio common stock between February 14, 2020 and March 9, 2020, inclusive (the "Class Period").

Important Deadline: Investors who purchased or otherwise acquired Inovio common stock during the Class Period may, no later than May 12, 2020, seek to be appointed as a lead plaintiff representative of the class. For additional information or to learn how to participate in this litigation please click https://www.ktmc.com/inovio-pharmaceuticals-securities-class-action?utm_source=PR&utm_medium=link&utm_campaign=inovio.

According to the complaint, Inovio is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat, cure and/or protect people from infectious diseases. The worldwide outbreak of the novel coronavirus, COVID-19, has become a global "pandemic" due to its extraordinary speed and scale of transmission. According to the World Health Organization ("WHO") Director-General, the WHO is deeply concerned by both the alarming levels of spread and severity of COVID-19. During the Class Period, the defendants capitalized on widespread COVID-19 fears by falsely claiming that Inovio had developed a vaccine for COVID-19.

The Class Period commences on February 14, 2020, when Inovio Chief Executive Officer, J. Joseph Kim ("Kim"), appeared on Fox Business News with Neal Cavuto, and stated that Inovio had developed a COVID-19 vaccine "in a matter of about three hours once we had the DNA sequence from the virus" and "our goal is to start phase one human testing in the U.S. early this summer." In response, Inovio's stock price rose more than 10% over the next few trading days. Two weeks later, following a well-publicized March 2, 2020 meeting with President Donald J. Trump to discuss the COVID-19 outbreak, Kim again claimed that Inovio had developed a COVID-19 vaccine, stating "we were able to fully construct our vaccine within three hours . . . . Our plan is to start [U.S. based COVID-19 trials] in April of this year." The market responded favorably to Kim's statement and Inovio's stock price more than quadrupled from $4.28 per share on February 28, 2020, and continued to increase in the following weeks, reaching an intra-day high of $19.36 on March 9, 2020.

According to the complaint, on March 9, 2020, before trading commenced, Citron Research ("Citron") exposed the defendants' misstatements, calling for an SEC investigation into Inovio's "ludicrous and dangerous claim that they designed a [COVID-19] vaccine in 3 hours." Following this news, Inovio's stock price plummeted from its March 9 opening price of $18.72 per share to close at $9.83. On March 10, 2020, Inovio's stock price fell from its $9.30 per share opening price to close at $5.70 per share. The two-day drop wiped out approximately $643 million in market capitalization for Inovio, marking a 71% decline from its Class Period high. In a message to shareholders that same day, Inovio attempted to blunt the Citron revelations, but only highlighted its own misstatements, admitting that it had not developed a COVID-19 vaccine but rather had merely "designed a vaccine construct" – i.e., a precursor for a vaccine – and that it believed it had a "viable approach to address the COVID-19 outbreak."

The complaint alleges that, throughout the Class Period, the defendants falsely: (1) described their product as a fully completed vaccine when it was nothing of the sort; (2) claimed they had developed the vaccine in a matter of hours, which is a scientific impossibility; and (3) stated that they would be able to begin human trials in April 2020 when they had no reason to believe that they would have the necessary regulatory approvals to do so.

If you wish to discuss this securities fraud class action lawsuit or have any questions concerning this notice or your rights or interests with respect to this litigation, please contact Kessler Topaz Meltzer & Check (James Maro, Jr., Esq. or Adrienne Bell, Esq.) at (844) 877-9500 (toll free) or (610) 667-7706, or via e-mail at info@ktmc.com.

Inovio investors may, no later than May 12, 2020, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, or other counsel, or may choose to do nothing and remain an absent class member. A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. In order to be appointed as a lead plaintiff, the Court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.

Kessler Topaz Meltzer & Check prosecutes class actions in state and federal courts throughout the country involving securities fraud, breaches of fiduciary duties and other violations of state and federal law. Kessler Topaz Meltzer & Check is a driving force behind corporate governance reform, and has recovered billions of dollars on behalf of institutional and individual investors from the United States and around the world. The firm represents investors, consumers and whistleblowers (private citizens who report fraudulent practices against the government and share in the recovery of government dollars). The complaint in this action was not filed by Kessler Topaz Meltzer & Check. For more information about Kessler Topaz Meltzer & Check, please visit www.ktmc.com.

CONTACT:

Kessler Topaz Meltzer & Check, LLP
James Maro, Jr., Esq.
Adrienne Bell, Esq.
280 King of Prussia Road
Radnor, PA 19087
(844) 877-9500 (toll free)
(610) 667-7706
info@ktmc.com

SOURCE: Kessler Topaz Meltzer & Check, LLP

ReleaseID: 582750

CIR Shareholder Alert: Bronstein, Gewirtz & Grossman, LLC Notifies Shareholders of Investigation of CIRCOR International, Inc. and Encourages Investors to Contact the Firm

NEW YORK, NY / ACCESSWIRE / March 26, 2020 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of CIRCOR International, Inc. ("CIRCOR" or "the Company") (NYSE:CIR). Investors who purchased CIRCOR securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: www.bgandg.com/cir.

The investigation concerns whether CIRCOR and certain of its officers and/or directors have violated federal securities laws.

On March 2, 2020, CIRCOR announced that it would delay the filing of its financial report for the quarter and year ended December 31, 2019, citing material weaknesses in its internal control over financial reporting and the need for additional time to evaluate the impact of those weaknesses. CIRCOR also announced an independent investigation into accounting and financial reporting at one of its discontinued operations in order to determine whether there are any matters which could have a material impact on the Company's financial results. On this news, CIRCOR's stock price fell sharply during intraday trading on March 3, 2020.

If you are aware of any facts relating to this investigation, or purchased CIRCOR shares, you can assist this investigation by visiting the firm's site: www.bgandg.com/cir. You can also contact Peretz Bronstein or his Investor Relations Analyst, Yael Hurwitz of Bronstein, Gewirtz & Grossman, LLC: 212-697-6484.

Bronstein, Gewirtz & Grossman, LLC is a corporate litigation boutique. Our primary expertise is the aggressive pursuit of litigation claims on behalf of our clients. In addition to representing institutions and other investor plaintiffs in class action security litigation, the firm's expertise includes general corporate and commercial litigation, as well as securities arbitration. Attorney advertising. Prior results do not guarantee similar outcomes.

CONTACT:

Bronstein, Gewirtz & Grossman, LLC
Peretz Bronstein or Yael Hurwitz
212-697-6484 | info@bgandg.com

SOURCE: Bronstein, Gewirtz & Grossman, LLC
 

ReleaseID: 582757

KushCo Holdings Announces New Strategic Plan, Leadership Changes and Significant Cost-Cutting Efforts to Accelerate Path to Positive Adjusted EBITDA

New Strategic Plan Focuses on Aligning Deeper with the MSOs, LPs, and Leading Brands; Significantly Reducing and Right-Sizing the Company's Cost Structure; and Achieving Positive Adjusted EBITDA
Christopher Tedford to Step Down as Chief Financial Officer
Company's Executive Vice President of Corporate Development Stephen Christoffersen Appointed as New Chief Financial Officer
Latest Reduction in Force of Nearly 50 Employees to Generate an Approximate Annualized Cash Compensation Savings of $4.0 Million

CYPRESS, CA / ACCESSWIRE / March 26, 2020 / KushCo Holdings, Inc. (OTCQX:KSHB) (''KushCo'' or the ''Company''), the premier producer of ancillary products and services to the legal cannabis and CBD industries, today announced the unveiling of its new strategic plan for achieving positive adjusted EBITDA, including recent changes to its leadership team and significant cost-cutting efforts to right-size the business.

KushCo's Strategic Plan to Achieve Positive Adjusted EBITDA

"After more than doubling sales in each of the last five years, we entered fiscal 2020 embarking on a new strategy to rationalize all aspects of our operations, align ourselves deeper with the best and promising cannabis and CBD operators, and pave an achievable pathway toward near-term profitability," said Nick Kovacevich, KushCo's Co-founder, Chairman and Chief Executive Officer. "While this has been the Company's focus since the start of the new fiscal year in September 2019, executing against this strategy has become paramount to everyone within the organization, as the COVID-19 pandemic creates ever-increasing uncertainty in the cannabis industry, especially for many of our smaller customers that were already struggling financially following the aftermath of the black market vape crisis and ensuing cash crunch. As a result, we have taken quick and decisive steps these past six months, and especially these past few weeks, to significantly reduce our overhead, streamline our warehouses, reduce our inventory, and drastically alter our sales strategy and resources to rely even less on the smaller operators, while doubling down on our efforts to solidify and strengthen our core base of large MSOs, LPs, and leading brands. All these positive changes put us on more solid financial footing and give us an accelerated path toward achieving positive adjusted EBITDA."

The Company has developed and formalized a comprehensive strategic plan to focus its resources on a more optimal customer group, realign its sales organization, reduce its warehouse footprint, simplify its SKU count and inventory position, and implement additional headcount reductions.

The Company's new strategic plan includes:

Focusing deeper on larger and more financially stable MSOs, LPs, and leading brands (the "Core" customers): The Company's customer base has gradually shifted in the past few years from predominantly smaller and regional operators ("Legacy" customers) to financially stronger and more creditworthy MSOs, LPs, and leading brands ("Core" customers). These Core customers generated approximately $52 million of revenue, or 80% of total revenue, in the Company's first half of fiscal 2020. KushCo believes that having the vast majority of its revenue being driven by this more stable, predictable, creditworthy, and financially stronger customer base will allow the Company to better forecast demand, reduce inventory and warehouse space, improve collections and cash flow, and benefit from further expansion and consolidation in the marketplace.

Implementing a more profitable, efficient, and automated approach toward doing business with Legacy customers: KushCo intends to continue providing the highest level of customer service to its Legacy customers, but in more efficient and cost-effective ways that minimize working capital and operating expenses. Going forward, transactions with these customers will be moved towards a cash-only basis, will not include any custom projects, and will be performed through a general customer service support line without a dedicated sales representative or project manager. KushCo expects to retain most of the revenue from this customer group, while also significantly reducing costs.

Right-sizing the workforce to better align the Company's resources with its elevated focus on Core customers: Due to the Company's elevated focus on Core customers and more automated approach to transacting with Legacy customers, KushCo took further steps to reduce headcount that was not essential to the new strategic plan. In March 2020, KushCo completed another round of layoffs, letting go 49 employees, which the Company expects will result in approximately $4.0 million in annual cash compensation savings. The reduction in force encompassed a broad spectrum of divisions, including sales representatives that were formerly catering directly to Legacy customers, who will now be better serviced through automation. In total, the Company has reduced its headcount by approximately 50% since September 2019, which it expects will result in an aggregate annual cash compensation savings of approximately $12 million.

Consolidating warehouse footprint and reducing other operating expenses to drive further cost savings: The Company is making further progress toward consolidating and rationalizing its warehouse footprint, while ensuring that all customers continue to receive the same premier level of service and responsiveness. In addition, KushCo is in the process of substantially reducing its third-party consulting costs, as well as other operating expenses.

For its fiscal first quarter ended November 30, 2019, the Company's selling, general and administrative (SG&A) expenses were $21.1 million, or $15.6 million when excluding non-cash expenses, including depreciation, amortization, and stock-based compensation. Following the full execution of its plan, which the company expects to complete before the start of its fiscal 2020 in September, the Company expects its quarterly SG&A expenses to reduce to $12.5 million in fiscal Q4 2020, which is a decrease of approximately 40% compared to its SG&A expenses in fiscal Q1 2020. Excluding non-cash expenses, the Company expects its quarterly SG&A expenses to reduce to $9.5 million in fiscal Q4 2020, which is a decrease of approximately 40% compared to its SG&A expenses in fiscal Q1 2020.

Jason Vegotsky, KushCo's President and Chief Revenue Officer, added: "We are fortunate to have started this new strategic plan already having secured many of the most valued MSOs, LPs, and leading brands in our client roster. However, executing a broad reorganization and cost-cutting initiative-something that is largely in our control-remains the critical next step, and we're encouraged to have made significant inroads on that front, which should greatly reduce the revenue levels required to achieve positive adjusted EBITDA. We believe it will take a few months for this restructuring to fully take shape, but expect the end result to be a much leaner, stronger, and more focused organization that is truly aligned on all aspects-revenue and cost-with the industry's best and leading operators. Ultimately, we believe we have the right strategy, liquidity, customers, and talent to execute on our plan and to ensure we are in prime position to continue capturing the industry's robust growth."

KushCo expects to provide more details on its new strategic plan when it reports its complete fiscal second quarter 2020 financial results in April 2020.

Changes to the Leadership Team

In order to better execute on its new strategic plan, the Company also implemented changes to its leadership team. Stephen Christoffersen, Executive Vice President of Corporate Development, has been named the Company's new Chief Financial Officer, replacing Christopher Tedford, who will be leaving the Company, effective April 10, 2020.

Mr. Christoffersen has served as KushCo's Executive Vice President of Corporate Development since November 2018, where he oversees and manages the Company's business development functions, including expanding KushCo's hemp trading and retail services divisions. Since Mr. Christoffersen joined the Company, he has played an active role in KushCo's capital raising efforts, partnerships, and strategic investments, including securing the Company's line of credit with Monroe Capital, its partnership with C.A. Fortune, and its investment in and partnership with Xtraction Services, where he currently serves as a Board member. He brings nearly 15 years of capital markets, portfolio management, and corporate development experience to the role of Chief Financial Officer. Prior to joining KushCo, he managed a $500 million equity portfolio for a large bank and served as the Chief Financial Officer of an emerging beef jerky brand, as well as advised on M&A and fundraising initiatives for several seed and growth stage companies. He received his Chartered Financial Analyst designation in 2015 and holds a Bachelor of Science in Finance from the University of Nevada, Las Vegas.

"On behalf of the entire Board and management team, I am truly excited to welcome Stephen as our new Chief Financial Officer," said Kovacevich. "Stephen has made a resounding impact since joining the team less than two years ago, constantly finding new ways to add value on multiple fronts. His intimate knowledge of our business and financial state-as well as his active role in launching and developing our newer, higher-margin services-makes him a perfect candidate to step into this role as we enter this next chapter of our evolution-one that will require a broad cross-section of skills and experiences, including an ability to wear multiple hats and embrace our new ethos of ‘doing more with less.'"

Mr. Tedford had been serving as KushCo's Chief Financial Officer since November 2018, and played an instrumental role in bolstering the Company's financial and risk management capabilities, treasury management, and strategic financial planning and reporting.

Kovacevich continued: "We are beyond grateful for Chris' many contributions and insight while serving as the Company's Chief Financial Officer. When he joined KushCo in late 2018, we were running a very lean finance staff that was grappling with the challenging dynamics of a start-up operating in a hyper growth and constantly evolving industry. Under his leadership, we have been able to significantly bolster our finance and accounting capabilities, and put standards and processes in place designed to ensure we have a well-oiled financial reporting, forecasting, and budgeting machine across the entire organization. I am encouraged by the solid platform Chris and his team have put in place, which can now be easily picked up by Stephen, for whom we have the utmost confidence. Overall, we thank Chris for all his service and wish him nothing but the best in his next endeavors."

About KushCo Holdings

KushCo Holdings, Inc. (OTCQX:KSHB) (www.kushco.com) is the premier producer of ancillary products and services to the legal cannabis and CBD industries. KushCo Holdings' subsidiaries and brands provide product quality, exceptional customer service, compliance knowledge and a local presence in serving its diverse customer base.

Founded in 2010, KushCo Holdings has now sold more than 1 billion units to growers, processors and producers across North America, South America, and Europe.

The Company has been featured in media nationwide, including CNBC, Fox News, Yahoo Finance, Cheddar, Los Angeles Times, TheStreet.com, and Entrepreneur, Inc Magazine. While KushCo Holdings provides products and solutions to customers in the cannabis and CBD industries, it has no direct involvement with the cannabis plant or any products that contain THC.

For more information, visit www.kushco.com or call (888) 920-5874.

Forward-Looking Statements

This press release may include predictions, estimates or other information that might be considered forward-looking within the meaning of applicable securities laws. While these forward-looking statements represent the Company's current judgments, they are subject to risks and uncertainties that could cause actual results to differ materially, including the ongoing effects of the COVID-19 pandemic on the economy and consumer and business practices. You are cautioned not to place undue reliance on these forward-looking statements, which reflect the opinions of the Company's management only as of the date of this release. Please keep in mind that the Company is not obligating itself to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events. When used herein, words such as: "potential," "look forward," "expect," "anticipate," "project," "should," "believe," or variations of such words and similar expressions are intended to identify forward-looking statements. Factors that could cause actual results to differ materially from those contemplated in any forward- looking statements made by the Company herein are often discussed in the Company's filings with the United States Securities and Exchange Commission (SEC), which are available at: www.sec.gov, and on the Company's website, at: www.kushco.com.

KushCo Holdings Contact

Investor Contact:

Najim Mostamand, CFA
Director of Investor Relations
714-539-7653
ir@kushco.com

SOURCE: KushCo Holdings, Inc.

ReleaseID: 582756

ReShape Lifesciences Announces Fourth Quarter and Full Year 2019 Financial Results

SAN CLEMENTE, CA / ACCESSWIRE / March 26, 2020 / ReShape Lifesciences Inc. (OTCQB:RSLS), a leading developer and distributor of minimally invasive medical devices to treat obesity and metabolic diseases, today reported financial results for the three months and full year ended December 31, 2019.

Recent Highlights and Accomplishments

Recognized revenue of $4.1 million in the fourth quarter of 2019 and $15.1 million for the full year 2019, growing full year 2019 U.S. Lap-Band sales and reversing years of declining revenues
Implemented cost savings initiatives resulting in a 3-times reduction of net cash burn
Expanded Lap-Band System presence through new digital media launches and private presentations of long-term safety and efficacy data at key international surgical conferences
Completed transition of international Lap-Band System sales to ReShape and established key distributor relationships
Continued enrollment of patients for the Endure clinical study of the ReShape Gastric Vest in Europe
Removed and converted warrant liability to a $50.0 million net equity improvement, thus improving balance sheet and taking shareholder equity from negative to positive
Completed recent $3.5 million term loan financing in March 2020

"2019 was a transformational year for ReShape. We made great strides with our new technology, team and strategy," said Bart Bandy, President and Chief Executive Officer at ReShape Lifesciences. "We have successfully reengaged the bariatric community with a comprehensive Lap-Band product and service offering, resulting in the growth of US sales after years of decline. In addition, we took significant steps to reduce expenses and strengthen our balance sheet to position the company for future growth and we remain confident that we can continue to drive sales and offer addtional comprehensive solutions to expand our presence as a preferred corporate partner for weight-loss surgeons and their teams."

Fourth Quarter 2019 Financial Results

Revenue for the three months ended December 31, 2019, was $4.1 million compared to $3.5 million in revenues for the three months ended September 30, 2019.

Gross profit for the fourth quarter of 2019 was $2.1 million compared to $2.1 million for the three months ended September 30, 2019.

Sales and marketing expenses for the three months ended December 31, 2019 were $1.5 million compared to $0.9 million for the three months ended September 30, 2019.

General and administrative expenses were $3.0 million for the fourth quarter of 2019 compared to $4.4 million for the three months ended September 30, 2019.

Research and development expenses were $0.2 million for the fourth quarter of 2019 compared to $0.9 million for the three months ended September 30, 2019.

Non-GAAP adjusted EBIDTA loss was $1.4 million for the fourth quarter of 2019 compared to a loss of $4.0 million for the three months ended September 30, 2019.

Full Year 2019 Financial Results

Revenue for 2019 was $15.1 million compared to $0.6 million in revenues for 2018.

Gross profit for 2019 was $9.3 million compared to $0.4 million for 2018.

Sales and marketing expenses were $4.8 million for 2019 compared to $5.2 million for 2018.

General and administrative expenses were $17.2 million for 2019 compared to $14.0 million for 2018.

Research and development expenses were $3.1 million for 2019 compared to $5.7 million for 2018.

Non-GAAP adjusted EBITDA loss was $11.6 million for 2019 compared to a loss of $21.0 million for 2018.

As of December 31, 2019, the Company had cash and cash equivalents and restricted cash totaling $3.0 million, net of their $2.0 million scheduled payment for the purchase of the Lap-Band System.

Conference Call

Management will host an investment community conference call today beginning at 1:30 p.m. Pacific Time 4:30 p.m. Eastern Time. Individuals interested in listening to the conference call may do so by dialing (877)280-7473 for domestic callers or (707)287-9370 for international callers, using Conference ID: 7189904. To listen to a live webcast or a replay, please visit the investor relations section of the Company website at: http://ir.reshapelifesciences.com/.

About ReShape Lifesciences Inc.

ReShape Lifesciences™ is a medical device company focused on technologies to treat obesity and metabolic diseases. The FDA-approved LAP-BAND® Adjustable Gastric Banding System is designed to provide minimally invasive long-term treatment of severe obesity and is an alternative to more invasive surgical stapling procedures such as the gastric bypass or sleeve gastrectomy. The ReShape Vest™ System is an investigational, minimally invasive, laparoscopically implanted medical device that wraps around the stomach, emulating the gastric volume reduction effect of conventional weight-loss surgery, and is intended to enable rapid weight loss in obese and morbidly obese patients without permanently changing patient anatomy.

Forward-Looking Safe Harbor Statement:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as "expect," "plan," "anticipate," "could," "may," "intend," "will," "continue," "future," other words of similar meaning and the use of future dates. These forward-looking statements are based on the current expectations of our management and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others: risks and uncertainties related to our acquisition of the LAP-BAND system; our ability to continue as a going concern if we are unable to improve our operating results or obtain additional financing; risks related to ownership of our securities as a result of our delisting from the Nasdaq Capital Market; our proposed ReShape Vest product may not be successfully developed and commercialized; our limited history of operations; our losses since inception and for the foreseeable future; our limited commercial sales experience; the competitive industry in which we operate; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for our ReShape Vest and any modifications to our vBloc system and LAP-BAND system; physician adoption of our products; our ability to obtain third party coding, coverage or payment levels; ongoing regulatory compliance; our dependence on third party manufacturers and suppliers; the successful development of our sales and marketing capabilities; our ability to raise additional capital when needed; international commercialization and operation; our ability to attract and retain management and other personnel and to manage our growth effectively; potential product liability claims; the cost and management time of operating a public company; potential healthcare fraud and abuse claims; healthcare legislative reform; and our ability to obtain and maintain intellectual property protection for our technology and products. These and additional risks and uncertainties are described more fully in the Company's filings with the Securities and Exchange Commission, particularly those factors identified as "risk factors" in our annual report on Form 10-K filed May 16, 2019 and subsequent quarterly reports on Form 10-Q. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise, except as required by law.

Non-GAAP Disclosures

In addition to the financial information prepared in conformity with GAAP, we provide certain historical non-GAAP financial information. Management believes that these non-GAAP financial measures assist investors in making comparisons of period-to-period operating results and that, in some respects, these non-GAAP financial measures are more indicative of the Company's ongoing core operating performance than their GAAP equivalents.

Management believes that the presentation of this non-GAAP financial information provides investors with greater transparency and facilitates comparison of operating results across a broad spectrum of companies with varying capital structures, compensation strategies, derivative instruments, and amortization methods, which provides a more complete understanding of our financial performance, competitive position, and prospects for the future. However, the non-GAAP financial measures presented in this Form 10-K have certain limitations in that they do not reflect all of the costs associated with the operations of our business as determined in accordance with GAAP. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. Further, the non-GAAP financial measures presented by the Company may be different from similarly named non-GAAP financial measures used by other companies.

Adjusted EBITDA

Management uses Adjusted EBITDA in its evaluation of the Company's core results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Adjusted EBITDA is defined as net loss before interest, taxes, depreciation and amortization, stock-based compensation, changes in fair value of liability warrants and other one-time costs. Management uses Adjusted EBITDA in its evaluation of the Company's core results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. Further, the non-GAAP financial measures presented by the Company may be different from similarly named non-GAAP financial measures used by other companies.

Investor Contact:

Thomas Stankovich
Chief Financial Officer
ReShape Lifesciences Inc.
949-276-6042
tstankovich@ReShapeLifesci.com

Consolidated Balance Sheets
(in thousands, except share and per share amounts)

 

 
December 31,
 
 
December 31,
 

 

 
2019
 
 
2018
 

ASSETS

 
 
 
 
 
 

Current assets:

 
 
 
 
 
 

Cash and cash equivalents

 

2,935
 
 

5,548
 

Restricted cash

 
 
50
 
 
 

 

Accounts and other receivables (net of allowance for bad debts of $709 at December 31, 2019 and $236 at December 31, 2018)

 
 
4,096
 
 
 
917
 

Finished goods inventory

 
 
1,317
 
 
 
985
 

Prepaid expenses and other current assets

 
 
1,711
 
 
 
1,269
 

Total current assets

 
 
10,109
 
 
 
8,719
 

Property and equipment, net

 
 
16
 
 
 
64
 

Operating lease right-of-use assets

 
 
758
 
 
 

 

Other intangible assets, net

 
 
28,674
 
 
 
36,927
 

Other assets

 
 
99
 
 
 
563
 

Total assets

 

39,656
 
 

46,273
 

LIABILITIES AND STOCKHOLDERS' EQUITY

 
 
 
 
 
 
 
 

Current liabilities:

 
 
 
 
 
 
 
 

Accounts payable

 

4,264
 
 

1,628
 

Accrued and other liabilities

 
 
3,821
 
 
 
4,829
 

Warranty liability, current

 
 
105
 
 
 

 

Asset purchase consideration payable, current

 
 
1,909
 
 
 
1,907
 

Operating lease liabilities, current

 
 
291
 
 
 

 

Total current liabilities

 
 
10,390
 
 
 
8,364
 

Asset purchase consideration payable, noncurrent

 
 
2,728
 
 
 
4,403
 

Operating lease liabilities, noncurrent

 
 
477
 
 
 

 

Warranty liability, noncurrent

 
 
1,253
 
 
 

 

Deferred income taxes

 
 
702
 
 
 
1,844
 

Total liabilities

 
 
15,550
 
 
 
14,611
 

Commitments and contingencies

 
 
 
 
 
 
 
 

Stockholders' equity:

 
 
 
 
 
 
 
 

Preferred stock, 5,000,000 shares authorized:

 
 
 
 
 
 
 
 

Series B convertible preferred stock, $0.01 par value; 3 and 159 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively

 
 

 
 
 

 

Series C convertible preferred stock, $0.01 par value; 95,388 shares issued and outstanding at December 31, 2019 and December 31, 2018

 
 
1
 
 
 
1
 

Common stock, $0.001 par value; 275,000,000 shares authorized at December 31, 2019 and December 31, 2018; 391,739 and 73,092 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively

 
 

 
 
 

 

Additional paid-in capital

 
 
517,310
 
 
 
450,651
 

Accumulated deficit

 
 
(493,197
)
 
 
(418,990
)

Accumulated other comprehensive loss

 
 
(8
)
 
 

 

Total stockholders' equity

 
 
24,106
 
 
 
31,662
 

Total liabilities and stockholders' equity

 

39,656
 
 

46,273
 

RESHAPE LIFESCIENCES INC.
Consolidated Statements of Operations
(in thousands, except share and per share amounts)

 

 
Year Ended December 31,
 

 

 
2019
 
 
2018
 

Revenue

 

15,089
 
 

607
 

Cost of revenue

 
 
5,784
 
 
 
164
 

Gross profit

 
 
9,305
 
 
 
443
 

Operating expenses:

 
 
 
 
 
 
 
 

Sales and marketing

 
 
4,847
 
 
 
5,237
 

General and administrative

 
 
17,224
 
 
 
14,025
 

Research and development

 
 
3,121
 
 
 
5,722
 

Impairment of intangible assets and goodwill

 
 
6,588
 
 
 
14,005
 

Legal settlement

 
 
1,500
 
 
 

 

Loss on disposal of assets

 
 
486
 
 
 

 

Total operating expenses

 
 
33,766
 
 
 
38,989
 

Operating loss

 
 
(24,461
)
 
 
(38,546
)

Other expense (income), net:

 
 
 
 
 
 
 
 

Interest expense, net

 
 
451
 
 
 
12
 

Loss on extinguishment of debt

 
 
71
 
 
 

 

Warrant expense

 
 
49,027
 
 
 
145
 

Gain on foreign currency exchange

 
 
(247
)
 
 

 

Offering costs and other, net

 
 
1,337
 
 
 
11
 

Loss from continuing operations before income taxes

 
 
(75,100
)
 
 
(38,714
)

Income tax benefit

 
 
893
 
 
 
3,447
 

Loss from continuing operations

 
 
(74,207
)
 
 
(35,267
)

Loss from discontinued operations, net of tax

 
 

 
 
 
(45,885
)

Net loss

 
 
(74,207
)
 
 
(81,152
)

Less: Down round adjustments for convertible preferred stock and warrants

 
 

 
 
 
(3,079
)

Net loss attributable to common shareholders

 

(74,207
)
 

(84,231
)

Net loss per share – basic and diluted:

 
 
 
 
 
 
 
 

Continuing operations

 

(42.93
)
 

(4,107.77
)

Discontinued operations

 
 

 
 
 
(4,915.37
)

Net loss per share – basic and diluted

 

(42.93
)
 

(9,023.14
)

Shares used to compute basic and diluted net loss per share

 
 
1,728,722
 
 
 
9,335
 

The following table contains a reconciliation of non-GAAP net loss to GAAP net loss attributable to common stockholders for the years ended December 31, 2019 and 2018 (in thousands).

 

 
Years Ended December 31,
 

 

 
2019
 
 
2018
 

GAAP net loss attributable to common stockholders

 

(74,207
)
 

(35,267
)

Adjustments:

 
 
 
 
 
 
 
 

Interest expense (income) net:

 
 
451
 
 
 
12
 

Income tax provision (benefit)

 
 
(893
)
 
 
(3,447
)

Depreciation and amortization

 
 
1,706
 
 
 
440
 

Stock compensation expense

 
 
2,311
 
 
 
3,098
 

Loss on debt extinguishment

 
 
71
 
 
 

 

Liability warrant expense

 
 
49,027
 
 
 
145
 

Loss on litigation settlement

 
 
1,500
 
 
 

 

Impairment of intangible assets and goodwill

 
 
6,588
 
 
 
14,005
 

Loss on disposal of assets

 
 
486
 
 
 

 

Other

 
 
1,337
 
 
 
11
 

Non-GAAP loss

 

(11,623
)
 

(21,003
)

The following table contains a reconciliation of non-GAAP net loss to GAAP net loss attributable to common stockholders for each of the fiscal quarters of 2019 (in thousands):

 

 
For the three months ended
 

(Unaudited)

 
March 31,
2019
 
 
June 30,
2019
 
 
September 30,
2019
 
 
December 31,
2019
 

GAAP net loss attributable to common stockholders

 

(4,476
)
 

(15,920
)
 

(28,754
)
 

(25,057
)

Adjustments:

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Interest expense (income) net:

 
 
103
 
 
 
213
 
 
 
74
 
 
 
61
 

Income tax provision (benefit)

 
 

 
 
 
(586
)
 
 

 
 
 
(307
)

Depreciation and amortization

 
 
433
 
 
 
430
 
 
 
423
 
 
 
420
 

Stock compensation expense

 
 
1,256
 
 
 
727
 
 
 
(497
)
 
 
825
 

Loss on debt extinguishment

 
 

 
 
 
71
 
 
 

 
 
 

 

Liability warrant expense

 
 
130
 
 
 
4,127
 
 
 
22,564
 
 
 
22,206
 

Loss on litigation settlement

 
 

 
 
 

 
 
 
1,500
 
 
 

 

Impairment of intangible assets

 
 

 
 
 
6,588
 
 
 

 
 
 

 

Loss on disposal of assets

 
 

 
 
 

 
 
 

 
 
 
486
 

Other

 
 
(3
)
 
 
612
 
 
 
727
 
 
 
1
 

Non-GAAP loss

 

(2,557
)
 

(3,738
)
 

(3,963
)
 

(1,365
)

SOURCE: ReShape Lifesciences Inc.

ReleaseID: 582723