June 2025 We are the Optejet® Company An FDA-registered Class I Medical Device Forward-looking Statements Except for historical information, all the statements, expectations, and assumptions contained in this presentation are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions, or any other statements relating to our future activities or other future events or conditions, including esti ...

Financial Performance - Eyenovia reported a net loss of $3.5 million, or $1.59 per share, for Q1 2025, a significant improvement from a net loss of $10.9 million, or $18.75 per share, in Q1 2024[7]. - Total operating expenses for Q1 2025 were $3.0 million, representing a 70% decrease from $10.1 million in Q1 2024[8]. Expenses Management - Research and development expenses decreased by 85% to $0.7 million in Q1 2025, compared to $4.4 million in Q1 2024[7]. - General and administrative expenses were reduced by 35% to $2.4 million in Q1 2025, down from $3.6 million in Q1 2024[8]. - Eyenovia has reduced ongoing cash burn by approximately 70% compared to the previous year and has entered into a debt restructuring agreement deferring certain repayment obligations until October 2025[4][6]. Cash Position - As of March 31, 2025, Eyenovia's unrestricted cash and cash equivalents increased to $3.9 million from $2.1 million as of December 31, 2024[8]. - The total assets of Eyenovia as of March 31, 2025, were $5.98 million, compared to $3.67 million as of December 31, 2024[14]. Strategic Initiatives - The company is on track to file for U.S. regulatory approval for the Optejet user-filled device in September 2025, which could lead to multiple commercial opportunities[3][5]. - Eyenovia is negotiating a binding merger agreement with Betaliq, extending the exclusivity period until June 7, 2025, to finalize the agreement[2]. - The company aims to maximize shareholder value through the merger with Betaliq, which is expected to create a new eyecare company with immediate revenue from existing FDA-approved products[5].

Merger Negotiations - Eyenovia is in ongoing negotiations for a binding merger agreement with Betaliq, a clinical-stage pharmaceutical company focused on glaucoma [2] - The exclusivity period for the merger discussions has been extended until June 7, 2025, to facilitate the completion of the agreement [2] Optejet Development - The development of the Optejet user-filled device (UFD) is progressing well, with plans to file for U.S. regulatory approval in September 2025 [3] - Approval of the Optejet could lead to multiple commercial opportunities, both directly with consumers and through partnerships with eye care practitioners and license partners [3] Financial Performance - For Q1 2025, Eyenovia reported a net loss of $3.5 million, or $1.59 per share, a significant improvement from a net loss of $10.9 million, or $18.75 per share, in Q1 2024 [6][16] - Research and development expenses decreased by 85% to $0.7 million in Q1 2025, compared to $4.4 million in Q1 2024 [6] - General and administrative expenses were reduced by 35% to $2.4 million in Q1 2025, down from $3.6 million in Q1 2024 [7] - Total operating expenses for Q1 2025 were $3.0 million, a decrease of 70% from $10.1 million in Q1 2024 [7] Cash Position - As of March 31, 2025, the company's unrestricted cash and cash equivalents were $3.9 million, an increase from $2.1 million at the end of 2024 [7][14] - A debt restructuring agreement was entered into earlier this year, deferring certain repayment obligations until October 2025, which has contributed to extending the company's cash runway [4][5]

Revenue and Financial Performance - Revenue for Q1 2025 totaled $14,720, a significant increase from $4,993 in Q1 2024, with cost of revenues at $48 and $203,027 respectively[83] - The company reported a net loss of $3.5 million for Q1 2025, reduced from $9.9 million in Q1 2024[77] - The company reported net losses of $3.5 million for the three months ended March 31, 2025, compared to $10.9 million for the same period in 2024[91] - Other income (expense) for Q1 2025 was approximately $0.5 million of net other expense, a decrease from $0.7 million in Q1 2024[88] - Net cash used in operating activities was approximately $4.4 million for the three months ended March 31, 2025, a decrease from $9.9 million in the same period of 2024[93] - Net cash provided by financing activities totaled approximately $6.3 million for the three months ended March 31, 2025, compared to $3.1 million in the same period of 2024[95] Expenses and Cost Management - Research and development expenses decreased by 85% to $0.7 million in Q1 2025 from $4.4 million in Q1 2024, primarily due to layoffs and the wind down of clinical trials[84] - General and administrative expenses for Q1 2025 were $2.4 million, down 35% from $3.6 million in Q1 2024, reflecting cost-cutting measures[86] Financial Position and Compliance - As of March 31, 2025, the company had an accumulated deficit of approximately $198.8 million[77] - The working capital deficit improved to $9.9 million as of March 31, 2025, from $13.3 million as of December 31, 2024[89] - The company has commitments to pay $5.1 million for accounts payable and $10.8 million for notes payable within the next twelve months[96] - The accumulated deficit as of March 31, 2025, was approximately $198.8 million[91] - The company faces substantial doubt about its ability to continue as a going concern for at least one year from the date of the financial statements[92] - The company intends to submit a plan to regain compliance with Nasdaq's minimum equity requirement of $2,500,000 by June 13, 2025[76] - The company regained compliance with Nasdaq's minimum bid price requirement of $1.00 per share after a reverse stock split on January 31, 2025[75] Strategic Initiatives - The company entered into a non-binding letter of intent for a proposed business combination with Betaliq, a clinical stage pharmaceutical company focused on glaucoma[71] - The company plans to submit its Optejet user-filled device for regulatory approval in the U.S. in the second half of 2025[70] Market and Operational Risks - The ongoing "Tariff War" could adversely affect the company's supply chain and product demand, impacting financial performance[97] - The company has no off-balance sheet arrangements that could materially affect its financial conditions[100]

Financial Position and Performance - As of December 31, 2024, the company had cash and cash equivalents of $2.1 million and an accumulated deficit of approximately $195.3 million[250]. - The company incurred net losses of approximately $49.8 million and $27.3 million for the years ended December 31, 2024 and 2023, respectively[271]. - The company owed $10.2 million in principal and accrued interest under the Loan and Security Agreement as of March 15, 2025[250]. - The company has federal net operating loss carry-forwards of approximately $133.7 million as of December 31, 2024[272]. - The company expects to continue incurring cash outflows from operations for the near future, raising substantial doubt about its ability to continue as a going concern[250]. - The company may need to raise additional capital to remain a going concern, which may not be available on acceptable terms[252]. - Eyenovia recorded net sales of $57,336 for the year ended December 31, 2024, primarily from Mydcombi and clobetasol propionate[285]. Business Strategy and Operations - The company is exploring strategic paths, including partnerships and acquisitions, to maximize stockholder value[253]. - The proposed business combination with Betaliq is anticipated to close in the second quarter of 2025, but no assurance can be given regarding the completion or terms of the agreement[276]. - Eyenovia expects to incur substantial non-recurring expenses related to the proposed business combination, including legal and financial advisory fees[283]. - Eyenovia requires significant additional funding to advance the manufacturing and commercialization of Mydcombi and develop the Gen-2 Optejet[286]. Market and Competition - The commercial success of Mydcombi and clobetasol propionate is critical for Eyenovia's profitability, and their market acceptance is uncertain[291]. - The company faces competition in a rapidly changing specialty pharma market, which may affect its ability to commercialize products[293]. - Eyenovia's ability to achieve profitability is highly dependent on the successful commercialization of its currently approved products[285]. - The company may encounter challenges in convincing the medical community and third-party payors to accept and use its products[292]. Regulatory and Compliance Risks - Regulatory compliance is critical, as failure to adapt to changes in requirements could result in loss of marketing approval and negatively affect profitability[316]. - The company has obtained FDA approval for Mydcombi in the U.S., but may face challenges in obtaining approval in other jurisdictions, limiting market potential[317]. - The company must comply with strict advertising and promotion regulations, and failure to do so could result in significant penalties and harm to its reputation[322]. - The company is subject to various healthcare laws and regulations, including the federal Anti-Kickback Statute and the False Claims Act, which may impact business practices and financial arrangements[330]. - Legislative reforms, such as the Patient Protection and Affordable Care Act (ACA) and the Inflation Reduction Act of 2022, could materially affect the company's financial condition and operational results[334][337]. Intellectual Property and Legal Risks - The company’s success heavily relies on protecting its intellectual property; inadequate protection could allow competitors to erode its competitive advantage[373]. - The patent application process is complex and costly, with no assurance that all necessary patents will be obtained or enforced effectively[382]. - The company may face challenges in maintaining patent rights due to procedural non-compliance, which could lead to loss of patent protection[389]. - The company may face high costs and resource diversion from enforcing patent rights in foreign jurisdictions, where intellectual property laws may be less favorable[400]. Human Resources and Management - The company had 14 total employees as of March 15, 2025, with 13 being full-time and one part-time, relying on third-party contractors for professional services[353]. - The company is highly dependent on its senior management team, including the Chief Executive Officer, and any loss of these key personnel could impede research, development, and commercialization objectives[350]. - The company faces intense competition for qualified personnel among biotechnology and pharmaceutical companies, which may hinder its ability to retain and motivate high-quality staff[352]. Manufacturing and Supply Chain Risks - The company does not currently have agreements with third-party suppliers for the long-term commercial supply of components for Mydcombi, which may delay commercialization activities[362]. - Manufacturing processes for Mydcombi are complicated and expensive, requiring months of advance planning, and reliance on a limited number of manufacturers increases risks[364]. - The company may encounter delays in the manufacturing of the second generation Optejet device due to reliance on third parties, potentially impairing commercialization efforts[361]. - Any disruption at third-party suppliers, such as natural hazards or vandalism, could significantly interrupt manufacturing capability, risking financial stability[367]. Financial Reporting and Governance - The company is subject to the reporting requirements of the Sarbanes-Oxley Act, which increases legal, accounting, and compliance costs[424]. - Material weaknesses have been identified in the company's internal control over financial reporting, raising concerns about the accuracy and reliability of financial statements[437]. - The company is taking steps to remediate identified material weaknesses, but there is no assurance that these measures will be sufficient to prevent future weaknesses[438]. - Provisions in the company's corporate charter may discourage or prevent favorable mergers or acquisitions, potentially depressing the market price of its common stock[431].

Core Insights - Eyenovia, Inc. is advancing its Optejet UFD, a user-filled device designed for various topical ophthalmic liquids, targeting multiple billion-dollar markets [1][2] - The company has completed significant Verification & Validation studies to ensure the device meets customer requirements and is on track for a 510(k) submission by September [2] - The Optejet UFD aims to enhance user experience by allowing consumers to obtain twice as many uses from their current eyedrops [2] Company Overview - Eyenovia, Inc. specializes in ophthalmic technology, focusing on developing and commercializing advanced products using its proprietary Optejet platform [3] - The current commercial portfolio includes clobetasol propionate ophthalmic suspension for post-surgical pain and inflammation, and Mydcombi® for mydriasis [3] Product Development - The Optejet UFD has undergone extensive testing, including usability, dosing performance, and safety testing, demonstrating its capability to dispense ophthalmic solutions accurately and reliably [5][6] - Key components of the device have been tested over 30,000 times, confirming its durability and performance standards [5] Market Potential - The combination of the Optejet UFD with artificial tears or lens rewetting solutions is expected to significantly improve treatment options and outcomes for patients [2][3]

Business Combination - Eyenovia entered into a non-binding letter of intent for a proposed business combination with Betaliq, a clinical stage pharmaceutical company focused on Glaucoma [4]. - The proposed transaction is structured as a reverse merger, with Betaliq becoming a wholly-owned subsidiary of Eyenovia [5]. - Betaliq stockholders are expected to receive approximately 83.7% of the equity of the combined company, while Eyenovia stockholders would own approximately 16.3% [9]. - The valuation for Betaliq is approximately $77 million, while Eyenovia is valued at approximately $15 million [9]. - The completion of the business combination is subject to satisfactory due diligence, board approvals, and other customary closing conditions [12]. - The exclusivity period for negotiations ends on May 16, 2025, but may be extended [11]. - If the business combination is not completed, Eyenovia may need to evaluate other strategic alternatives, which could negatively impact stockholders [19]. - Forward-looking statements indicate uncertainties regarding the completion of the business combination and its potential benefits [24]. Financial Position - As of December 31, 2024, Eyenovia had approximately $2.1 million in cash [14]. - Eyenovia anticipates incurring substantial transaction costs related to the business combination, including legal and advisory fees [22].

Core Viewpoint - The proposed reverse merger between Eyenovia, Inc. and Betaliq, Inc. aims to create a new publicly-listed ophthalmic company that combines innovative technologies for glaucoma treatment, potentially enhancing the administration of topical eye medications [1][2][7]. Company Overview - Eyenovia, Inc. specializes in developing advanced ophthalmic products using its proprietary Optejet dispensing platform, which is designed to improve patient compliance and treatment outcomes [10]. - Betaliq, Inc. focuses on developing topical glaucoma treatments utilizing its EyeSol water-free drug delivery technology, which enhances bioavailability and reduces the need for preservatives [9]. Merger Details - The merger values Betaliq at approximately $77 million and Eyenovia at about $15 million, with Betaliq equity holders expected to own around 83.7% of the combined entity [4]. - The transaction is contingent upon satisfactory due diligence, definitive agreements, board approvals, and necessary financing [3]. Technology Synergy - The merger combines Betaliq's EyeSol technology, which offers a drop size of 10 microliters and increased bioavailability, with Eyenovia's Optejet platform, which enhances usability and compliance [5]. - Both technologies are FDA-approved and are expected to create innovative treatment options for glaucoma and other ocular diseases [2][7]. Future Developments - Eyenovia is on track to file for U.S. regulatory approval for its user-filled Optejet in the fourth quarter of this year, which is compatible with various topical ophthalmic liquids [6]. - The combined company aims to leverage existing product pipelines and partnerships to expand its market presence in the eyecare sector [7].

Core Viewpoint - Eyenovia, Inc. has regained compliance with Nasdaq listing requirements, marking a significant milestone in its efforts to enhance shareholder value and advance the development of its Optejet device [1][2]. Company Overview - Eyenovia, Inc. is focused on developing its proprietary Optejet topical ophthalmic medication dispensing platform, which aims to improve treatment options for chronic front-of-the-eye diseases through enhanced safety, tolerability, and compliance compared to standard eye drops [3]. Strategic Actions - The company has taken steps to restructure and accelerate the development of the Optejet, including a reverse stock split approved by shareholders, which facilitated compliance with Nasdaq's continued listing requirements [2].

Core Viewpoint - Eyenovia, Inc. has amended its senior secured convertible debt to defer interest and principal payments until September 2025, enhancing its financial flexibility and liquidity for the development of its Optejet device [1][2]. Financial Flexibility - The Amendment allows Eyenovia to defer monthly interest and amortization payments from March 2025 through September 2025, reducing immediate cash needs [1]. - Full conversion of the debt into common shares will commence on April 1, 2025, at a conversion price of $1.68 per share [1]. Strategic Development - The Amendment is expected to strengthen Eyenovia's capital structure and improve liquidity, facilitating the development of the Optejet device towards a potential regulatory filing [2]. - The CEO expressed appreciation for the lender's confidence and indicated ongoing discussions with multiple parties to maximize shareholder value [2]. Company Overview - Eyenovia, Inc. specializes in ophthalmic technology, focusing on the Optejet topical ophthalmic medication dispensing platform, which aims to improve treatment options for chronic front-of-the-eye diseases [5].