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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Guardion Health Sciences Inc | NASDAQ:GHSI | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.04 | -0.50% | 7.96 | 8.00 | 8.14 | 8.14 | 7.90 | 7.90 | 1,733 | 18:34:18 |
RECENT HIGHLIGHTS:
MANAGEMENT COMMENTARY:
Michael Favish, Guardion’s Chief Executive Officer, commented, “We are pleased with the progress we made in the third-quarter, which was highlighted by revenue growth in our flagship medical food Lumega-Z. As a result of the recent commercial introduction of the VectorVision CSV-2000 device to the marketplace in September 2019, we anticipate positive momentum from this business in 2020.”
“Our team’s continued focus on successful patient outcomes and product excellence has already resulted in a strong start to the fourth quarter, with improving revenue in October 2019 as compared to October 2018. We are focused on expanding our position as one of the most trusted names in the ocular health care field, consistently bringing new innovations to market that can have a measurable impact on vision therapy and preservation over many years. With no direct competition in the glaucoma therapy market, and no effective treatments for age-related macular degeneration, Guardion’s products represent unique, market-leading treatments, and we are beginning to see this realization through wider adoption of our products by physicians and customers.”
“Furthermore, we anticipate that the NutriGuard transaction will fast-track our direct-to- consumer platform, enabling wider distribution and awareness of our products to NutriGuard’s long-standing customer and doctor base. Overall, we will continue to invest in our infrastructure to ensure that we are able to properly scale operations in anticipation of the growing demand for our products. I am enthusiastic about the long-term growth prospects for our growing product portfolio and remain committed to setting the industry’s bar for consistency and execution in the dynamic and rapidly growing world of ocular health,” concluded Mr. Favish.
FINANCIAL HIGHLIGHTS (Unaudited):
Third Quarter - Three Months Ended September 30, 2019:
Nine Months Ended September 30, 2019:
Liquidity:
As of September 30, 2019, the Company had cash of $5,554,960, working capital of $5,672,704, and total assets of $8,955,046. On October 30, 2019, the Company completed an underwritten public offering consisting of 24,500,000 shares of common stock (or pre-funded warrants to purchase common stock in lieu thereof) and Series B warrants to purchase up to 24,500,000 shares of the Company’s common stock, which generated net proceeds to the Company of approximately $7,200,000.
About Guardion Health Sciences, Inc.
Guardion is an ocular health sciences company that develops, formulates and distributes condition-specific medical foods supported by evidence-based protocols, with a lead medical food product, Lumega-Z®, that addresses a depleted macular protective pigment, a known risk factor for age-related macular degeneration (“AMD”) and a significant component of functional vision performance. Guardion has also developed a proprietary medical device, the MapcatSF®, which accurately measures the macular pigment density, thereby providing the only two-pronged evidence-based protocol for the treatment of a depleted macular protective pigment. 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 Securities and Exchange Commission (“SEC”) at www.sec.gov.
About VectorVision®
VectorVision®, operating through a wholly owned subsidiary of the Company, specializes in the standardization of contrast sensitivity, glare sensitivity, low contrast acuity, and ETDRS acuity vision testing. Its patented standardization system provides the practitioner or researcher the ability to delineate very small changes in visual capability, either as compared to the population or from visit to visit. VectorVision®’s CSV-1000 device is considered the standard of care for clinical trials. The Company recently completed the development of the CSV-2000, which will be the only computer-generated vision testing instrument available that can provide the Company’s proprietary, industry-standard contrast sensitivity test.
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. 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 and its 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.
Company Contact: Michael Favish Chief Executive Officer Telephone: (858) 605-9055 x 201 E-mail: mfavish@guardionhealth.com
Investor Relations Contact:
Matthew AbenantePorter, LeVay & Rose, Inc.Telephone: (212) 564-4700E-mail: guardion@plrinvest.com
The following tables should be read in conjunction with the footnotes accompanying the condensed consolidated financial statements contained in the Quarterly Report on Form 10-Q filed today with the Securities and Exchange Commission.
Guardion Health Sciences, Inc.Condensed Consolidated Balance Sheets
September 30, | December 31, | |||||||
2019 | 2018 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets | ||||||||
Cash | $ | 5,554,960 | $ | 670,948 | ||||
Accounts receivable | 21,927 | 28,203 | ||||||
Inventories | 320,355 | 357,997 | ||||||
Prepaid expenses | 234,384 | 47,773 | ||||||
Total current assets | 6,131,626 | 1,104,921 | ||||||
Deposits | 11,751 | 11,751 | ||||||
Property and equipment, net | 389,074 | 274,804 | ||||||
Right of use asset, net | 563,948 | - | ||||||
Deferred offering costs | - | 270,000 | ||||||
Intangible assets, net | 295,127 | 456,104 | ||||||
Goodwill | 1,563,520 | 1,563,520 | ||||||
Total assets | $ | 8,955,046 | $ | 3,681,100 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities | ||||||||
Accounts payable and accrued liabilities | $ | 218,815 | $ | 413,925 | ||||
Accrued expenses and deferred rent | 63,964 | 81,412 | ||||||
Derivative warrant liability | 47,118 | - | ||||||
Lease liability – current | 129,025 | - | ||||||
Total current liabilities | 458,922 | 495,337 | ||||||
Lease liability – long term | 447,292 | - | ||||||
Total liabilities | 906,214 | 495,337 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ Equity | ||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized | - | - | ||||||
Common stock, $0.001 par value; 90,000,000 shares authorized; 50,482,562 and 20,564,328 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 50,483 | 20,564 | ||||||
Additional paid-in capital | 49,454,265 | 37,798,562 | ||||||
Accumulated deficit | (41,455,916 | ) | (34,633,363 | ) | ||||
Total stockholders’ equity | 8,048,832 | 3,185,763 | ||||||
Total liabilities and stockholders’ equity | $ | 8,955,046 | $ | 3,681,100 |
Guardion Health Sciences, Inc.Condensed Consolidated Statements of Operations
Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
Revenue | ||||||||||||||||
Medical foods | $ | 112,957 | $ | 86,082 | $ | 317,338 | $ | 238,213 | ||||||||
Vision testing diagnostics | 44,705 | 208,148 | 337,531 | 469,834 | ||||||||||||
Other | 3,500 | - | 9,800 | - | ||||||||||||
Total revenue | 161,162 | 294,230 | 664,669 | 708,047 | ||||||||||||
Cost of goods sold | ||||||||||||||||
Medical foods | 41,655 | 37,076 | 120,608 | 110,462 | ||||||||||||
Vision testing diagnostics | 27,922 | 88,330 | 136,958 | 181,999 | ||||||||||||
Other | 1,422 | - | 3,981 | - | ||||||||||||
Total cost of goods sold | 70,999 | 125,406 | 261,547 | 292,461 | ||||||||||||
Gross profit | 90,163 | 168,824 | 403,122 | 415,586 | ||||||||||||
Operating expenses | ||||||||||||||||
Research and development | 31,897 | 4,793 | 138,613 | 199,500 | ||||||||||||
Sales and marketing | 448,387 | 240,028 | 1,246,846 | 1,224,491 | ||||||||||||
General and administrative | 2,022,367 | 1,064,645 | 5,427,573 | 3,779,325 | ||||||||||||
Total operating expenses | 2,502,651 | 1,309,466 | 6,813,032 | 5,203,316 | ||||||||||||
Loss from operations | (2,412,488 | ) | (1,140,642 | ) | (6,409,910 | ) | (4,787,730 | ) | ||||||||
Other (income) expense: | ||||||||||||||||
Interest expense | 4,205 | 545 | 255,842 | 2,090 | ||||||||||||
Finance cost upon issuance of warrants | - | - | 415,955 | - | ||||||||||||
Change in fair value of derivative warrants | (31,322 | ) | - | (259,154 | ) | - | ||||||||||
Costs associated with extension of warrant expiration dates | - | 1,007,006 | - | 1,501,397 | ||||||||||||
Total other (income) expense | (27,117 | ) | 1,007,551 | 412,643 | 1,503,487 | |||||||||||
Net loss | $ | (2,385,371 | ) | $ | (2,148,193 | ) | $ | (6,822,553 | ) | $ | (6,291,217 | ) | ||||
Net loss per common share – basic and diluted | $ | (0.07 | ) | $ | (0.11 | ) | $ | (0.26 | ) | $ | (0.31 | ) | ||||
Weighted average common shares outstanding – basic and diluted | 36,035,309 | 20,164,761 | 26,483,713 | 20,162,354 |
Guardion Health Sciences, Inc.Condensed Consolidated Statements of Cash Flows
Nine Months EndedSeptember 30, | ||||||||
2019 | 2018 | |||||||
(Unaudited) | (Unaudited) | |||||||
Operating Activities | ||||||||
Net loss | $ | (6,822,553 | ) | $ | (6,291,217 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 209,813 | 223,014 | ||||||
Amortization of debt discount | 250,000 | - | ||||||
Accrued interest expense included in notes payable | 788 | - | ||||||
Amortization of right of use asset | 93,222 | - | ||||||
Stock-based compensation | 299,684 | 1,405,222 | ||||||
Stock-based compensation – officer and director | 1,788,751 | - | ||||||
Non-cash financing costs – derivative liability | 415,955 | - | ||||||
Change in fair value of warrants – derivative liability | (259,154 | ) | - | |||||
Costs associated with extension of warrant expiration dates | - | 1,501,397 | ||||||
Changes in operating assets and liabilities: | ||||||||
(Increase) decrease in - | ||||||||
Accounts receivable | 6,275 | 55,761 | ||||||
Inventories | 37,642 | (226,537 | ) | |||||
Deposits and prepaid expenses | (186,611 | ) | 77,147 | |||||
Lease liability | (86,902 | ) | - | |||||
Increase (decrease) in - | ||||||||
Accounts payable and accrued expenses | 75,439 | (43,117 | ) | |||||
Accrued expenses and deferred rent | (11,399 | ) | 10,390 | |||||
Net cash used in operating activities | (4,189,050 | ) | (3,287,940 | ) | ||||
Investing Activities | ||||||||
Purchase of property and equipment | (163,105 | ) | (228,311 | ) | ||||
Purchase of intellectual property | - | (50,000 | ) | |||||
Net cash used in investing activities | (163,105 | ) | (278,311 | ) | ||||
Financing Activities | ||||||||
Proceeds from initial public offering | 3,888,000 | - | ||||||
Proceeds from follow-on public offering | 4,944,340 | - | ||||||
Proceeds from issuance of convertible notes | 250,000 | - | ||||||
Proceeds from issuance of promissory note | 100,000 | - | ||||||
Payments on promissory note | (100,548 | ) | - | |||||
Payments on line of credit | - | (30,535 | ) | |||||
Proceeds from exercise of warrants | 154,375 | 1,460 | ||||||
Decrease in due to related parties | - | (38,114 | ) | |||||
Net cash provided by (used in) financing activities | 9,236,167 | (67,189 | ) | |||||
Cash: | ||||||||
Net increase (decrease) | 4,884,012 | (3,633,440 | ) | |||||
Balance at beginning of period | 670,948 | 4,735,230 | ||||||
Balance at end of period | $ | 5,554,960 | $ | 1,101,790 | ||||
Supplemental disclosure of cash flow information: | ||||||||
Cash paid for- | ||||||||
Interest | $ | - | $ | - | ||||
Income taxes | $ | - | $ | - | ||||
Non-cash financing activities: | ||||||||
Fair value of warrant liability issued in connection with issuance of convertible notes | $ | 436,034 | $ | - | ||||
Recording of lease asset and liability upon adoption of ASU 2016-02 | $ | 663,218 | $ | - | ||||
Reclass of warrant liability to equity | $ | 359,683 | $ | - | ||||
Fair value of common stock issued upon conversion of common stock and accrued interest | $ | 250,788 | $ | - | ||||
Reclass of deferred offering cost to equity | $ | 270,000 | $ | - |
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