HYPERION DEFI, INC. 10-Q

Item 1. Financial Statements. EYENOVIA, INC. Condensed Balance Sheets ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, December 31, ​ 2024 2023 ​ (unaudited) ​ ​ ​ Assets ​ ​ ​ ​ ​ Current Assets ​ ​ Cash and cash equivalents ​ $ 7,188,129 ​ $ 14,849,057 Inventories ​ ​ 2,967,256 ​ ​ 109,798 Deferred clinical supply costs ​ ​ 408,832 ​ ​ 4,256,793 License fee and expense reimbursements receivable ​ ​ 137,594 ​ ​ 123,833 Security deposits, current ​ ​ — ​ ​ 1,506 Prepaid expenses and other current assets ​ 987,754 ​ 1,365,731 Total Current Assets ​ 11,689,565 ​ 20,706,718 ​ ​ ​ ​ ​ ​ ​ Property and equipment, net ​ 2,752,404 ​ 3,374,384 Security deposits, non-current ​ 197,526 ​ 197,168 Intangible assets ​ ​ 6,122,945 ​ ​ 2,122,945 Prepaid expenses, non-current ​ ​ 46,520 ​ ​ - Operating lease right-of-use asset ​ ​ 1,275,690 ​ ​ 1,666,718 Equipment deposits ​ 711,441 ​ 711,441 Total Assets ​ $ 22,796,091 ​ $ 28,779,374 ​ ​ ​ ​ Liabilities and Stockholders’ Equity ​ ​ ​ ​ ​ ​ ​ Current Liabilities: ​ ​ ​ Accounts payable ​ $ 1,573,940 ​ $ 1,753,172 Accrued compensation ​ 1,656,832 ​ 1,658,613 Accrued expenses and other current liabilities ​ 2,518,086 ​ 287,928 Operating lease liabilities - current portion ​ ​ 604,647 ​ ​ 501,250 Notes payable - current portion, net of debt discount of $ 562,711 and $ 503,914 as of September 30, 2024 and December 31, 2023, respectively ​ ​ 6,168,593 ​ ​ 5,329,419 Convertible notes payable - current portion, net of debt discount of $ 72,467 and $ 0 as of September 30, 2024 and December 31, 2023, respectively ​ ​ 3,260,866 ​ ​ — Total Current Liabilities ​ ​ 15,782,964 ​ ​ 9,530,382 ​ ​ ​ ​ ​ ​ ​ Accrued expenses and other non-current liabilities ​ ​ 316,275 ​ ​ — Operating lease liabilities - non-current portion ​ ​ 836,434 ​ ​ 1,292,667 Notes payable - non-current portion, net of debt discount of $ 0 and $ 448,367 as of September 30, 2024 and December 31, 2023, respectively ​ ​ 637,500 ​ ​ 4,355,800 Convertible notes payable - non-current portion, net of debt discount of $ 163,051 and $ 398,569 as of September 30, 2024 and December 31, 2023, respectively ​ 1,503,615 ​ 4,601,431 Total Liabilities ​ ​ 19,076,788 ​ ​ 19,780,280 ​ ​ ​ ​ ​ ​ ​ Commitments and contingencies (Note 8) ​ ​ ​ ​ ​ Stockholders’ Equity: ​ ​ Preferred stock, $ 0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2024 and December 31, 2023 ​ — ​ — Common stock, $ 0.0001 par value, 300,000,000 shares authorized; 86,375,958 and 45,553,026 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively ​ 8,638 ​ 4,555 Additional paid-in capital ​ 179,065,877 ​ 154,486,098 Accumulated deficit ​ ( 175,355,212 ) ​ ( 145,491,559 ) Total Stockholders’ Equity ​ ​ 3,719,303 ​ ​ 8,999,094 Total Liabilities and Stockholders’ Equity ​ $ 22,796,091 ​ $ 28,779,374 ​ The accompanying notes are an integral part of these condensed financial statements. ​ 2 Table of Contents EYENOVIA, INC. Condensed Statements of Operations (unaudited) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Three Months Ended ​ For the Nine Months Ended ​ ​ September 30, ​ September 30, ​ 2024 2023 2024 2023 Operating Income ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Revenue ​ $ 1,625 ​ $ 1,198 ​ $ 29,243 ​ $ 1,198 Cost of revenue ​ ​ ( 132,522 ) ​ ​ ( 13,416 ) ​ ​ ( 825,910 ) ​ ​ ( 13,416 ) Gross Loss ​ ​ ( 130,897 ) ​ ​ ( 12,218 ) ​ ​ ( 796,667 ) ​ ​ ( 12,218 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Operating Expenses: ​ ​ ​ ​ ​ ​ ​ ​ ​ Research and development ​ ​ 3,471,939 ​ ​ 3,578,113 ​ ​ 12,500,713 ​ ​ 8,911,124 Selling, general and administrative ​ 3,729,091 ​ 2,929,855 ​ ​ 11,125,115 ​ ​ 9,016,550 Reacquisition of license rights ​ ​ — ​ ​ — ​ ​ 4,864,600 ​ ​ — Total Operating Expenses ​ 7,201,030 ​ 6,507,968 ​ ​ 28,490,428 ​ ​ 17,927,674 Loss From Operations ​ ( 7,331,927 ) ​ ( 6,520,186 ) ​ ​ ( 29,287,095 ) ​ ​ ( 17,939,892 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Other Income (Expense): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Other income (expense), net ​ ​ 1,184 ​ ​ ( 348,226 ) ​ ​ ( 93,394 ) ​ ​ ( 157,783 ) Change in fair value of equity consideration payable ​ ​ — ​ ​ — ​ ​ 1,240,800 ​ ​ — Interest expense ​ ​ ( 602,109 ) ​ ( 679,222 ) ​ ​ ( 1,954,768 ) ​ ​ ( 1,691,228 ) Interest income ​ 44,999 ​ 208,901 ​ ​ 230,804 ​ ​ 494,944 Total Other Expense ​ ( 555,926 ) ​ ( 818,547 ) ​ ​ ( 576,558 ) ​ ​ ( 1,354,067 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Net Loss ​ $ ( 7,887,853 ) ​ $ ( 7,338,733 ) ​ $ ( 29,863,653 ) ​ $ ( 19,293,959 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Net Loss Per Share - Basic and Diluted ​ $ ( 0.11 ) ​ $ ( 0.18 ) ​ $ ( 0.53 ) ​ $ ( 0.50 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ Shares Outstanding - Basic and Diluted ​ 69,558,325 ​ 40,139,697 ​ ​ 56,476,876 ​ ​ 38,563,074 ​ The accompanying notes are an integral part of these condensed financial statements. ​ 3 Table of Contents EYENOVIA, INC. Condensed Statements of Changes in Stockholders’ (Deficiency) Equity (unaudited) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Three and Nine Months Ended September 30, 2024 ​ ​ ​ ​ ​ ​ ​ Additional ​ ​ ​ ​ Total ​ ​ Common Stock ​ Paid-In ​ Accumulated ​ Stockholders’ ​ Shares Amount Capital Deficit (Deficiency) Equity Balance - January 1, 2024 45,553,026 ​ $ 4,555 ​ $ 154,486,098 ​ $ ( 145,491,559 ) ​ $ 8,999,094 Issuance of common stock in At the Market Program [1] 1,833,323 ​ 183 ​ 3,194,364 ​ — ​ 3,194,547 Stock-based compensation — ​ — ​ 546,232 ​ — ​ 546,232 Net loss — ​ — ​ — ​ ( 10,922,101 ) ​ ( 10,922,101 ) Balance - March 31, 2024 47,386,349 ​ 4,738 ​ 158,226,694 ​ ( 156,413,660 ) ​ 1,817,772 Issuance of common stock in offering [2] ​ 3,223,726 ​ ​ 322 ​ ​ 1,888,507 ​ ​ — ​ ​ 1,888,829 Issuance of common stock as consideration for licensing agreement [3] 613,496 ​ 62 ​ 436,747 ​ — ​ 436,809 Issuance of common stock as consideration for reacquisition of licensing agreement [4] 2,299,397 ​ 230 ​ 2,322,161 ​ — ​ 2,322,391 Issuance of common stock in At the Market Program [5] 2,294,953 ​ 230 ​ 1,676,709 ​ — ​ 1,676,939 Stock-based compensation ​ — ​ ​ — ​ ​ 541,056 ​ ​ — ​ ​ 541,056 Net loss ​ — ​ ​ — ​ ​ — ​ ​ ( 11,053,699 ) ​ ​ ( 11,053,699 ) Balance - June 30, 2024 ​ 55,817,921 ​ ​ 5,582 ​ ​ 165,091,874 ​ ​ ( 167,467,359 ) ​ ​ ( 2,369,903 ) Issuance of common stock and warrants in offerings [6] ​ 29,055,757 ​ ​ 2,906 ​ ​ 12,345,272 ​ ​ — ​ ​ 12,348,178 Warrant modification and additional warrants - incremental value (7) ​ — ​ ​ — ​ ​ 2,868,000 ​ ​ — ​ ​ 2,868,000 Warrant modification and additional warrants - in issuance costs for offering (8) ​ — ​ ​ — ​ ​ ( 2,868,000 ) ​ ​ — ​ ​ ( 2,868,000 ) Issuance of common stock in At the Market Program [9] ​ 1,502,280 ​ ​ 150 ​ ​ 1,175,733 ​ ​ — ​ ​ 1,175,883 Stock-based compensation ​ — ​ ​ — ​ ​ 452,998 ​ ​ — ​ ​ 452,998 Net loss ​ — ​ ​ — ​ ​ — ​ ​ ( 7,887,853 ) ​ ​ ( 7,887,853 ) Balance - September 30, 2024 ​ 86,375,958 ​ $ 8,638 ​ $ 179,065,877 ​ $ ( 175,355,212 ) ​ $ 3,719,303 [1] Includes gross proceeds of $ 3,293,347 less total issuance costs of $ 98,800 . [2] Includes gross proceeds of $ 2,000,000 , less total issuance costs of $ 111,171 . [3] Shares issued as partial consideration for License Agreement with Formosa Pharmaceuticals Inc. [4] Shares issued as partial consideration for reversion of License Agreement with Bausch & Lomb Ireland Limited. [5] Includes gross proceeds of $ 1,728,804 less total issuance costs of $ 51,865 . [6] Includes gross proceeds of $ 14,139,994 , less total cash issuance costs of $ 1,791,816 . [7] Offering includes modification of warrants and additional warrants in the July 2024 offering. [8] Non-cash warrant modification and additional warrants issuance costs related to one of the offerings of $ 2,868,000 are shown on a separate line item. [9] Includes gross proceeds of $ 1,212,251 less total issuance costs of $ 36,368 . ​ The accompanying notes are an integral part of these condensed financial statements. 4 Table of Contents EYENOVIA, INC. Condensed Statements of Changes in Stockholders’ Equity, continued (unaudited) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Three and Nine Months Ended September 30, 2023 ​ ​ ​ ​ ​ ​ ​ Additional ​ ​ ​ ​ Total ​ ​ Common Stock ​ Paid-In ​ Accumulated ​ Stockholders’ ​ Shares Amount Capital Deficit Equity Balance - January 1, 2023 ​ 36,668,980 ​ $ 3,667 ​ $ 135,461,361 ​ $ ( 118,230,463 ) ​ $ 17,234,565 Issuance of common stock in At the Market offering [1] ​ 1,299,947 ​ ​ 130 ​ ​ 3,499,462 ​ ​ — ​ ​ 3,499,592 Cashless exercise of stock options ​ 19,530 ​ ​ 2 ​ ​ ( 2 ) ​ ​ — ​ ​ — Stock-based compensation ​ — ​ ​ — ​ ​ 819,064 ​ ​ — ​ ​ 819,064 Issuance of common stock related to vested restricted stock units ​ 3,289 ​ ​ — ​ ​ — ​ ​ — ​ ​ — Net loss ​ — ​ ​ — ​ ​ — ​ ​ ( 5,739,366 ) ​ ​ ( 5,739,366 ) Balance - March 31, 2023 ​ 37,991,746 ​ ​ 3,799 ​ ​ 139,779,885 ​ ​ ( 123,969,829 ) ​ ​ 15,813,855 Issuance of common stock in At the Market offering [2] ​ 121,989 ​ ​ 13 ​ ​ 403,107 ​ ​ — ​ ​ 403,120 Cashless exercise of stock options ​ 1,219 ​ ​ — ​ ​ — ​ ​ — ​ ​ — Exercise of stock options ​ 10,000 ​ ​ 1 ​ ​ 27,199 ​ ​ — ​ ​ 27,200 Stock-based compensation ​ — ​ ​ — ​ ​ 493,632 ​ ​ — ​ ​ 493,632 Issuance of common stock related to vested restricted stock units ​ 44,444 ​ ​ 4 ​ ​ ( 4 ) ​ ​ — ​ ​ — Net loss ​ — ​ ​ — ​ ​ — ​ ​ ( 6,215,860 ) ​ ​ ( 6,215,860 ) Balance -June 30, 2023 ​ 38,169,398 ​ ​ 3,817 ​ ​ 140,703,819 ​ ​ ( 130,185,689 ) ​ ​ 10,521,947 Issuance of common stock and warrants in registered direct offering [3][7] ​ 4,198,633 ​ ​ 420 ​ ​ 10,885,694 ​ ​ — ​ ​ 10,886,114 Issuance of common stock as consideration for licensing agreement [4] ​ 487,805 ​ ​ 49 ​ ​ 999,951 ​ ​ — ​ ​ 1,000,000 Issuance of common stock in At the Market offering [5] ​ 42,410 ​ ​ 4 ​ ​ 97,432 ​ ​ — ​ ​ 97,436 Warrant modification - incremental value (6) ​ — ​ ​ — ​ ​ 1,738,700 ​ ​ — ​ ​ 1,738,700 Warrant modification - in issuance costs for registered direct offering (7) ​ — ​ ​ — ​ ​ ( 1,738,700 ) ​ ​ — ​ ​ ( 1,738,700 ) Stock-based compensation ​ — ​ ​ — ​ ​ 612,969 ​ ​ — ​ ​ 612,969 Net loss ​ — ​ ​ — ​ ​ — ​ ​ ( 7,338,733 ) ​ ​ ( 7,338,733 ) Balance - September 30, 2023 ​ 42,898,246 ​ $ 4,290 ​ $ 153,299,865 ​ $ ( 137,524,422 ) ​ $ 15,779,733 [1] Includes gross proceeds of $ 3,607,827 less total issuance costs of $ 108,235 . [2] Includes gross proceeds of $ 415,588 less total issuance costs of $ 12,468 . [3] Includes gross proceeds of $ 11,977,468 less total cash issuance costs of $ 1,091,354 . [4] Shares issued as partial consideration for License Agreement with Formosa Pharmaceuticals Inc. [5] Includes gross proceeds of $ 100,449 less total issuance costs of $ 3,013 . [6] Registered direct offering included modification of warrant originally granted in the March 2022 offering. [7] Non-cash warrant modification issuance costs related to the registered direct offering of $ 1,738,700 are shown on a separate line item. ​ The accompanying notes are an integral part of these condensed financial statements. ​ 5 Table of Contents EYENOVIA, INC. Condensed Statements of Cash Flows (unaudited) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Nine Months Ended ​ ​ September 30, ​ 2024 2023 Cash Flows From Operating Activities ​ ​ Net loss ​ $ ( 29,863,653 ) ​ $ ( 19,293,959 ) Adjustments to reconcile net loss to net cash used in operating activities: ​ ​ ​ ​ Stock-based compensation ​ ​ 1,540,286 ​ ​ 1,925,665 Change in fair value of equity consideration payable ​ ​ ( 1,240,800 ) ​ ​ — Depreciation of property and equipment ​ 830,605 ​ 505,684 Amortization of debt discount ​ ​ 552,620 ​ ​ 497,654 Write-off of property and equipment ​ ​ 88,251 ​ ​ — Write-down of inventories to net realizable value ​ ​ 769,217 ​ ​ 12,218 Provision for returned deferred clinical supplies ​ ​ — ​ ​ 400,000 Reacquisition of license rights ​ 2,864,600 ​ — Non-cash rent expense ​ 391,028 ​ 403,362 Changes in operating assets and liabilities: ​ ​ ​ ​ Prepaid expenses and other current assets ​ ​ 836,507 ​ ​ 39,035 License fee and expense reimbursement receivables ​ ​ ( 13,761 ) ​ ​ 786,772 Deferred clinical supply costs ​ ​ 1,272,309 ​ ​ ( 1,637,756 ) Inventories ​ ​ ( 1,051,023 ) ​ ​ ( 62,514 ) Security and equipment deposits ​ ​ 1,148 ​ 1,750 Accounts payable ​ ( 179,232 ) ​ ( 2,255 ) Accrued compensation ​ ( 1,781 ) ​ ( 371,359 ) Accrued expenses and other current liabilities ​ ( 453,567 ) ​ ​ ( 307,373 ) Lease liabilities ​ ​ ( 352,836 ) ​ ​ ( 411,266 ) Net Cash Used In Operating Activities ​ ( 24,010,082 ) ​ ​ ( 17,514,342 ) ​ ​ ​ ​ ​ ​ Cash Flows From Investing Activities ​ ​ ​ ​ ​ ​ Purchases of property and equipment ​ ​ ( 161,476 ) ​ ​ ( 2,702,361 ) Investment in intangible asset ​ ​ — ​ ​ ( 1,122,945 ) Net Cash Used In Investing Activities ​ ​ ( 161,476 ) ​ ​ ( 3,825,306 ) ​ ​ ​ ​ ​ ​ ​ Cash Flows From Financing Activities ​ ​ ​ ​ Proceeds from sale of common stock and warrants in offerings ​ 16,139,994 ​ 11,977,468 Payment of offerings issuance costs ​ ​ ( 1,902,987 ) ​ ​ ( 1,091,354 ) Proceeds from sale of common stock in At the Market Program ​ 6,234,402 ​ 4,123,864 Payment of issuance costs for At the Market Program ​ ​ ( 187,033 ) ​ ​ ( 123,716 ) Proceeds from exercise of stock options ​ ​ — ​ ​ 27,200 Proceeds from note payable to Avenue ​ ​ — ​ ​ 5,000,000 Payment of issuance costs for notes issued to Avenue ​ ​ — ​ ​ ( 125,982 ) Repayments of notes payable ​ ( 3,773,746 ) ​ ( 609,140 ) Net Cash Provided By Financing Activities ​ 16,510,630 ​ 19,178,340 Net Decrease in Cash and Cash Equivalents ​ ( 7,660,928 ) ​ ( 2,161,308 ) Cash and Cash Equivalents - Beginning of Period ​ ​ 14,849,057 ​ 22,863,520 Cash and Cash Equivalents - End of Period ​ $ 7,188,129 ​ $ 20,702,212 ​ The accompanying notes are an integral part of these condensed financial statements. 6 Table of Contents EYENOVIA, INC. Condensed Statements of Cash Flows, continued (unaudited) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Nine Months Ended ​ ​ September 30, ​ 2024 2023 Supplemental Disclosure of Cash Flow Information: ​ ​ ​ ​ Cash paid during the period for: ​ ​ ​ ​ ​ ​ Interest ​ $ 1,402,147 ​ $ 1,194,132 ​ ​ ​ ​ ​ ​ ​ Supplemental Disclosure of Non-Cash Investing and Financing Activities ​ ​ ​ ​ ​ ​ Purchase of insurance policy financed by note payable ​ $ 505,050 ​ $ 609,140 Accrual for intangible asset milestone obligation ​ $ 2,000,000 ​ $ — Reclassification of deferred clinical supply costs to inventories ​ $ 2,575,652 ​ $ — Right-of-use assets obtained in exchange for lease liabilities ​ $ — ​ $ 904,437 Vendor deposits applied to purchases of property and equipment ​ $ — ​ $ 39,573 Original issue discount on notes payable ​ $ — ​ $ 212,500 Warrant modification and additional warrants - incremental value ​ $ 2,868,000 ​ $ 1,738,700 Issuance of common stock in consideration of licensing agreement ​ $ — ​ $ 1,000,000 Cashless exercise of stock options ​ $ — ​ $ 2 Common stock issued in consideration for licensing agreement ​ $ 436,809 ​ $ — Common stock issued in consideration for reacquisition of licensing agreement ​ $ 2,322,391 ​ $ — Issuance of common stock related to vested restricted stock units ​ $ — ​ $ 4 ​ The accompanying notes are an integral part of these condensed financial statements. ​ ​ 7 Table of Contents EYENOVIA, INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED) Note 1 – Business Organization, Nature of Operations and Basis of Presentation Eyenovia, Inc. (“Eyenovia” or the “Company”) is an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform. The Optejet is especially useful in the treatment of chronic front-of-the-eye diseases due to its ease of use, enhanced safety and tolerability, and potential for superior compliance versus standard eye drops. Together, these benefits may combine to produce better treatment options and outcomes for patients and providers. The company’s pre-NDA candidate, MicroPine, is being developed for pediatric progressive myopia, a global epidemic impacting hundreds of millions of children worldwide and representing a multi-billion-dollar addressable market. The company’s current commercial portfolio includes clobetasol propionate ophthalmic suspension, 0.05%, for post-surgical pain and inflammation, and Mydcombi® for mydriasis. Eyenovia has also secured licensing and development agreements for additional multi-billion-dollar indications where the Optejet may be advantageous, including dry eye. The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the condensed financial statements of the Company as of September 30, 2024 and for the three and nine months ended September 30, 2024 and 2023. The results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the operating results for the full year ending December 31, 2024 or any other period. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and related disclosures of the Company as of December 31, 2023 and for the year then ended, which were included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 18, 2024 (the “2023 Form 10-K”), as amended by Amendment No. 1, filed with the SEC on April 26, 2024 (the “2023 Form 10-K Amendment”). ​ Note 2 – Summary of Significant Accounting Policies The Company disclosed its significant accounting policies in Note 2 – Summary of Significant Accounting Policies included in the 2023 Form 10-K. There have been no material changes to the Company’s significant accounting policies during the nine months ended September 30, 2024, except as disclosed below. Liquidity and Going Concern As of September 30, 2024, the Company had unrestricted cash and cash equivalents of approximately $ 7.2 million and an accumulated deficit of approximately $ 175.4 million. For the nine months ended September 30, 2024 and 2023, the Company incurred net losses of approximately $ 29.9 million and $ 19.3 million, respectively, and used cash in operations of approximately $ 24.0 million and $ 17.5 million, respectively. The Company does not have recurring significant revenue and has not yet achieved profitability. The Company expects to continue to incur cash outflows from operations for the near future. The Company expects that it will continue to incur significant research and development and selling, general and administrative expenses and, as a result, it will eventually need to generate significant product revenues to achieve profitability. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern for at least one year from the date that these financial statements are issued. Implementation of the Company’s plans and its ability to continue as a going concern will depend on many factors, including the Company’s ability to successfully commercialize its products and services, competing technological and market developments, and the need to enter into collaborations with other companies, or acquire other companies or technologies to enhance or complement its product and service offerings. Additionally, the Company will need to raise further capital, through the sale of additional equity or debt securities. If the Company is unable to generate sufficient recurring revenues or secure additional capital, it may be required to curtail its research and development initiatives and take additional measures to reduce costs in order to conserve its cash. ​ Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents in the financial statements. As of September 30, 2024 and December 31, 2023, the Company had Treasury bills with original maturity dates of three months or less in the amounts of $ 0 and $ 5,450,118 , respectively. 8 Table of Contents EYENOVIA, INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED) The Company has cash deposits in financial institutions that, at times, may be in excess of Federal Deposit Insurance Corporation (“FDIC”) insurance limits. The Company has not experienced losses in such accounts and periodically evaluates the creditworthiness of its financial institutions. As of September 30, 2024 and December 31, 2023, the Company had cash and cash equivalent balances in excess of FDIC insurance limits of $ 6,784,903 and $ 14,243,870 , respectively. Clinical Supply Arrangements Bausch + Lomb Ireland Limited (“Bausch + Lomb”) and Arctic Vision had contracted with the Company to manufacture and supply them with the appropriate drug-device combination products to conduct their clinical trials on a cost plus 10 % mark-up basis. Pursuant to the Letter Agreement (as defined below) with Bausch + Lomb, as referenced in Note 8 – Commitments and Contingencies – Bausch License Agreements, the arrangement with Bausch + Lomb has been terminated, and all rights have been repurchased by Eyenovia. The arrangement with Arctic Vision is still in place. The Company’s licensing agreement with Arctic Vision represents a collaborative arrangement and Arctic Vision is not a customer with respect to the clinical supply arrangements. The Company’s policy is to (a) defer the materials and manufacturing costs in order to properly match them up against the income from the clinical supply arrangements; and (b) report the net income from the clinical supply arrangements as other income. Deferred clinical supply costs were $ 0.4 million and $ 4.3 million at September 30, 2024 and December 31, 2023, respectively. See Note 8 – Commitments and Contingencies –Defective Clinical Supply for additional information. Inventories Inventories are stated at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method. The cost of inventory that is sold commercially to third parties is included within cost of sales. The Company will periodically review for slow-moving, excess or obsolete inventories. Inventory is primarily comprised of drug-device combination products, which are available for commercial sale, as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, December 31, ​ 2024 ​ 2023 Finished goods ​ $ 427,217 ​ $ 30,683 Raw materials ​ 2,540,039 ​ 79,115 Total inventory ​ $ 2,967,256 ​ $ 109,798 ​ The Company has evaluated the net realizable value of the commercial inventory. The write-down of commercial inventory to net realizable value for the three months ended September 30, 2024 and 2023 was $ 0.1 million and $ 0.0 million, respectively. The write-down of commercial inventory for the nine months ended September 30, 2024 and 2023 was $ 0.8 million and $ 0.0 million, respectively. The write - down for the nine months ended September 30, 2024 consisted of $ 0.2 million of inventory write down adjustments to list price for the first quarter of 2024, $ 0.5 million for the write-down of short dated inventory to net realizable value for the second quarter of 2024 and $ 0.1 million for the write - down of inventory to net realizable value for the third quarter of 2024. The Company recorded the write-downs to cost of revenue as it relates to goods that were part of commercial inventory during 2024. 9 Table of Contents EYENOVIA, INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED) Net Loss Per Share of Common Stock Basic net loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period, plus fully vested shares that are subject to issuance for little or no monetary consideration. Diluted loss per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock. The following table presents the computation of basic and diluted net loss per common share: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Three Months Ended ​ For the Nine Months Ended ​ ​ September 30, ​ September 30, ​ 2024 2023 2024 2023 Numerator: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Net loss attributable to common stockholders ​ $ ( 7,887,853 ) ​ $ ( 7,338,733 ) ​ $ ( 29,863,653 ) ​ $ ( 19,293,959 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Denominator (weighted average quantities): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Common shares issued ​ 69,316,561 ​ 39,107,338 ​ ​ 56,298,569 ​ ​ 38,192,414 Add: Prefunded warrants ​ — ​ 926,225 ​ ​ — ​ ​ 305,349 Add: Undelivered vested restricted shares ​ 241,764 ​ 106,134 ​ ​ 178,307 ​ ​ 65,311 Denominator for basic and diluted net loss per share ​ 69,558,325 ​ 40,139,697 ​ ​ 56,476,876 ​ ​ 38,563,074 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Basic and diluted net loss per common share ​ $ ( 0.11 ) ​ $ ( 0.18 ) ​ $ ( 0.53 ) ​ $ ( 0.50 ) ​ The following securities are excluded from the calculation of weighted average diluted shares of common stock because their inclusion would have been anti-dilutive: ​ ​ ​ ​ ​ ​ ​ ​ September 30, ​ 2024 2023 Warrants 28,947,744 10,926,554 Options 6,695,042 5,218,686 Convertible notes ​ 2,327,747 ​ 2,327,747 Restricted stock units 368,886 86,205 Total potentially dilutive shares 38,339,419 18,559,192 ​ Subsequent Events The Company has evaluated subsequent events through the date which the financial statements were issued. Based upon the evaluation, the Company did not identify any recognized or non-recognized subsequent events that would have required adjustment or disclosure in the financial statements, except as disclosed. Recently Issued Accounting Standards In November 2023, the FASB issued ASU 2023-07, Improvements to Reportable Segments Disclosures (Topic 280), which updates reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses on both an annual and interim basis. The guidance becomes effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. Since this new ASU addresses only disclosures, the Company does not expect the adoption of this ASU to have any material effects on its financial condition, results of operations or cash flows. The Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2023-07. 10 Table of Contents EYENOVIA, INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED) In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The amendments in this update address investor requests for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. This update also includes certain other amendments to improve the effectiveness of income tax disclosures. The amendments in ASU 2023-09 are effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of this standard, but does not expect it to have a material impact on its financial statements. ​ Note 3 – Prepaid Expenses and Other Current Assets As of September 30, 2024 and December 31, 2023, prepaid expenses and other current assets consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, December 31, ​ 2024 2023 Prepaid insurance expenses ​ $ 356,214 ​ $ 167,338 Payroll tax receivable ​ ​ 288,705 ​ ​ 500,684 Prepaid general and administrative expenses ​ ​ 131,606 ​ ​ 85,938 Prepaid patent expenses ​ 71,073 ​ 48,409 Prepaid conference expenses ​ 54,810 ​ 123,556 Prepaid research and development expenses ​ ​ 48,172 ​ ​ 421,056 Prepaid rent and security deposit ​ 18,750 ​ 18,750 Other ​ ​ 18,424 ​ ​ — Total prepaid expenses and other current assets ​ $ 987,754 ​ $ 1,365,731 ​ ​ Note 4 - Intangible Assets On August 15, 2023, the Company entered into a license agreement (the “Formosa License”) with Formosa Pharmaceuticals Inc. (“Formosa”), whereby the Company acquired the exclusive U.S. rights to commercialize any product related to a novel formulation of clobetasol propionate ophthalmic suspension, 0.05 % (the “Formosa Licensed Product”), which was approved by the FDA for ophthalmic use for inflammation and pain after ocular surgery and supplemental disease indications, if any, associated with the New Drug Application for the Formosa Licensed Product. The Formosa License will remain in effect for ten years from the date of the first commercial sale of a Formosa Licensed Product, unless earlier terminated. The Company paid Formosa the aggregate amount of $ 2.0 million (the “Upfront Payment”), consisting of (a) cash in the amount of $ 1.0 million and (b) 487,805 shares of common stock, which is included in Intangible Assets on the accompanying balance sheet. The Company also capitalized $ 122,945 of transaction costs, which were primarily legal expenses. In addition to the Upfront Payment, the Company must pay Formosa up to $ 4.0 million upon the achievement of certain development milestones and up to $ 80.0 million upon the achievement of certain sales milestones. The trigger for the initial $ 2.0 million development milestone payments was FDA approval of the Formosa Licensed Product and the effective date of the acceptance by the Company of the transfer and assignment of the FDA approval. This occurred on March 14, 2024. Under the provisions of the Formosa License, the Company had 45 days from the effective date of acceptance of the transfer and assignment of FDA approval to make the payment half in cash and half in common stock, otherwise the payment due would revert to be fully in cash. The Company paid Formosa the aggregate amount of $ 2.0 million, consisting of (a) cash in the amount of $ 1.0 million on April 26, 2024 and (b) 613,496 shares of common stock on April 29, 2024 (calculated pursuant to the Formosa License using a five-day volume-weighted average price on March 14, 2024, but valued at $ 0.4 million on the April 29, 2024 settlement date, resulting in a $ 0.6 million change in fair value of the equity consideration payable), which is included in Intangible Assets on the accompanying balance sheet as of September 30, 2024. The second $ 2.0 million development milestone (to be fully paid in cash) was earned upon FDA approval of the Formosa Licensed Product and payment was triggered on the earlier of twelve months after FDA approval or six months following the first commercial sale of the Formosa Licensed Product. Because the payment became probable and estimable, the Company recorded an additional $ 2.0 million increase in the intangible asset and the related accrual on March 14, 2024. 11 Table of Contents EYENOVIA, INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED) Note 5 – Accrued Compensation As of September 30, 2024 and December 31, 2023, accrued compensation consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, December 31, ​ 2024 2023 Accrued bonus expenses ​ $ 1,141,884 ​ $ 1,302,997 Accrued payroll expenses ​ 514,948 ​ 355,616 Total accrued compensation ​ $ 1,656,832 ​ $ 1,658,613 ​ ​ Note 6 – Accrued Expenses and Other Current Liabilities As of September 30, 2024 and December 31, 2023, accrued expenses and other current liabilities consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, December 31, ​ 2024 2023 Accrued intangible asset milestone obligation ​ $ 2,000,000 ​ $ — Accrued defective clinical supply settlement, net ​ ​ 250,000 ​ ​ 100,000 Accrued clinical studies costs ​ ​ 121,588 ​ ​ — Accrued professional services ​ ​ 79,042 ​ ​ 63,028 Credit card payable ​ ​ 29,502 ​ ​ 27,193 Accrued franchise tax ​ ​ 15,000 ​ ​ — Accrued research and development expenses ​ ​ 13,550 ​ ​ 89,872 Other ​ ​ 9,404 ​ ​ 7,835 Total accrued expenses and other current liabilities ​ $ 2,518,086 ​ $ 287,928 ​ ​ Note 7 – Notes Payable and Convertible Notes Payable As of September 30, 2024 and December 31, 2023, notes payable and convertible notes payable consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, 2024 December 31, 2023 ​ Notes Payable Debt Discount Net Notes Payable Debt Discount Net Current portion: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ D&O insurance policy loan ​ $ 64,637 ​ $ — ​ $ 64,637 ​ $ — ​ $ — ​ $ — Avenue - Note payable ​ ​ 6,666,667 ​ ​ ( 562,711 ) ​ ​ 6,103,956 ​ ​ 5,833,333 ​ ​ ( 503,914 ) ​ ​ 5,329,419 Avenue - Convertible note payable ​ ​ 3,333,333 ​ ​ ( 72,467 ) ​ ​ 3,260,866 ​ ​ — ​ ​ — ​ ​ — Total current portion ​ $ 10,064,637 ​ $ ( 635,178 ) ​ $ 9,429,459 ​ $ 5,833,333 ​ $ ( 503,914 ) ​ $ 5,329,419 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Non-Current portion: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Avenue - Note payable ​ $ 637,500 ​ $ — ​ $ 637,500 ​ $ 4,804,167 ​ $ ( 448,367 ) ​ $ 4,355,800 Avenue - Convertible note payable ​ ​ 1,666,666 ​ ​ ( 163,051 ) ​ ​ 1,503,615 ​ ​ 5,000,000 ​ ​ ( 398,569 ) ​ ​ 4,601,431 Total non-current portion ​ $ 2,304,166 ​ $ ( 163,051 ) ​ $ 2,141,115 ​ $ 9,804,167 ​ $ ( 846,936 ) ​ $ 8,957,231 ​ On February 24, 2024, the Company issued a note payable in the amount of $ 505,050 for the purchase of a directors and officers’ liability insurance policy (the “D&O Loan”). The note accrued interest at a rate of 8.15 % per year and matured on October 24, 2024. The D&O Loan was payable in eight monthly payments of $ 65,076 consisting of principal and interest. During the nine months ended September 30, 2024, the Company repaid $ 440,413 of principal owed on the D&O Loan. The note was paid off in full on the maturity date. 12 Table of Contents EYENOVIA, INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED) In June 2024, the Company began making principal payments related to that certain loan and security agreement (the “Loan and Security Agreement”) with Avenue Capital Management II, L.P. and related entities (together, “Avenue”) in the amount of $ 833,333 per month plus interest. During the three months ended September 30, 2024, the Company recorded interest expense of $ 602,109 , of which $ 598,188 (including amortization of debt discount of $ 184,207 ) was related to the Avenue loan and $ 3,921 was related to the D&O Loan. During the nine months ended September 30, 2024, the Company recorded interest expense of $ 1,954,768 , of which $ 1,939,650 was related to the Loan and Security Agreement (including amortization of debt discount of $ 552,620 ) and $ 15,118 was related to the D&O Loan. ​ Note 8 – Commitments and Contingencies Defective Clinical Supply During the third quarter of 2023, a certain portion of clinical supply product sold by the Company to Bausch + Lomb was determined to be defective. On April 23, 2024, the Company and Bausch + Lomb executed a letter agreement (the “Side Letter”) pursuant to which the Company and Bausch + Lomb agreed that the Company would pay approximately $ 0.5 million to Bausch + Lomb related to the defective clinical supply. Accordingly, the Company recorded an estimated charge equal to $ 0.4 million, which was included within other income (expense) during the year ended December 31, 2023, because the original sales to the licensee were recorded on that line item. During the three and nine months ended September 30, 2024, the Company recorded no additional charge and a $ 0.1 million charge, respectively, to other income (expense). Bausch License Agreements On October 9, 2020, the Company entered into a license agreement (the Bausch License Agreement”), pursuant to which Bausch + Lomb was permitted to develop and commercialize the Bausch Licensed Product (as defined in the Bausch License Agreement) in the United States and Canada (the “Licensed Territory”). Bausch + Lomb could terminate the Bausch License Agreement, with respect to the Bausch Licensed Product to either country in the Licensed Territory, at any time for convenience upon 90 days’ written notice. On January 12, 2024, the Company and Bausch + Lomb entered into a mutual termination and reassignment agreement (the “Letter Agreement”), pursuant to which Eyenovia reacquired the rights to the Bausch Licensed Product. The terms of the agreement include the immediate transfer of the rights and the subsequent transfer of certain assets relating to the Bausch Licensed Product from Bausch + Lomb to the Company in exchange for cash and common stock consideration. In addition, under the terms of the Letter Agreement, the Company agreed to pay Bausch + Lomb a low single-digit royalty on its net sales of the Bausch Licensed Product in the United States and Canada for a period of ten years from the date of the first commercial sale by the Company (or its affiliates or licensees) of the Bausch Licensed Product in the United States. Under the Letter Agreement, (i) the Company will re-acquire any and all licenses and other rights granted by the Company to Bausch + Lomb under the original Bausch License Agreement, (ii) any and all licenses and other rights granted by Bausch + Lomb to the Company under the License Agreement are terminated, other than as set forth in the Letter Agreement, and (iii) other than as set forth in the Letter Agreement, Bausch + Lomb is released from all of their ongoing obligations under the License Agreement, including development and commercialization obligations. Pursuant to the Letter Agreement, the Company paid Bausch + Lomb an upfront payment of $ 2.0 million in cash on January 22, 2024. The Company recorded this amount as an operating expense. In connection with the entry into the Letter Agreement, the Company also agreed to issue Bausch + Lomb $ 3.0 million in shares of the Company’s common stock, following the Regulatory Transfer Date (the “Transfer Date”). On April 11, 2024, the Transfer Date, the transfer of the rights and certain assets relating to the CHAPERONE trial from Bausch + Lomb to the Company, was completed. On May 3, 2024, the Company issued Bausch + Lomb 2,299,397 shares of the Company’s common stock (calculated pursuant to the Letter Agreement at $ 3.0 million using a thirty-day volume-weighted average price on April 11, 2024, but valued at $ 2.3 million on the May 3, 2024 settlement date, resulting in a $ 0.7 million change in fair value of the equity consideration payable), in satisfaction of its obligations pursuant to the Letter Agreement. Pursuant to the Side Letter described above (see Defective Clinical Supply), the Company agreed to pay approximately $ 0.5 million to Bausch + Lomb related to the defective clinical supply. It was also agreed that the Company will receive approximately $ 0.25 million from Bausch + Lomb to fund the vendor hold back liability that will be due upon completion of the CHAPERONE study. The Company 13 Table of Contents EYENOVIA, INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED) recorded the payable to Bausch + Lomb in the amount of $ 0.25 million. In addition, the Company purchased $ 0.5 million of clinical supplies from Bausch + Lomb in April 2024. Operating Leases A summary of the Company’s right-of-use assets and liabilities is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Nine Months Ended September 30, ​ ​ ​ 2024 2023 ​ Cash paid for amounts included in the measurement of lease liabilities: ​ ​ ​ ​ ​ Operating cash flows used in operating activities ​ $ 352,836 ​ $ 411,266 ​ ​ ​ ​ ​ ​ ​ ​ ​ Right-of-use assets obtained in exchange for lease obligations ​ ​ ​ ​ ​ Operating leases ​ $ — ​ $ 904,437 ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Average Remaining Lease Term (Years) ​ ​ ​ ​ ​ Operating leases ​ 2.37 ​ ​ 3.28 ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Average Discount Rate ​ ​ ​ ​ ​ Operating leases ​ 10.0 % ​ 10.0 % ​ Future minimum payments under the Company’s operating lease agreements are as follows: ​ ​ ​ ​ ​ For the Years Ending December 31, Minimum Lease Payments 2024 ​ $ 183,092 2025 ​ 675,400 2026 ​ 560,996 2027 ​ 214,618 Total future minimum lease payments ​ 1,634,106 Less: Imputed interest ​ ​ ( 193,025 ) Present value of lease liabilities ​ 1,441,081 Less: current portion ​ ( 604,647 ) Lease liabilities, non-current portion ​ $ 836,434 ​ Litigations, Claims and Assessments The Company may be involved in legal proceedings, claims and assessments arising in the ordinary course of business. The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements. ​ Note 9 – Related Party Transactions The Company has an advisory service agreement with a member of the board of directors. The agreement calls for a monthly consulting fee of $ 5,000 , paid on a quarterly basis, which is in addition to the compensation paid to the individual pursuant to the Company’s non - employee director compensation policy while such individual remains a member of the board of directors. ​ 14 Table of Contents EYENOVIA, INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED) Note 10 – Stockholders’ Equity Increase in Authorized Number of Shares of Common Stock On June 12, 2024, at the Annual Shareholders’ Meeting, the Company proposed and the shareholders approved an increase in the authorized number of shares of the Company’s common stock from 90,000,000 to 300,000,000 at the same par value of $ 0.0001 per share. Common Stock Issuances Pursuant to the License and certain milestone achievements, the Company issued 613,496 shares of common stock valued at $ 0.4 million on April 29, 2024 to Formosa (see Note 4 – Intangible Assets). On May 3, 2024, the Company issued Bausch + Lomb 2,299,397 shares of the Company’s common stock, valued at $ 2.3 million, in satisfaction of its obligations pursuant to the Letter Agreement (see Note 8 – Commitments and Contingencies). At-The-Market Program During the nine months ended September 30, 2024, the Company received approximately $ 6.0 million in net proceeds from the sale of 5,630,556 shares of its common stock pursuant to a sales agreement (the “Sales Agreement”) with Leerink Partners, LLC, formerly known as SVB Securities LLC (“Leerink Partners”) in an ”at-the-market” offering. Offerings Second Quarter Offering On April 8, 2024, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with a single fundamentals-based healthcare investor (the “Purchaser”), pursuant to which the Company agreed to sell, in a registered direct offering by the Company directly to the Purchaser (the “April Offering”), 3,223,726 shares of common stock. The price per share in the April Offering was $ 0.6204 . The aggregate gross proceeds to the Company from the April Offering were $ 2.0 million, and net proceeds after offering costs were approximately $ 1.9 million. Third Quarter Offerings A summary of the offerings for the third quarter is presented below: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional Total ​ ​ Common Stock ​ Paid-In ​ Stockholders’ ​ Shares Amount Capital Equity July Offering 7,575,757 ​ $ 758 ​ $ 4,298,643 ​ $ 4,299,401 August Offering 12,850,000 ​ 1,285 ​ 4,449,822 ​ 4,451,107 September Offering 8,630,000 ​ 863 3,596,807 ​ 3,597,670 ​ 29,055,757 ​ $ 2,906 ​ $ 12,345,272 ​ $ 12,348,178 ​ July Offering and Warrant Amendment On July 1, 2024, the Company closed on a registered direct offering (the “July Offering”) with certain institutional and accredited investors (the “July Investors”), pursuant to which the Company sold 7,575,757 shares of common stock and warrants to purchase up to 7,575,757 shares of common stock. The combined offering price for each share of common stock and accompanying warrant was $ 0.66 . The Company also agreed to issue warrants to purchase an additional 1,749,780 shares of common stock (the “Additional Warrants”) to one of the July Investors. All of the new warrants become exercisable six months following their issuance, at an exercise price of $ 0.69 per share, and may be exercised until January 2, 2030. 15 Table of Contents EYENOVIA, INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED) In connection with the July Offering, the Company entered into warrant amendment agreements (the “Amendments”) with the holders of previously issued warrants (the “Prior Warrants”) to purchase up to an aggregate of 10,386,269 shares of common stock, whereby the Company agreed to amend the Prior Warrants to reduce the exercise price of the Prior Warrants from $ 2.23 and $ 2.47 per share of common stock to $ 0.69 per share of common stock, extend the term of the Prior Warrants until January 2, 2030 and prohibit exercise of the Prior Warrants for the six-month period following the effective date of the Amendments. The aggregate gross proceeds to the Company from the July Offering were approximately $ 5.0 million, and net proceeds after cash offering costs were approximately $ 4.3 million. Offering costs include placement agent fees of $ 0.4 million and Company legal fees of $ 0.3 million. In addition, there were $ 2.9 million of non-cash issuance costs which represents the value of the Additional Warrants, plus the modification date incremental value of the modified Prior Warrants as compared to the original Prior Warrants, as an issuance cost of the warrant exercise. August Offering On August 21, 2024, the Company agreed to sell 12,850,000 shares of common stock to certain institutional and accredited investors (the “August Investors”), in some cases pursuant to a securities purchase agreement (the “August Offering”). The price per share in the August Offering was $ 0.40 . The aggregate gross proceeds to the Company from the August Offering were approximately $ 5.1 million, and net proceeds after offering costs were approximately $ 4.5 million. September Offering On September 30, 2024, the Company closed on a registered direct offering (the “September Offering”) with a certain purchaser, pursuant to which the Company sold to the purchaser 8,630,000 shares of common stock; pre-funded warrants to purchase up to 65,653 shares of common stock; and warrants to purchase up to 8,695,653 shares of common stock at an exercise price of $ 0.50 per share. The combined offering price for each share and accompanying warrant was $ 0.46 . The combined offering price for each pre-funded warrant and accompanying Warrant was $ 0.4599 , which is equal to the purchase price per share in the September Offering, minus $ 0.0001 , the exercise price per share of the pre-funded warrants. The warrants will be exercisable beginning six months following the date of issuance and may be exercised until March 31, 2030. The aggregate gross proceeds to the Company from the September Offering were approximately $ 4.0 million, and net proceeds after offering costs were approximately $ 3.6 million. Warrants The issuance date or modification date fair value of stock warrants issued or modified during the three and nine months ended September 30, 2024 and 2023 was determined using the Black Scholes method, with the following assumptions used: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Three Months Ended ​ For the Nine Months Ended ​ ​ September 30, ​ September 30, ​ 2024 2023 2024 2023 Fair value of common stock on date of grant $ 0.68 ​ $ 1.97 $ 0.68 ​ $ 1.97 ​ Risk free interest rate 4.39 % - 5.22 % ​ 4.48 % ​ 4.39 % - 5.22 % ​ 4.48 % ​ Expected term (years) 0.7 - 5.5 years ​ 4.0 - 5.5 years ​ 0.7 - 5.5 years ​ 4.0 - 5.5 years ​ Expected volatility 86 % - 118 % ​ 81 % ​ 86 % - 118 % ​ 81 % ​ Expected dividends n/a ​ n/a ​ n/a ​ n/a ​ ​ 16 Table of Contents EYENOVIA, INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED) A summary of the warrant activity during the nine months ended September 30, 2024 is presented below: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ Weighted ​ Average ​ ​ ​ ​ Average ​ Remaining ​ ​ Number of ​ Exercise ​ Life ​ Warrants Price In Years Outstanding January 1, 2024 10,926,554 ​ $ 2.28 Granted (1) 18,021,190 ​ 0.60 Repriced - (Old) (2) ( 10,386,269 ) ​ 2.25 Repriced - (New) (2) 10,386,269 ​ 0.69 Exercised — ​ — Outstanding September 30, 2024 (1) 28,947,744 ​ $ 0.67 5.1 ​ ​ ​ ​ ​ ​ ​ ​ Exercisable September 30, 2024 (1) 540,285 ​ $ 2.96 1.4 (1) - Warrants granted, outstanding and exercisable exclude 65,653 pre-funded warrants with an exercise price of $ 0.0001 . (2) - Repriced warrants represent the reset of the exercise price of certain warrants to purchase 10,386,269 shares of common stock to a price of $ 0.69 per share. The following table presents information related to warrants as of September 30, 2024: ​ ​ ​ ​ ​ ​ ​ Warrants Outstanding (1) Warants Exercisable (1) ​ ​ Weighted ​ ​ ​ ​ ​ ​ Outstanding ​ Average ​ Exercisable Exercise ​ Number of ​ Remaining Life ​ Number of Price Warrants In Years Warrants $ 0.5000 8,695,653 (2) — — $ 0.6900 19,711,806 (3) — — $ 2.4696 232,021 0.5 232,021 $ 2.7240 216,380 0.5 216,380 $ 4.7600 91,884 6.6 91,884 ​ 28,947,744 1.4 540,285 (1) - Warrants outstanding and exercisable exclude 65,653 Pre-Funded Warrants with an exercise price of $ 0.0001 . (2) - These warrants become exercisable on March 26, 2025. (3) - These warrants become exercisable on January 1, 2025. ​ Stock-Based Compensation Expense The Company records stock-based compensation expense related to stock options and restricted stock units (“RSUs”). For the three months ended September 30, 2024 and 2023, the Company recorded stock-based compensation expense of $ 452,998 ($ 179,776 of which was included within research and development expenses and $ 273,222 was included within selling, general and administrative expenses on the statements of operations) and $ 612,969 ($ 235,731 of which was included within research and development expenses and $ 377,238 of which was included within selling, general and administrative expenses on the statements of operations), respectively. For the nine months ended September 30, 2024 and 2023, the Company recorded stock-based compensation expense of $ 1,540,286 ($ 618,516 of which was included within research and development expenses and $ 921,770 of which was included within selling, general and administrative expenses on the statements of operations) and $ 1,925,665 ($ 647,058 of which was included within research and development expenses and $ 1,278,607 of which was included within selling, general and administrative expenses on the statements of operations), respectively. 17 Table of Contents EYENOVIA, INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED) Restricted Stock Units A summary of the restricted stock units (“RSUs”) activity during the nine months ended September 30, 2024 is presented below: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ Average ​ ​ Number of ​ Exercise ​ RSUs Price RSUs non-vested January 1, 2024 106,019 ​ $ 2.12 Granted 368,886 ​ 0.65 Vested ( 106,019 ) ​ 2.12 Forfeited — ​ — RSUs non-vested September 30, 2024 368,886 ​ $ 0.65 Vested RSUs undelivered September 30, 2024 241,764 ​ $ 2.17 ​ To date, RSUs have only been granted to directors in accordance with the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan. The Company’s policy is not to deliver shares underlying the RSUs until a director’s termination of service. As of September 30, 2024, there was $ 169,739 of unrecognized stock-based compensation expense related to RSUs which will be recognized over a weighted average period of 0.7 years. Stock Options A summary of the option activity during the nine months ended September 30, 2024 is presented below: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ Weighted Average ​ ​ ​ ​ ​ ​ Average Remaining Aggregate ​ Number of Exercise Life Intrinsic ​ Options Price In Years Value Outstanding, January 1, 2024 5,306,377 ​ ​ 3.31 ​ Granted 2,188,136 ​ 1.10 ​ Exercised — ​ — ​ Forfeited/Expired ( 799,471 ) ​ ​ 3.26 ​ ​ ​ ​ Outstanding, September 30, 2024 ​ 6,695,042 ​ $ 2.59 ​ 7.2 ​ $ 44,053 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Exercisable, September 30, 2024 4,022,998 ​ $ 3.46 5.8 ​ $ — ​ The following table presents information related to stock options as of September 30, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ Options Outstanding Options Exercisable ​ ​ ​ Weighted ​ ​ ​ ​ Average ​ Exercise Number of Remaining Life Number of Price Options In Years Options $ 0.01 - $ 0.99 1,315,136 ​ — — $ 1.00 - $ 1.99 2,224,213 ​ 5.4 1,160,055 $ 2.00 - $ 2.99 1,249,586 ​ 6.7 1,026,448 $ 3.00 - $ 3.99 758,637 ​ 6.0 703,605 $ 4.00 - $ 4.99 279,000 ​ 7.0 264,420 $ 5.00 - $ 5.99 26,668 ​ 2.0 26,668 $ 6.00 - $ 6.99 691,162 ​ 5.2 691,162 $ 7.00 + ​ 150,640 ​ 3.5 ​ 150,640 ​ ​ ​ 6,695,042 ​ 5.8 ​ 4,022,998 18 Table of Contents EYENOVIA, INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED) ​ In applying the Black-Scholes option pricing model to stock options granted, the Company used the following approximate assumptions: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Three Months Ended ​ For the Nine Months Ended ​ ​ September 30, ​ September 30, ​ 2024 2023 2024 2023 Expected term (years) ​ 5.85 - 6.25 N/A ​ ​ 5.50 - 10.00 ​ ​ 5.50 - 10.00 Risk free interest rate ​ 3.47 % - 3.80 % ​ N/A ​ ​ 3.47 % - 4.72 % ​ ​ 3.44 % - 4.18 % Expected volatility ​ 87 % ​ N/A ​ ​ 80 % - 87 % ​ ​ 82 % - 95 % Expected dividends ​ 0.00 % ​ N/A ​ ​ 0.00 % ​ ​ 0.00 % ​ As of September 30, 2024, there was $ 2,042,227 of unrecognized stock-based compensation expense related to stock options which will be recognized over a weighted average period of 1.8 years. The weighted average estimated grant date fair value of the stock options granted for the three months ended September 30, 2024 was approximately $ 0.40 per share. There were no options granted in the three months ended September 30, 2023. The weighted average estimated grant date fair value of the stock options granted for the nine months ended September 30, 2024 and 2023 was approximately $ 0.79 and $ 1.70 per share, respectively. ​ Note 11 – Employee Benefit Plans 401(k) Plan In April 2019, the Company adopted the Eyenovia 401(k) Plan (the “Plan”), which went into effect in May 2019. All Company employees are able to participate in the Plan, subject to eligibility requirements as outlined in the Plan documents. Under the terms of the Plan, eligible employees are able to defer a percentage of their pay every pay period up to annual limitations set by Congress and the Internal Revenue Service under Section 401(k) of the Internal Revenue Code. The Company’s Board of Directors approved a matching contribution equal to 100 % of elective deferrals up to 4 % of eligible earnings with the matching contribution subject to certain vesting requirements as outlined in the Plan documents. During the three months ended September 30, 2024 and 2023, the Company recorded expense of $ 56,493 ( $ 41,186 which was included within research and development expenses and $ 15,307 was included within selling, general and administrative expenses on the statements of operations) and $ 46,636 ( $ 37,383 of which was included within research and development expenses and $ 9,253 of which was included within selling, general and administrative expenses on the statements of operations), respectively, associated with its matching contributions. During the nine months ended September 30, 2024 and 2023, the Company recorded expense of $ 220,682 ( $ 136,598 of which was included within research and development expenses and $ 84,084 of which was included within selling, general and administrative expenses on the statements of operations) and $ 171,800 ( $ 115,559 of which was included within research and development expenses and $ 56,241 of which was included within selling, general and administrative expenses on the statements of operations) associated with its matching contributions, respectively. Note 12 - Subsequent Events Exercise of Pre-Funded Warrants On October 1, 2024, the holder of the 65,653 pre-funded warrants issued in the September Offering, exercised the pre-funded warrants at a price of $ 0.0001 per share of common stock (see Note 10 - Stockholders’ Equity - Offerings). ​ ​ 19 Table of Contents