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Guardion Health Sciences, Inc. (GHSI)

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Previous Close1.5600
Open1.5400
Bid0.0000 x 1000
Ask0.0000 x 1400
Day's Range1.4700 - 1.5600
52 Week Range0.9900 - 8.4000
Volume413,879
Avg. Volume1,972,954
Market Cap36.396M
Beta (5Y Monthly)0.08
PE Ratio (TTM)N/A
EPS (TTM)-0.6010
Earnings DateNov 12, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target EstN/A
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  • Guardion Health Sciences Initiates Placebo-Controlled Clinical Trial Involving Proprietary GlaucoCetin® Product
    GlobeNewswire

    Guardion Health Sciences Initiates Placebo-Controlled Clinical Trial Involving Proprietary GlaucoCetin® Product

    Clinical Trial Intended to Demonstrate Improved Visual Function in Glaucoma Patients Taking GlaucoCetin®SAN DIEGO, May 03, 2021 (GLOBE NEWSWIRE) -- Guardion Health Sciences, Inc. (Nasdaq: GHSI) (“Guardion” or the “Company”), a clinical nutrition and diagnostics company that develops clinically supported nutrition, medical foods, supplements and medical devices, announced the initiation of a placebo-controlled clinical trial to study the impact on visual function, as measured by visual field sensitivity, in patients with glaucoma after a 12-week regimen of GlaucoCetin®. GlaucoCetin is the Company’s proprietary medical food designed to provide support for mitochondrial activity in optic nerve cells. Mitochondrial dysfunction and loss of activity is now thought to be a key factor for vision loss from glaucoma, as well as other common debilitating eye diseases. The 12-week double-blind study will evaluate 100 patients randomized to receive either GlaucoCetin or a placebo at a 1:1 ratio. Patients will be recruited based on two additional subgroups: those with central vision loss and those with peripheral vision loss. In addition to the primary endpoint of visual field testing, secondary end points include evaluating changes in quality of life, electrophysiology, contrast sensitivity and blood levels of antioxidants, particularly glutathione. Contrast sensitivity is being evaluated using proprietary testing technology from VectorVision, a wholly owned subsidiary of the Company. “This study, which we are proud to have initiated with one of the leading university-based eye research centers on the East Coast, supports our overall strategy of evaluating the efficacy of our medical foods through rigorously designed clinical studies that demonstrate patient benefits in the real-world,” commented David Evans, Ph.D., Guardion’s Chief Science Officer. About Guardion Health Sciences Guardion Health Sciences, Inc. (Nasdaq: GHSI), is a clinical nutrition and diagnostics company. Guardion offers a portfolio of science-based, clinically supported nutritional supplements, medical foods, and diagnostic products that support healthcare professionals, their patients, and consumers in achieving health goals. Guardion’s commercial and developmental initiatives are supported by equally impressive scientific and medical advisory boards, led by seasoned business executives and physicians with many years of experience. This combination of expertise and scientific knowledge forms the foundation of Guardion’s growing position within the eye care industry and the clinical nutrition marketplace. Information and risk factors with respect to Guardion and its business, including its ability to successfully develop and commercialize its proprietary products and technologies, may be obtained in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”) at www.sec.gov. Forward-Looking Statement Disclaimer With the exception of the historical information contained in this news release, the matters described herein may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. These statements involve unknown risks and uncertainties that may individually or materially impact the matters discussed herein for a variety of reasons that are outside the control of the Company, including, but are not limited to, the Company’s ability to raise sufficient financing to implement its business plan, the integration of a new management team, the impact of the COVID-19 pandemic on the Company’s business, operations and the economy in general, the Company’s ability to successfully develop and commercialize its proprietary products and technologies, and the Company’s ability to maintain compliance with Nasdaq’s listing requirements. Readers are cautioned not to place undue reliance on these forward-looking statements, as actual results could differ materially from those described in the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company’s filings with the SEC, which are available at the SEC’s website (www.sec.gov). The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Relations Contact:CORE IRScott Arnold516-222-2560scotta@coreir.com Media Relations Contact:Jules AbrahamDirector of Public RelationsCORE IR917-885-7378julesa@coreir.com

  • Guardion Health Sciences Announces Financial Results for the Three Months and Year Ended December 31, 2020
    GlobeNewswire

    Guardion Health Sciences Announces Financial Results for the Three Months and Year Ended December 31, 2020

    Company Provides Corporate Update and Overview of Growth PlansSAN DIEGO, March 26, 2021 (GLOBE NEWSWIRE) -- Guardion Health Sciences, Inc. (Nasdaq: GHSI) (“Guardion” or the “Company”), a clinical nutrition and diagnostics company that develops science-based, clinically supported nutritional supplements, medical foods, and diagnostic products, announced financial results for the three months and year ended December 31, 2020. Effective March 1, 2021, the Company amended its Certificate of Incorporation to effectuate a 1-for-6 reverse split of its outstanding common stock. Accordingly, all share and per share amounts included herein have been retroactively adjusted to reflect the reverse stock split for all periods presented. Financial highlights for the year ended December 31, 2020 include the following: Total revenue of $1,889,844 for the year ended December 31, 2020, as compared to $902,937 for the year ended December 31, 2019, an increase of approximately 109%. Net loss for the year ended December 31, 2020 of $(8,571,657) or $(0.60) per share, as compared to a net loss of $(10,878,308) or $(1.79) per share for the year ended December 31, 2019. Cash balance at December 31, 2020 of $8,518,732. Pro forma cash balance at December 31, 2020 of $45,727,241, after giving effect to the sale of common stock and the exercise of warrants during January and February 2021. Corporate highlights for the fourth quarter ended December 31, 2020 include the following: The Company appointed seasoned nutritional products industry veteran Bret Scholtes as President and Chief Executive Officer, and as a member of the Board of Directors. The Company retained an investment banking firm to act as its exclusive financial advisor to assist management and the Board of Directors in the identification and evaluation of strategic transactions to enhance shareholder value. Ho Wah Genting Berhad, the Company’s exclusive Malaysian distributor, advised Guardion that Astramern Astra H (formerly Astramern Nutra H), an immune support dietary supplement designed and produced by the Company, was granted product registration approval by the Malaysian National Pharmaceutical Regulatory Agency. Previously, in August 2020, the Company had announced the product registration approval of the vitamin formulation Astramern NutraV. New data was published in the journal Nutrients (published October 26, 2020) that the efficacy of the Company’s Lumega-Z® compared to the current standard of care, the AREDS-2 soft gel supplement (marketed under the PreserVision® brand by Bausch + Lomb) in patients with vision problems associated with eye disease. Lumega-Z® demonstrated statistically significant vision improvements in both eyes at six months (p < 0.001), and a positive linear trend with treatment time (p < 0.001), with benefits evident after just three months. This compares to no significant change (p > 0.05) provided by the AREDS-2 supplement gel cap formulation. A trademark was issued for “NutriGuard” on October 27, 2020 by the U.S. Patent and Trademark Office under Class 5 – nutritional dietary supplements. Bret Scholtes, Guardion’s President and Chief Executive Officer, commented, “As it was for many companies, 2020 was a year of transition and challenge on multiple fronts. I joined the Company in January 2021 to lead the effort to build Guardion into a leading clinical nutrition company with the objective that it become a top performing growth company. As a start, our team has taken the first three months of 2021 to begin to assess the business, the core fundamentals, and the market opportunity for the Company’s products and services. I am excited by the prospects of the business, evidenced, in part, by the increased revenue on a year-over-year basis and the critical third-party validation of our science that we received in 2020. We plan to continue such efforts in future periods.” Mr. Scholtes continued, “We have much to do in the coming months before we will be in a position to implement and accelerate our growth initiatives. We are focused on building a strong foundation by developing a business model and infrastructure that are designed for long-term commercial success. We have started this process by concentrating on certain key areas, including our business strategy, go-to-market capabilities, scientific affairs and human capital. We are also beginning the process of establishing our nascent brands and identifying core customer bases where we can accelerate our marketing efforts once our clinical support and scientific evidence is in place.” Mr. Scholtes concluded, “This process will take time, but we have already taken two important steps to build a stronger company. We have raised sufficient capital to not only fund the process -- but also to accelerate the process -- of building the Company through organic growth and carefully considered strategic acquisitions. Our recent at-the-market equity financings in 2021 generated gross proceeds of $35,000,000 and the exercise of warrants in 2021 generated net proceeds of $3,608,509. In addition, our recent reverse stock split enabled us to come into full compliance with Nasdaq’s continued listing rules regarding minimum bid stock price. Over the long-term, the key to our success will be to create value in well-differentiated and robust brands through strong clinically proven claims that address consumer needs in growing markets, both domestically and internationally. We are committed to bringing compelling products to market under meaningful and differentiated brands supported by strong science. We appreciate the patience and support of our shareholders as we focus on the Company’s evolution during 2021.” Financial Results Years Ended December 31, 2020 and 2019 Total revenue for the year ended December 31, 2020 increased by approximately 109% to $1,889,844, as compared total revenue for the year ended December 31, 2019 of $902,937, primarily due to an initial order from the Company’s Malaysian distributor of $890,000 for a novel nutraceutical formulation designed to support the body’s immune function. Operating expenses for the year ended December 31, 2020 were $8,494,940, as compared to operating expenses for the year ended December 31, 2019 of $11,058,559. Operating expenses in 2020 included a $615,936 reduction to expense associated with the settlement with the former Chief Executive Officer, while operating expenses in 2019 included a goodwill impairment charge of $1,563,520. Net loss for the year ended December 31, 2020 was $(8,571,657), which included inventory write-downs of $971,719, offset by a net gain from the settlement with the former Chief Executive Officer of $615,936. Net loss for the year ended December 31, 2019 was $(10,878,308), which included a goodwill impairment charge of $1,563,520. Taking all of these factors into account, net loss decreased by approximately 21% in 2020 as compared to 2019. About Guardion Health Sciences Guardion Health Sciences, Inc. (NASDAQ: GHSI), is a clinical nutrition and diagnostics company. Guardion’s portfolio of science-based, clinically supported nutrition, medical foods, and diagnostic products support healthcare professionals, their patients, and consumers in achieving health goals. Guardion’s commercial and developmental initiatives are supported by equally impressive scientific and medical advisory boards, led by seasoned business executives and physicians with many years of experience. This combination of expertise and scientific knowledge forms the foundation of Guardion’s growing position within the eye care industry and the clinical nutrition marketplace. Information and risk factors with respect to Guardion and its business, including its ability to successfully develop and commercialize its proprietary products and technologies, may be obtained in the Company’s filings with the U. S. Securities and Exchange Commission (the “SEC”) at www.sec.gov. Forward-Looking Statement Disclaimer With the exception of the historical information contained in this news release, the matters described herein may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward- looking in nature and not historical facts, although not all forward-looking statements include the foregoing. These statements involve unknown risks and uncertainties that may individually or materially impact the matters discussed herein for a variety of reasons that are outside the control of the Company, including, but not limited to, the Company’s ability to raise sufficient financing to implement its business plan, the impact of the COVID-19 pandemic on the Company’s business, operations and the economy in general, and the Company’s ability to successfully develop and commercialize its proprietary products and technologies. Readers are cautioned not to place undue reliance on these forward- looking statements, as actual results could differ materially from those described in the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company’s filings with the SEC, which are available at the SEC’s website (www.sec.gov). The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Relations Contact:CORE IRScott Arnold516-222-2560scotta@coreir.com Media Relations Contact:Jules AbrahamDirector of Public RelationsCORE IR917-885-7378julesa@coreir.com Guardion Health Sciences, Inc. Consolidated Balance Sheets December 31, 2020 2019 Assets Current assets Cash $8,518,732 $11,115,502 Accounts receivable 11,248 78,337 Inventories 384,972 310,941 Prepaid expenses 179,931 362,938 Total current assets 9,094,883 11,867,718 Deposits 11,751 11,751 Property and equipment, net 285,676 374,638 Operating lease right-of-use asset, net 418,590 572,714 Intangible assets, net 50,000 50,000 Total assets $9,860,900 $12,876,821 Liabilities and Stockholders’ Equity Current liabilities Accounts payable and accrued liabilities $608,313 $129,132 Accrued expenses 127,637 116,211 Payable to former officer 148,958 - Derivative warrant liability 25,978 13,323 Operating lease liability - current 162,845 151,568 Total current liabilities 1,073,731 410,234 Operating lease liability – long-term 271,903 434,747 Total liabilities 1,345,634 844,981 Commitments and contingencies Stockholders’ Equity Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding at December 31, 2020 and December 31, 2019 - - Common stock, $0.001 par value; 250,000,000 shares authorized; 15,170,628 and 12,497,094 shares issued and outstanding at December 31, 2020 and December 31, 2019 15,171 12,497 Additional paid-in capital 62,583,423 57,531,014 Accumulated deficit (54,083,328) (45,511,671) Total stockholders’ equity 8,515,266 12,031,840 Total liabilities and stockholders’ equity $9,860,900 $12,876,821 Guardion Health Sciences, Inc. Consolidated Statements of Operations Years Ended December 31, 2020 2019 Revenue Medical foods $1,609,482 $444,657 Medical devices 275,862 434,010 Other 4,500 24,270 Total revenue 1,889,844 902,937 Cost of goods sold Medical foods (includes inventory write-down of $760,488 during the year ended December 31, 2020) 1,599,510 155.212 Medical devices (includes inventory write-down of $211,231 during the year ended December 31, 2020) 344,647 178,815 Other 2,478 7,288 Total cost of goods sold 1,946,635 341,315 Gross profit (loss) (56,791) 561,622 Operating expenses Research and development 160,978 194,311 Sales and marketing 1,450,205 1,874,901 General and administrative 7,450,245 7,425,827 Costs related to resignation of former officer (including the reversal of previously recognized stock compensation expense of $965,295 during the year ended December 31, 2020) (615,936) - Loss on sales of equipment 18,500 - Equipment impairment 30,948 - Goodwill impairment - 1,563,520 Total operating expenses 8,494,940 11,058,559 Loss from operations (8,551,731) (10,496,937) Other income (expenses): Interest expense (7,271) (258,365)Finance cost upon issuance of warrants - (415,955)Change in fair value of derivative liability (12,655) 292,949 Total other income (expenses) (19,926) (381,371) Net loss (8,571,657) (10,878,308) Net loss per common share – basic and diluted $(0.60) $(1.79)Weighted average common shares outstanding – basic and diluted 14,256,856 6,078,014 Guardion Health Sciences, Inc. Operations by Segment For the Year Ended December 31, 2020 Corporate MedicalFoods andNutraceuticals MedicalDevices Total Revenue $4,500 $1,609,482 $275,862 $1,889,844 Cost of goods sold 2,478 1,599,510 344,647 1,946,635 Gross profit (loss) 2,022 9,972 (68,785) (56,791) Stock compensation expense 544,127 - - 544,127 Operating expenses 3,757,945 3,892,899 299,969 7,950,813 Loss from operations $(4,300,050) $(3,882,927) $(368,754) $(8,551,731) As of December 31, 2020 Corporate MedicalFoods andNutraceuticals MedicalDevices Total Current assets Cash $8,518,732 $- $- $8,518,732 Inventories, net - 254,879 130,093 384,972 Other - 89,333 101,846 191,179 Total current assets 8,518,732 344,212 231,939 9,094,883 Right of use asset - 374,447 44,143 418,590 Property and equipment, net - 135,641 150,035 285,676 Intangible assets, net - 50,000 - 50,000 Other - 11,751 - 11,751 Total assets $8,518,732 $916,051 $426,217 $9,860,900

  • Guardion Health Sciences Regains Compliance with Nasdaq Minimum Bid Price Rule
    GlobeNewswire

    Guardion Health Sciences Regains Compliance with Nasdaq Minimum Bid Price Rule

    SAN DIEGO, March 16, 2021 (GLOBE NEWSWIRE) -- Guardion Health Sciences, Inc. (Nasdaq: GHSI) (“Guardion” or the “Company”), a clinical nutrition and diagnostics company that develops clinically supported nutritional supplements, medical foods, and medical devices, announced that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market pursuant to Listing Rule 5550(a)(2) (the “Minimum Bid Price Rule”). On March 15, 2021, Guardion received a letter from the Office of General Counsel of The Nasdaq Stock Market LLC (“Nasdaq”) stating that because Guardion’s Company’s common stock (the “Common Stock”) had a closing bid price at or above $1.00 per share for a minimum of ten (10) consecutive trading days, its Common Stock had regained compliance with Nasdaq’s Minimum Bid Price Rule. On September 20, 2019, the Company received notice from Nasdaq indicating that, based upon the closing bid price of the Common Stock, the Company no longer satisfied the Minimum Bid Price Rule. The Company was afforded 180 calendar days, or until March 18, 2020, to regain compliance with the Minimum Bid Price Rule. Thereafter, the Company was afforded a second 180 calendar day compliance period (which 180-day period was extended due to circumstances related to COVID-19), or until November 30, 2020, to regain compliance with the Minimum Bid Price Rule. The Company was unable to regain compliance with the Minimum Bid Price Rule by November 30, 2020. Accordingly, on December 1, 2020, the Company received a letter from Nasdaq notifying it that its Common Stock would be subject to delisting from Nasdaq unless the Company timely requested a hearing before a Nasdaq Listing Qualifications Panel (the “Panel”). The Company timely requested the hearing. Following the hearing, on January 26, 2021, the Company received written notification that the Panel had granted the Company an extension for continued listing through March 15, 2021. As referenced above, Nasdaq determined that the Company complied with the Panel’s decision and has regained compliance. Accordingly, Nasdaq has closed the compliance review. About Guardion Health Sciences Guardion Health Sciences, Inc. (NASDAQ: GHSI), is a clinical nutrition and diagnostics company. Guardion offers a portfolio of science-based, clinically supported nutrition, medical foods, and diagnostic products that support healthcare professionals, their patients, and consumers in achieving health goals. Guardion’s commercial and developmental initiatives are supported by equally impressive scientific and medical advisory boards, led by seasoned business executives and physicians with many years of experience. This combination of expertise and scientific knowledge forms the foundation of Guardion’s growing position within the eye care industry and the clinical nutrition marketplace. Information and risk factors with respect to Guardion and its business, including its ability to successfully develop and commercialize its proprietary products and technologies, may be obtained in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”) at www.sec.gov. Forward-Looking Statement Disclaimer With the exception of the historical information contained in this news release, the matters described herein may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. These statements involve unknown risks and uncertainties that may individually or materially impact the matters discussed herein for a variety of reasons that are outside the control of the Company, including, but are not limited to, the Company’s ability to raise sufficient financing to implement its business plan, the integration of a new management team, the impact of the COVID-19 pandemic on the Company’s business, operations and the economy in general, the Company’s ability to successfully develop and commercialize its proprietary products and technologies, and the Company’s ability to maintain compliance with Nasdaq’s listing requirements. Readers are cautioned not to place undue reliance on these forward-looking statements, as actual results could differ materially from those described in the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company’s filings with the SEC, which are available at the SEC’s website (www.sec.gov). The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Relations Contact:CORE IRScott Arnold516-222-2560scotta@coreir.com Media Relations Contact:Jules AbrahamDirector of Public RelationsCORE IR917-885-7378julesa@coreir.com