UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 29, 2024 GUARDION HEALTH SCIENCES, INC. (Exact name of registrant as specified in its charter) Delaware 001-38861 47-4428421 (I.R.S. Employer Identification No.) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of t ...

Viactiv® Product Line Generated Net Revenues of Approximately $11.9 Million for the Year Ended December 31, 2023, an Increase of Approximately 12% as Compared to the Year Ended December 31, 2022 HOUSTON, TEXAS, March 29, 2024 (GLOBE NEWSWIRE) -- Guardion Health Sciences, Inc. (NASDAQ:GHSI) ("Guardion" or the "Company"), a clinical nutrition company that offers a portfolio of science-based, clinically-supported products designed to support the health needs of consumers, healthcare professionals and providers ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission file number: 001-38861 GUARDION HEALTH SCIENCES, INC. (Exact name of registrant as specified in its charter) | Delaware | 47-4428421 | | --- | --- | | ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number: 001-38861 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 GUARDION HEALTH SCIENCES, INC. (Exact name of registrant as specified in its charter) | Delaware | 47-44284 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number: 001-38861 GUARDION HEALTH SCIENCES, INC. (Exact name of registrant as specified in its charter) | Delaware | 47-4428421 | ...

Financial Performance - Viactiv generated net revenues of approximately $3,091,000 for the three months ended March 31, 2023, accounting for 97% of total revenues[92] - Sales increased to $3,185,689 for the three months ended March 31, 2023, attributed to improved inventory levels and targeted retail price increases[99] - For the three months ended March 31, 2023, revenue from product sales was $3,185,689, an increase of $801,070 or 33.6% compared to $2,384,619 for the same period in 2022[130] - The company reported a net income of $533,091 for the three months ended March 31, 2023, compared to a net loss of $5,300,987 in the same period of 2022, marking an improvement of 894.4%[128] - Loss from operations improved to $(1,464,007) for the three months ended March 31, 2023, a decrease of $1,156,041 or 44% compared to $(2,620,048) in the same period of 2022[135] - The change in fair value of warrant derivative liabilities resulted in a gain of $1,898,100 for the three months ended March 31, 2023, compared to a loss of $2,682,500 in the same period of 2022, an increase of approximately $4,580,600[136] - Net income for the three months ended March 31, 2023, was $533,091, a significant improvement from a net loss of $(5,300,987) in the same period of 2022[137] Cost and Expenses - Cost of goods sold for the three months ended March 31, 2023, was $1,850,387, reflecting an increase of $562,225 or 43.7% from $1,288,162 in the prior year[131] - Gross profit for the three months ended March 31, 2023, was $1,335,302, representing a 21.8% increase from $1,096,457 in the same period of 2022[128] - Gross profit percentage decreased to 41.9% for the three months ended March 31, 2023, down from 45.9% in the same period of 2022, primarily due to increased retail customer trade promotions[132] - Operating expenses decreased by 24.7% to $2,799,309 for the three months ended March 31, 2023, down from $3,716,505 in the prior year[128] - Sales and marketing expenses decreased by $69,790 or 11% to $598,655 for the three months ended March 31, 2023, mainly due to reduced expenditures on the Viactiv product line[133] - General and administrative expenses decreased by $903,249 or 30% to $2,137,920 for the three months ended March 31, 2023, driven by reductions in various expense categories[134] - Research and development expenses surged by 837.6% to $62,734 for the three months ended March 31, 2023, compared to $6,691 in the same period of 2022[128] Product Development and Strategy - The company launched the Omega Boost Gel Bites product in 2022, which contains 1,200 mg of Omega-3 and is designed for total body support[95] - The company aims to strengthen its clinical nutrition strategy by advancing clinical evidence and increasing product awareness within the healthcare community[101] - The company plans to enhance its product strategy by developing new products and improving its brand strategy through better marketing and social media engagement[129] - The company has taken steps to strengthen its corporate foundation, including the acquisition of Viactiv and the launch of new products[124] Market Position and Strategic Initiatives - The acquisition of Activ Nutritional in June 2021 has significantly changed the company's financial position and market profile[90] - The company is evaluating strategic alternatives to maximize stockholder value, including potential sales or mergers[102] - A reverse stock split of 1-for-50 was approved to regain compliance with Nasdaq's minimum bid price requirement[108] Cash Flow and Working Capital - Cash and cash equivalents as of March 31, 2023, totaled $8,774,626, with working capital of $12,975,691[138] - Net cash used in operating activities decreased to $1,879,210 for the three months ended March 31, 2023, from $2,226,473 in the same period of 2022, a reduction of $347,263[142] - Net cash used in financing activities was $5,250,000 for the three months ended March 31, 2023, used entirely to repay holders of Preferred Stock issued in November 2022[144] Sales Growth - The company experienced a 36.8% growth in sales of its Viactiv line of products during the three months ended March 31, 2023, compared to the same period in 2022[130] - The Viactiv brand has a strong history of financial success, with revenues of approximately $2,385,000 for the same period in 2022, accounting for 95% of total revenues[92]

Revenue and Sales Performance - Viactiv generated net revenues of approximately $10,640,000 in 2022, accounting for 96% of the company's total revenues[217]. - For the year ended December 31, 2021, pro forma total revenues would have been approximately $12,766,000, with Viactiv products accounting for 94% of those revenues[217]. - For the year ended December 31, 2022, revenue increased by approximately $3,817,000 or 53% to $11,050,000 compared to $7,233,000 in 2021, primarily driven by the Viactiv product line[274]. - One customer accounted for 57% of total revenue in 2022, up from 49% in 2021, indicating a high concentration of revenue risk[247]. - As of December 31, 2022, one customer comprised approximately 88% of accounts receivable, highlighting significant reliance on a single customer[248]. Product Development and Launches - The company launched its new Omega Boost Gel Bites product in 2022, expanding its product line under the Viactiv brand[215]. - The launch of Viactiv® Omega Boost Gel Bites in February 2022 introduced a product with 1,200 mg of Omega-3, showing a 50% improvement in Omega-3 levels in just 4 weeks of usage during clinical trials[235][246]. - The company plans to focus on commercializing the Omega Boost Gel Bites and evaluating plans for another product launch in 2023[246]. - The company launched the Omega Boost Gel Bites in 2022, contributing to its product strategy aimed at increasing product breadth and market presence[270]. Financial Performance and Losses - The company expects to continue incurring substantial losses and negative cash flow from operations for the foreseeable future[219]. - For the year ended December 31, 2022, the net loss was approximately $14,922,000, a decrease of approximately $9,823,000 or 36% compared to a net loss of approximately $24,745,000 for the year ended December 31, 2021[287]. - The company incurred cash used in operating activities of approximately $7,447,000 for the year ended December 31, 2022, compared to approximately $10,644,000 for the prior year[294]. - Cost of goods sold for 2022 was approximately $6,529,000, an increase of 58% from $4,123,000 in 2021, largely due to costs associated with the Viactiv product line[275]. - Gross profit for 2022 was approximately $4,520,000, representing a 45% increase from $3,110,000 in 2021, with gross profit margin at 41% of revenues[276]. Capital and Financing Activities - The company raised gross proceeds of $4,750,000 from a private placement of preferred stock in November 2022[225]. - Net cash provided by financing activities was approximately $14,268,000 for the year ended December 31, 2022, compared to approximately $37,231,000 for the year ended December 31, 2021[297]. - The company recorded a deemed dividend of approximately $942,000 due to the issuance of Preferred Stock on November 29, 2022[288]. - The company plans to continue seeking additional debt and/or equity capital to fund future operations and acquisitions as necessary[292]. Operational Challenges and Risks - The company experienced supply chain constraints starting in December 2021, impacting inventory fulfillment for Viactiv products, resulting in approximately $83,000 in out-of-stock fees in 2022[234]. - The company utilized one manufacturer for 48% of its production and packaging in 2022, down from 70% in 2021, indicating a slight diversification in vendor reliance[249]. - As of December 31, 2022, one vendor accounted for 88% of total accounts payable, up from 46% in 2021, reflecting increased vendor concentration risk[250]. - The company recognized an impairment loss of $10,065,833 on intangible assets as of December 31, 2022, due to supply chain disruptions[281]. - Goodwill impairment of $11,893,134 was recorded for the year ended December 31, 2021, following a decrease in the company's share price[282]. Strategic Initiatives - The company added direct-to-consumer eCommerce capabilities on its website to expand sales channels for Viactiv products[217]. - The acquisition of Activ Nutritional has provided valuable attributes, including established distribution networks and experienced management[216]. - The company is exploring strategic alternatives to maximize stockholder value, including potential sales or mergers, with no set timetable for the review process[244][245]. - The company plans to explore strategic options, including potential mergers or acquisitions, to enhance growth and shareholder value[266]. - The company aims to strengthen its clinical nutrition strategy by advancing clinical evidence and increasing product awareness within the healthcare community[246]. Research and Development - Research and development costs rose by 201% to approximately $194,000 in 2022 from $64,000 in 2021, focusing on clinical studies for clinical nutrition products[277]. Stock and Compliance - A reverse stock split of 1-for-50 was approved on January 5, 2023, to regain compliance with Nasdaq's minimum bid requirement[222]. - The Series C Preferred Stock is convertible at a price of $0.15768 per share, adjusted to $7.884 post-reverse stock split[228]. - As of February 8, 2023, no shares of Preferred Stock were outstanding, and all investors were paid in full[233]. - The company intends to rely on certain exemptions under the JOBS Act as an "emerging growth company" until specific conditions are met[300].

Acquisition and Strategic Focus - The acquisition of Activ Nutritional, LLC on June 1, 2021, has materially changed the company's financial position and market profile, expanding opportunities for growth [113]. - The Company ceased operations of VectorVision in December 2021 to focus resources on growth-oriented brands like Viactiv [141]. - The Company is exploring strategic alternatives, including potential mergers or acquisitions, to enhance stockholder value and grow the business [127]. - The Company is exploring strategic acquisitions to capitalize on growth opportunities and enhance its business model [150]. Product Development and Sales Strategy - The company plans to focus on commercializing the Omega Boost Gel Bites and preparing for another product launch in 2023, with no new product launches planned for the remainder of 2022 [125]. - New product development, such as the Omega Boost Gel Bites, is a key component of the Company's sales growth strategy and aims to diversify the customer base [156]. - The company reported a 51% improvement in Omega-3 levels in just 4 weeks of customer usage for its new Viactiv Omega Boost Gel Bites product [117]. - Approximately 1% of sales revenue was derived from the newly launched direct-to-consumer e-commerce channel during the nine months ended September 30, 2022 [123]. - The Company intends to improve sales channels by enhancing product commercialization and has added direct-to-consumer eCommerce capabilities on viactiv.com [156]. Financial Performance and Challenges - Sales in the first nine months of 2022 were impacted by supply chain challenges, limiting inventory distribution, and overall sales declined during the three months ended September 30, 2022 [119]. - The Viactiv brand has a strong history of financial success, but sales have been adversely affected by general economic conditions impacting the broader vitamin, mineral, and supplement category [119]. - For the three months ended September 30, 2022, revenue was $2,663,550, a decrease of $485,062 or 15% compared to $3,148,612 in the same period of 2021 [158]. - Gross profit for the three months ended September 30, 2022 was $1,088,184, down $299,842 or 22% from $1,388,026 in 2021, with a gross margin of 40.9% compared to 44.08% in 2021 [160]. - Net loss for the three months ended September 30, 2022 was $1,696,112, a reduction of $1,318,724 or 44% from a net loss of $3,014,836 in the same period of 2021 [164]. - For the nine months ended September 30, 2022, revenue increased to $8,323,382, an increase of $3,717,754 or 81% compared to $4,605,628 in 2021 [166]. - Gross profit for the nine months ended September 30, 2022 was $3,584,185, an increase of $1,537,397 or 75% from $2,046,788 in 2021, with a gross margin of 43.1% compared to 44.4% in 2021 [168]. - Net loss for the nine months ended September 30, 2022 was $6,016,562, a decrease of $4,208,087 or 41% from a net loss of $10,224,649 in 2021 [172]. Cash Flow and Financing Activities - Cash on hand as of September 30, 2022 was approximately $12,946,000, with working capital of approximately $16,078,000 [173]. - The company closed a securities offering on February 23, 2022, generating net proceeds of approximately $9,969,000 [174]. - The gross proceeds from the February 2022 Offering were $11,100,000, with net proceeds of approximately $9,969,000 after deducting fees and expenses [135]. - Net cash provided by financing activities was $9,944,928 for the nine months ended September 30, 2022, primarily from the sale of common stock and warrant exercises [181]. - Net proceeds from the sale of common stock in financing activities were $8,834,899 for the nine months ended September 30, 2022 [181]. - Net cash provided by financing activities was $37,231,013 for the nine months ended September 30, 2021, with net proceeds from common stock sales at $33,662,597 [181]. - Warrant exercises resulted in net proceeds of $1,134,040 for the nine months ended September 30, 2022 [181]. - Warrant exercises in the previous year generated net proceeds of $3,568,414 [181]. Operational Challenges - The Company has been affected by supply chain constraints due to the COVID-19 pandemic, impacting inventory availability for Viactiv products [146]. - Significant broad-based inflation has increased manufacturing and distribution costs, with a price increase communicated to retail partners expected to be implemented by year-end 2022 [147]. - The company expects to continue incurring substantial losses and negative cash flow from operations for the foreseeable future [129]. - Research and development expenses for the three months ended September 30, 2022 increased by $43,969 or 271% to $60,203 compared to $16,234 in 2021 [162]. - Total operating expenses for the three months ended September 30, 2022 were $2,827,578, a decrease of $1,575,966 or 36% from $4,403,544 in 2021 [161]. Compliance and Regulatory Matters - The Company was granted a second 180-day compliance period by Nasdaq to regain compliance with the $1.00 minimum bid price requirement, expiring on January 23, 2023 [138]. - The results of operations for the nine months ended September 30, 2022, are not comparable to the same period in 2021 due to the acquisition of Activ [154].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number: 001-38861 GUARDION HEALTH SCIENCES, INC. (Exact name of registrant as specified in its charter) | Delaware | 47-4428421 | ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number: 001-38861 GUARDION HEALTH SCIENCES, INC. (Exact name of registrant as specified in its charter) | Delaware | 47-4428421 | ...