MARKET

GHSI

GHSI

Guardion Health Sciences
NASDAQ

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Guardion Health Sciences Q3 EPS $(0.02) Up From $(0.07) YoY, Sales $253.00K Up From $161.16K YoY
Guardion Health Sciences (NASDAQ:GHSI) reported quarterly losses of $(0.02) per share. This is a 71.43 percent increase over losses of $(0.07) per share from the same period last year. The company reported $253.00
Benzinga · 11/12 21:20
Guardion Health Sciences Announces Financial Results for the Three Months and Nine Months Ended September 30, 2020
Guardion Also Provides Corporate Update SAN DIEGO, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Guardion Health Sciences, Inc. (Nasdaq: GHSI) (“Guardion” or the “Company”), a specialty health sciences company that develops clinically supported nutrition, medical foods and medical devices, with a focus in the ocular health marketplace, announced financial results for the three months and nine months ended September 30, 2020, and is also providing a corporate update.Financial and corporate highlights for the three months and nine months ended September 30, 2020 include the following: * Total revenue was approximately $253,000 for the three months ended September 30, 2020, as compared to approximately $161,000 for the three months ended September 30, 2019, an increase of 57%. * Medical foods sales are up 26% for the three months ended September 30, 2020, as compared to the three months ended September 30, 2019. * Medical devices sales are up 147% for the three months ended September 30, 2020, as compared to the three months ended September 30, 2019. * Net loss for the three months ended September 30, 2020 was approximately ($2,143,000) or ($0.02) per share, as compared to a net loss of approximately ($2,385,000) or ($0.07) per share for the three months ended September 30, 2019. * Cash balance at September 30, 2020 was approximately $9,800,000. * Ho Wah Genting Berhad (“HWGB”), the Company’s distributor in Malaysia, has received product registration approval from the Malaysian National Pharmaceutical Regulatory Agency (“NPRA”) for Astramern Nutra V, an immune support dietary supplement designed and produced by Guardion; approval for Astramern Nutra H, an herb formulation that HWGB intends to market together with Astramern Nutra V, continues to be pending with the Malaysian NPRA. * Publication of promising new data in the journal Nutrients (published   October 26, 2020), which compared the efficacy of the Company’s Lumega-Z® 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 0.05). * Initiation of investigator-initiated clinical trials designed to evaluate the impact of Lumega-Z® on the restoration of the macular pigment and its relationship to the stabilization or recovery of vision in patients with eye disease. It is believed that depletion of the macular pigment at the back of the eye is a risk factor for vision problems related to age-related macular degeneration (“AMD”), glaucoma and other serious eye diseases. * Guardion retained the investment banking firm Corporate Finance Associates (“CFA”) 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. * At the Company’s Annual Meeting of Shareholders held on October 29, 2020, shareholders approved all four matters presented for approval. * Trademark for “NutriGuard” issued on October 27, 2020 by the U.S. Patent and Trademark Office under Class 5 – nutritional dietary supplements. David Evans, Ph.D., Guardion’s interim President and Chief Executive Officer, and Chief Science Officer, commented, “As we continue to develop our investment into clinical research to build strong differentiated brand claims, we are entering the commercial phase of our business development process. Despite a challenging environment with the COVID-19 pandemic, which has slowed our progress both in terms of connecting directly with doctors and consumers, as well as conducting day-to-day business, sales continue to be up year-over-year. Over the course of this pandemic, it has become increasingly clear that there are multiple business opportunities for Guardion to explore, including enhancing our digital distribution channels and e-commerce platform and expanding our international distribution opportunities. In addition, we are working closely with CFA to identify and evaluate strategic transactions and opportunities to enhance shareholder value.”Dr. Evans concluded, “We continue to receive third party validation of our products, including recently published studies, in the journal Nutrients, showing superior efficacy of our proprietary formulation, Lumega-Z®, in terms of both absorption level and improvement in visual function, versus PreserVision®, the industry leading AREDS-2 gel cap product formulation. These results clearly support our brand messaging and offer an evidenced-based foundation to support our evolving product development strategies. We will continue our commitment to scientific and clinical validation of our proprietary products and to report on our results to our shareholders as this information occurs.”Results of Annual Meeting of Shareholders and Nasdaq Delisting IssueOn October 29, 2020, the Company held its annual meeting of shareholders (the “Meeting”). At the Meeting, the Company’s shareholders approved all four proposals, including extending the discretionary authority previously granted to the Board of Directors to effect a “reverse stock split,” at a specific ratio within a range of no split and one-for-thirty (1-for-30), with the exact ratio to be determined by the Board of Directors in its sole discretion on or before October 29, 2021.Since the Company does not intend to execute a reverse stock split prior to November 30, 2020, Guardion expects to receive a notice of delisting from The Nasdaq Capital Market (“Nasdaq”) shortly after November 30, 2020 because the trading price of the Company’s common stock does not meet the $1.00 per share minimum bid price requirement.The Company intends to appeal any notice of delisting that Nasdaq issues after November 30, 2020 to request a further extension of time (not to exceed 180 days from the date of the notice of delisting) to regain compliance with the $1.00 minimum bid price requirement. Such temporary relief would allow the Company additional time to execute on its business initiatives to generate greater shareholder value, which the Company hopes would then be reflected by an increase in the price of the Company’s common stock. During the appeal process, the Company’s common stock will continue to be listed on Nasdaq.A permanent delisting from Nasdaq could adversely impact the liquidity of the Company’s common stock and limit the ability of the Company to raise additional capital in the future.Financial ResultsThree Months Ended September 30, 2020Total revenue for the three months ended September 30, 2020 increased by approximately 57% to approximately $253,000, as compared total revenue for the three months ended September 30, 2019 of approximately $161,000, primarily due to increased sales of medical foods and nutraceuticals and medical devices in the current period.Operating expenses for the three months ended September 30, 2020 decreased by approximately 8% to approximately $2,291,000 as compared to operating expenses for the three months ended September 30, 2019 of approximately $2,503,000, primarily due to a decrease in selling and marketing expenses in the current period.Operating loss for the three months ended September 30, 2020 decreased by approximately $260,000 to approximately ($2,152,000), as compared to the operating loss for the three months ended September 30, 2019 of approximately ($2,412,000). Net loss for the three months ended September 30, 2020 was approximately ($2,143,000), or ($0.02) per share, as compared to a net loss of approximately ($2,385,000), or ($0.07) per share, for the three months ended September 30, 2019.Nine Months Ended September 30, 2020Total revenue for the nine months ended September 30, 2020 increased by approximately 154% to approximately $1,690,000, as compared to total revenue for the nine months ended September 30, 2019 of approximately $665,000. This increase was primarily due to a large initial test order of a nutraceutical product placed by the Company’s Malaysian distributor of $890,000 that was recorded during the three months ended June 30, 2020 and increased sales of medical food product lines, partially offset by a decrease in medical device sales which were affected by the impact of COVID-19 closures during the nine months ended September 30, 2020.Operating expenses for the nine months ended September 30, 2020 decreased by approximately 12% to approximately $6,018,000, as compared to operating expenses for the nine months ended September 30, 2019 of approximately $6,813,000, primarily due to a reduction of approximately $965,000 in stock-based compensation cost related to a reversal of stock-based compensation as a result of the resignation of the Company’s former President and Chief Executive Officer in June 2020.Operating loss for the nine months ended September 30, 2020 decreased by approximately $1,214,000 to approximately ($5,196,000), as compared to the operating loss for the nine months ended September 30, 2019 of approximately ($6,410,000). Net loss for the nine months ended September 30, 2020 was approximately ($5,198,000), or ($0.06) per share, as compared to a net loss of approximately ($6,823,000), or ($0.26) per share, for the nine months ended September 30, 2019.About Guardion Health SciencesGuardion is a specialty health sciences company that develops clinically supported nutrition, medical foods and medical devices, with a focus in the ocular health marketplace. Located in San Diego, California, the Company combines targeted nutrition with innovative, evidence-based diagnostic technology. Guardion boasts impressive Scientific and Medical Advisory Boards. 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 IR Scott Arnold 516-222-2560 scotta@coreir.com Media Relations Contact: Jules Abraham Director of Public Relations CORE IR 917-885-7378 julesa@coreir.com  Guardion Health Sciences, Inc. Condensed Consolidated Balance Sheets    September 30, 2020  December 31, 2019   (Unaudited)     Assets                 Current assets        Cash$9,795,441  $11,115,502  Accounts receivable 22,849   78,337  Inventories, net 1,284,173   310,941  Prepaid expenses 231,621   362,938           Total current assets 11,334,084   11,867,718           Deposits 11,751   11,751  Property and equipment, net 305,600   374,638  Right-of-use asset, net 457,677   572,714  Intangible assets 50,000   50,000           Total assets$12,159,112  $12,876,821           Liabilities and Stockholders’ Equity                 Current liabilities        Accounts payable$576,890  $70,291  Accrued expenses 182,597   175,052  Due to former officer 230,208   -  Derivative warrant liability 7,519   13,323  Lease liability – current 159,962   151,568  Total current liabilities 1,157,176   410,234           Lease liability – long-term 313,909   434,747           Total liabilities 1,471,085   844,981           Commitments and contingencies                 Stockholders’ Equity                 Preferred stock, $0.001 par value; 10,000,000 shares authorized, no shares issued and outstanding -   -  Common stock, $0.001 par value; 250,000,000 shares authorized; 88,327,312 and 74,982,562 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively 88,327   74,983  Additional paid-in capital 61,308,938   57,468,528  Accumulated deficit (50,709,238)  (45,511,671)          Total stockholders’ equity 10,688,027   12,031,840           Total liabilities and stockholders’ equity$12,159,112  $12,876,821  Guardion Health Sciences, Inc. Condensed Consolidated Statements of Operations    Three Months Ended September 30,  Nine Months Ended September 30,   2020  2019  2020  2019   (Unaudited)  (Unaudited)  (Unaudited)  (Unaudited)  Revenue                Medical foods and nutraceuticals$142,556  $112,957  $1,446,584  $317,338  Medical devices 110,632   44,705   237,136   337,531  Other -   3,500   6,100   9,800  Total revenue 253,188   161,162   1,689,820   664,669                   Cost of goods sold                Medical foods and nutraceuticals 68,956   41,655   764,245   120,608  Medical devices 45,157   27,922   101,077   136,958  Other -   1,422   2,478   3,981  Total cost of goods sold 114,113   70,999   867,800   261,547                   Gross profit 139,075   90,163   822,020   403,122                   Operating expenses                Research and development 34,034   31,897   109,803   138,613  Sales and marketing 167,213   448,387   1,175,126   1,246,846  General and administrative 2,070,998   2,022,367   5,299,696   5,427,573  Costs related to resignation of former officer (including the reversal of previously recognized stock compensation expense of $965,295 during the nine months ended September 30, 2020) -   -   (615,936)  -  Loss on sale of equipment 18,500   -   18,500   -  Impairment loss on equipment -   -   30,948   -                   Total operating expenses 2,290,745   2,502,651   6,018,137   6,813,032                   Loss from operations (2,151,670)  (2,412,488)  (5,196,117)  (6,409,910)                  Other (income) expense:                Interest expense 3,716   4,205   7,254   255,842  Finance cost upon issuance of warrants -   -   -   415,955  Change in fair value of derivative warrants (11,892)  (31,322)  (5,804)   (259,154)                  Total other (income) expense 8,176   (27,117)   1,450   412,643                   Net loss$(2,143,494) $(2,385,371) $(5,197,567) $(6,822,553)                  Net loss per common share – basic and diluted$(0.02) $(0.07) $(0.06) $(0.26) Weighted average common shares outstanding – basic and diluted 88,320,523   36,035,309   84,530,367   26,483,713  Guardion Health Sciences, Inc. Operations by Segment (Unaudited)    For the Three Months Ended September 30, 2020   Corporate  Medical Foods and Nutraceuticals  Medical Devices Total              Revenue$-  $142,556  $110,632 $253,188                  Cost of goods sold -   68,956   45,157  114,113                  Gross profit -   73,600   65,475  139,075                  Operating expenses 1,202,402   1,081,897   6,446  2,290,745                  (Loss) income from operations$(1,202,402) $(1,008,296) $59,028 $(2,151,670)  For the Nine Months Ended September 30, 2020   Corporate  Medical Foods and Nutraceuticals  Medical Devices  Total               Revenue$6,100  $1,446,584  $237,136  $1,689,820                   Cost of goods sold 2,477   764,246   101,077   867,800                   Gross profit 3,623   682,338   136,059   822,020                   Operating expenses 2,655,107   3,146,514   216,516   6,018,137                   Loss from operations$(2,651,484) $(2,464,176) $(80,457) $(5,196,117)
GlobeNewswire · 11/12 21:05
Guardion Provides Answers to Frequently Asked Questions Regarding the Reasons for Approving the Reverse Stock Split Proposal at Upcoming 2020 Annual Stockholders’ Meeting
SAN DIEGO, Oct. 27, 2020 (GLOBE NEWSWIRE) -- Guardion Health Sciences, Inc. (“Guardion” or the “Company”) (NASDAQ: GHSI) is providing the following answers to frequently asked questions to its stockholders with regard to Proposal 4, which is being considered at the Company’s Annual Stockholders’ Meeting (the “Annual Meeting”) on October 29, 2020. Only stockholders of record on September 1, 2020, or the record date, are eligible to attend and vote on proposals presented at the Annual Meeting. The Board recommends a vote “FOR” Proposal 4. IMPORTANT REMINDER FOR GUARDION HEALTH SCIENCES, INC. STOCKHOLDERSTime is short – please vote your shares for the Annual Meeting of Stockholders on October 29, 2020Your vote may impact the value of your investment and the future of Guardion Health Sciences, Inc.KEY QUESTIONS OUR STOCKHOLDERS ARE ASKING REGARDING PROPOSAL 4: EXTENSION OF PREVIOUSLY AUTHORIZED REVERSE STOCK SPLITQuestionAnswer What will happen to Guardion Health Sciences, Inc. if Proposal 4 (Extension of Previously Authorized Reverse Stock Split) does not pass?  Your vote “FOR” Proposal 4 at the Annual Meeting of Stockholders on October 29, 2020 is critically important. Guardion Health Sciences, Inc. is at risk of being delisted from the Nasdaq Capital Market after November 30, 2020. Such delisting would adversely impact the liquidity of the Company’s common stock. Nasdaq requires that a Company maintain a minimum bid price of $1.00 per share. The Company is requesting from its stockholders an extension of its current authorization to effectuate a reverse stock split (which expires December 5, 2020) to increase the per share price and bid price of the Company’s common stock in order to regain compliance with the $1.00 minimum bid price requirement of Nasdaq. Additionally, a reverse stock split would potentially make the Company’s common stock more attractive to certain institutional investors, which would provide for a stronger investor base.   If Proposal 4 is not approved, the Board of Directors will initiate the previously authorized reverse stock split in November 2020 in order to comply with Nasdaq’s continued listing requirements.   If Proposal 4 is approved, we intend to appeal any delisting order that Nasdaq issues after November 30, 2020, as we believe that having the continuing discretionary authority to implement a reverse stock split will increase the Company’s chances of receiving temporary relief (not to exceed 180 days from November 30, 2020) from Nasdaq. Such temporary relief will allow the Company additional time to execute on its business initiatives to generate greater stockholder value and hopefully increase the Company’s common share price.   The board of directors believes it is in your best interest to vote “FOR” Proposal 4 today.    Didn’t Stockholders authorize a Reverse Stock Split at last year’s annual meeting? Why is my vote so important?  Yes, our stockholders authorized a reverse stock split at last year’s annual meeting of stockholders to be effectuated up until December 5, 2020. To date, the Board of Directors has not implemented the reverse stock split. We are requesting an extension of that previous authorization from our stockholders so that our Board of Directors retains the flexibility necessary should a reverse stock split become necessary.   Approval of Proposal 4 requires support by at least a majority of the outstanding shares of common stock. So, while many Guardion Health Sciences, Inc. stockholders have been highly supportive of Proposal 4 to date, we have not yet received enough votes to meet that high standard. That is why your vote matters, no matter how many or how few common shares you own.   What happens if I don’t vote?If you don’t vote or you abstain, it may count the same as a vote AGAINST Proposal 4.   Who can help me vote?Our proxy solicitor, Kingsdale Advisors, can assist you with voting your shares and any questions you may have – please see below for their contact information.   If I’ve already voted, can I change my vote?Yes. You may revoke your previously submitted proxy and reclaim your right to vote at any time before your proxy is voted at the Annual Meeting by submitting a later-dated proxy card or vote instruction form or by voting in person at the Annual Meeting. Your most current proxy card or Internet proxy is the one that will be counted. Your vote is important, so please act today!   Our proxy solicitor, Kingsdale Advisors, can assist in this process as well – please see below for their contact information. OUR PROXY SOLICITOR (KINGSDALE ADVISORS) STANDS READY TO ASSIST YOU WITH THIS IMPORTANT VOTE If you have questions about how to vote your shares, please contact our proxy solicitor, Kingsdale Advisors Strategic Stockholder Advisor and Proxy Solicitation Agent 745 Fifth Avenue, 5th Floor, New York, NY 10151 North American Toll Free Phone: 1-866-229-8874 Email: contactus@kingsdaleadvisors.com Call Collect Outside North America: +1 (416) 867-2272 * * *This communication may be deemed to be solicitation material in respect of Proposal 4. On September 8, 2020, Guardion Health Sciences, Inc. filed a definitive proxy statement with the Securities and Exchange Commission (“Commission”) in connection with the 2020 Annual Stockholders’ Meeting. STOCKHOLDERS ARE URGED TO READ CAREFULLY AND IN THEIR ENTIRETY THE PROXY STATEMENT AND ANY OTHER SOLICITING MATERIALS THAT ARE FILED WITH THE COMMISSION WHEN THEY BECOME AVAILABLE BECAUSE THESE DOCUMENTS CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY AND THE PROPOSALS TO BE VOTED UPON. The Company’s proxy statement and any other solicitation materials filed by the Company with the Commission can be obtained free of charge at the Commission’s website at www.sec.gov and at the investor relations section of the Company’s website at https://guardionhealth.com/sec-filings/. Stockholders may also write to the Company at the following address to request copies of these materials: Guardion Health Sciences, Inc., 15150 Avenue of Science, Suite 200, San Diego, California 92128. The Company, its directors and certain of its officers will be participants in the solicitation of proxies from stockholders in respect of the Annual Meeting. The Company has also engaged Kingsdale Advisors to aid in the solicitation of proxies. Detailed information regarding the identity of participants, and their respective interests in the Company by security holdings or otherwise, are set forth in the definitive proxy statement for the Annual Meeting. The contents of the websites referenced above are not deemed to be incorporated by reference into the proxy statement. Forward-Looking Statement DisclaimerWith the exception of the historical information contained in this press 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 IR Scott Arnold 516-222-2560 scotta@coreir.com
GlobeNewswire · 10/27 12:30
Why Guardion Health's Stock Is Trading Higher Today
Guardion Health Sciences (NASDAQ: GHSI) shares are trading higher on Monday after the company announced an investigator-initiated clinical trial of its Lumega-Z nutritional product.
Benzinga · 10/26 18:27
Guardion Health Sciences Announces Investigator-Initiated Clinical Trial Of Lumega-Z
Guardion Health Sciences Announces Investigator-Initiated Clinical Trial of Lumega-Z SAN DIEGO, Oct. 26, 2020 (GLOBE NEWSWIRE) -- Guardion Health Sciences, Inc. (NASDAQ:GHSI) ("Guardion" or the
Benzinga · 10/26 12:08
We Think Guardion Health Sciences (NASDAQ:GHSI) Needs To Drive Business Growth Carefully
Just because a business does not make any money, does not mean that the stock will go down. For example, biotech and...
Simply Wall St. · 10/05 14:15
Guardion Provides Update on Strategy, Business Plans and Initiatives
* Emphasis on Differentiation of Brands and Development and Integration of E-Commerce Platform   * Further Development of Clinically Supported Nutritional Products and Continued Expansion into International Markets   * Retention of Corporate Finance Associates to Advise on Strategic Transactions
GlobeNewswire · 10/05 12:30
Guardion Announces Virtual Annual Meeting of Stockholders
Annual stockholder meeting scheduled for Thursday, October 29, 2020 San Diego, California, Sept. 11, 2020 (GLOBE NEWSWIRE) -- Guardion Health Sciences, Inc.(“Guardion” or the “Company”) (NASDAQ: GHSI) announced that due to the public health concerns related to COVID-19 and to support the health and
GlobeNewswire · 09/11 21:20
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Institutions: 24
Institutional Holdings: 4.60M
% Owned: 5.21%
Shares Outstanding: 88.33M
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About GHSI
Guardion Health Sciences, Inc. is a health sciences company. The Company operates through two segments: Medical Foods and Vision Testing Diagnostics. Medical Foods segment develops, formulates and distributes condition-specific medical foods with an initial medical food product on the market under the brand name Lumega-Z that replenishes and restores the macular protective pigment. It has also developed a technology, the MapcatSF, which measures the macular pigment optical density (MPOD). It also provides GlaucoCetin, which is the vision-specific medical food designed to support and protect the mitochondrial function of optic nerve cells and improves blood flow in the ophthalmic artery in patients with glaucoma. The Company’s Vision Testing Diagnostics segment operates under the brand name VectorVision. It specializes in the standardization of contrast sensitivity, glare sensitivity, low contrast acuity and early treatment diabetic retinopathy study (ETDRS) visual acuity testing.
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