Nitisinone

Record revenue, with Q2 2026 product sales of $37.6 million, representing 99% growth over Q2 2025 Q2 2026 fully diluted GAAP EPS of $0.35, non-GAAP fully diluted EPS of $0.43; EBITDA of $14.1 million, Adjusted EBITDA of $16.2 million Raising full year revenue guidance, with 2026 revenue now expected to exceed $145 million, up from previous guidance of more than $120 million Relaunched HEMANGEOL ® May 1 st , patient conversion completed ahead of schedule Acquired late-stage product candidate ASN-001, expanding the Company’s infantile hemangioma franchise, and providing a potential high-value 2027 NDA submission Submitted Prior Approval Supplement to the FDA to expand indication of KHINDIVI ® , allowing for potential H1 2027 approval of expanded indication Received FDA Fast Track designation for endocrinology development product AMGLIDIA ® Acquired U.S. commercialization rights to orphan drug IMPAVIDO ® Management to hold conference call today at 4:30pm ET DEER PARK, Ill., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported financial results for the quarter ended June 30, 2026. “Eton reported another outstanding quarter, delivering 99% year-over-year revenue growth, reflecting the strength of our rare disease portfolio and the exceptional execution of our team. Our HEMANGEOL relaunch is off to a strong start, with the patient conversion completed ahead of schedule, positioning our therapy for continued momentum and furthering our mission to allow more infants with infantile hemangiomas to benefit from timely treatment. In addition, we further expanded our commitment to the infantile hemangioma community with the licensing of ASN-001, an exciting late-stage development program that is expected to further improve care and broaden treatment options for families, while potentially becoming the largest revenue opportunity in our pipeline. The rest of our portfolio continued to deliver in the quarter, with strong contributions from our entire pediatric endocrinology franchise, including the recently launched DESMODA™, and our metabolic products,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “Given our first half performance and strong outlook for the remainder of the year, we’re pleased to again raise our annual revenue guidance and now expect at least $145 million of revenue this year. We are also raising our adjusted EBITDA guidance, which includes the additional expenses related to the ASN-001 transaction and development. We now expect to deliver an Adjusted EBITDA margin of at least 35%,” concluded Brynjelsen. Second Quarter and Recent Business Highlights Record revenues with 99% growth year-over-year. Eton reported second quarter 2026 revenues of $37.6 million, compared to $18.9 million in the prior year period, driven by the addition of sales from HEMANGEOL plus strong growth from across the portfolio. HEMANGEOL relaunched successfully, ensuring continuity of care for patients and families. The Company relaunched HEMANGEOL in May, offering full Eton Cares patient support, which provides comprehensive access and affordability services including $0 copay for all eligible patients. The transition to Eton’s program exceeded expectations, with approximately 95% of existing patients successfully transitioned by the end of June. Expanded presence in infantile hemangioma with licensing of product candidate ASN-001. Last week, Eton announced the licensing of product candidate ASN-001, which is under development for the treatment of moderate infantile hemangiomas. ASN-001 would complement Eton’s HEMANGEOL franchise and leverage the same commercial infrastructure. The Company plans to initiate a bioavailability study and anticipates a New Drug Application (“NDA”) submission upon the study’s completion in the second half of 2027. If approved, Eton believes ASN-001 offers the largest revenue opportunity in its pipeline. Strong year-over-year growth in pediatric endocrinology portfolio. DESMODA, which launched in March, continues to see strong adoption and patient growth while the three other products in the Company’s pediatric endocrinology portfolio all posted strong year-over-year revenue growth in the second quarter. The Company's adrenal franchise, consisting of ALKINDI SPRINKLE and KHINDIVI, surpassed 600 active patients on therapy, reflecting continued confidence from pediatric endocrinologists. INCRELEX continued to deliver strong growth, driven by appropriate dose optimization and sustained treatment, reflecting the Company's commitment to helping patients achieve the best possible outcomes. Completed KHINDIVI label expansion study and submitted Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration (FDA) requesting expansion of indication. The new formulation of KHINDIVI successfully demonstrated bioequivalence to ALKINDI SPRINKLE, paving the way for a potential first half of 2027 approval. The Company believes the largest unmet need for an FDA-approved oral liquid hydrocortisone remains with children under age five, and that an expanded label would dramatically increase adoption. Acquired exclusive U.S. commercialization rights to Orphan Drug IMPAVIDO. In June, Eton announced the acquisition of IMPAVIDO, a critical, life-saving medication, adding an additional 2026 product launch. The product is FDA-approved, and Eton expects to begin commercializing the product in September 2026. Pediatric endocrinology development product candidate AMGLIDIA was granted Fast Track designation by FDA. The Fast Track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The Company plans to initiate a bioavailability study for the product later this month and remains on track to submit an NDA by the end of 2026, allowing for potential approval and launch in 2027. Continued to advance Wilson disease franchise. In addition to a strong quarter of patient additions for GALZIN, the Company’s pilot study for product candidate ET-700, its proprietary, patent-pending, extended-release formulation of zinc acetate, is underway. The study is comparing ET-700 to GALZIN and placebo. If pilot study results are successful, Eton anticipates initiating a pivotal clinical study in early 2027. Executed INCRELEX label harmonization study agreement with Clinical Research Organization; site preparation is underway. Earlier this year, Eton received clearance from the FDA to proceed with its proposed label harmonization study, designed to support an application to broaden the approved definition of severe primary IGF-1 deficiency (SPIGFD) to match the E.U. definition. If successful, this could increase the addressable population in the U.S. from an estimated 200 to 1,000 patients. The Company has initiated study preparation activities with a goal of having the first patients dosed by the end of 2026. Guidance The Company now expects 2026 revenues to exceed $145 million, an increase from prior guidance of more than $120 million. In addition, the Company now expects to report at least a 35% Adjusted EBITDA margin, an increase from prior guidance of at least 30%. The revised Adjusted EBITDA guidance is inclusive of a $3 million licensing payment for ASN-001 which will be expensed in the third quarter, incremental second half R&D expenses related to ASN-001’s bioavailability study, and a potential, one-time $4 million commercial milestone payment related to ALKINDI SPRINKLE sales performance, which may be triggered in the fourth quarter of 2026. Second quarter Financial Results Net Revenue: Total net revenue for the second quarter of 2026 was $37.6 million compared to $18.9 million in the prior year period, an increase of 99%, driven by the addition of revenue from HEMANGEOL, as well as year-over-year growth across the portfolio, in particular INCRELEX, ALKINDI SPRINKLE, GALZIN and Carglumic Acid. Second quarter 2026 revenue included $2.9 million of revenue from INCRELEX and GALZIN sales outside the United States. Gross Profit: Gross profit for the second quarter of 2026 was $25.4 million compared with $11.9 million in the prior year period, an increase of 113%, primarily due to increased product sales. Adjusted gross profit, which adjusts for the impact of acquired inventory step-up adjustments and intangible amortization, was $27.4 million in the second quarter of 2026, representing an adjusted gross margin of 73%, compared to adjusted gross profit of $14.1 million and adjusted gross margin of 75% in the prior year period. The decrease in adjusted gross margin in the second quarter of 2026 was due to higher INCRELEX sales outside the United States, which generates negative gross margin. The Company expects full year 2026 adjusted gross margin to exceed 70%, inclusive of the potential $4 million commercial milestone referred to above. Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were $1.0 million compared to $3.7 million in the prior year period. The decrease was primarily due to the DESMODA NDA submission fee in the prior year period. The Company expects full year R&D expenses of between $10 and $14 million, with a significant increase in the second half of 2026 due to increased development activity, including the initiation of the INCRELEX label harmonization study, a $3 million expense related to the licensing of ASN-001, and incremental spending related to ASN-001’s planned bioavailability study. General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2026 were $11.6 million compared to $9.7 million in the prior year period, an increase of 20%. Adjusted G&A expense, which removes share-based compensation, depreciation, transaction-related costs, and other one-time expenses, was $10.2 million in the quarter, compared with $7.6 million in the prior year period. The increase was attributable to increased headcount to support the growth of the business as well as increased cost of FDA program fees as the Company no longer qualifies for the orphan fee exemption. Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA): EBITDA for the second quarter of 2026 was $14.1 million compared to ($0.3) million in the prior year period. Adjusted EBITDA for the second quarter of 2026 was $16.2 million or 43% of revenue, compared to $3.1 million or 16% of revenue in the prior year period. Net Income/Loss: Net income for the second quarter of 2026 was $11.6 million or $0.35 per diluted share compared to a net loss of $2.6 million or $0.10 per basic and diluted share in the prior year period. On a non-GAAP basis, the Company reported net income of $14.3 million or $0.43 per diluted share for the second quarter of 2026 compared to net income of $1.5 million, or $0.03 per diluted share in the prior year period. For a reconciliation of GAAP net income/(loss) to Earnings Before Interest, Taxes, Depreciation and Amortization EBITDA (“EBITDA”), Adjusted EBITDA and adjusted Non-GAAP basic and fully diluted earnings per share to the most directly comparable GAAP financial measure, please see the tables below. Cash Position : As of June 30, 2026, the Company had cash and cash equivalents of $26.8 million. Conference Call and Webcast Information As previously announced, Eton Pharmaceuticals will host its Second quarter 2026 conference call as follows: Date: August 13, 2026 Time: 4:30 p.m. ET (3:30 p.m. CT) Participant Call Link*: Click Here Webcast: Click Here In addition to taking live questions from participants on the conference call, management will be answering emailed questions from investors. Investors can email questions to: investorrelations@etonpharma.com. The live webcast can be accessed on the Investors section of Eton’s website at An archived webcast will be available on Eton’s website approximately two hours after the completion of the event and for 30 days thereafter. * Conference call participants should register to obtain their dial-in and passcode details. Please be sure to register using a valid email address. About Eton Pharmaceuticals Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has eleven commercial rare disease products: KHINDIVI ® , INCRELEX ® , ALKINDI SPRINKLE ® , DESMODA™, GALZIN ® , HEMANGEOL ® , PKU GOLIKE ® , IMPAVIDO ® (September 2026 launch), Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has five additional product candidates in late-stage development: ASN-001, AMGLIDIA ® , ET-700, ET-800, and ZENEO ® hydrocortisone autoinjector. For more information, please visit our website at . Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Non-GAAP Financial Measures In addition to the Company’s results of operations determined in accordance with U.S. generally accepted accounting principles (GAAP), which are presented and discussed above, management also utilizes Adjusted EBITDA, an unaudited financial measure that is not calculated in accordance with GAAP, to evaluate the Company’s financial results and performance and to plan and forecast future periods. Adjusted EBITDA is considered a “non-GAAP” financial measure within the meaning of Regulation G promulgated by the SEC. Management believes that this non-GAAP financial measure reflects an additional way of viewing aspects of the Company’s operations that, when viewed with GAAP results, provides a more complete understanding of the Company’s results of operations and the factors and trends affecting its business. Management believes Adjusted EBITDA provides meaningful supplemental information regarding the Company’s performance because (i) it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making; (ii) it excludes the impact of non-cash or, when specified, non-recurring items that are not directly attributable to the Company’s core operating performance and that may obscure trends in the Company’s core operating performance; and (iii) it is used by institutional investors and the analyst community to help analyze the Company’s results. However, Adjusted EBITDA and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the way they are calculated may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies, including the Company’s competitors. Adjusted EBITDA The Company defines Adjusted EBITDA as net income/(loss), excluding the effects of stock-based compensation and expenses, interest, taxes, depreciation, amortization, and, if any and when specified, other non-recurring income or expense items. Management believes that the most directly comparable GAAP financial measure to Adjusted EBITDA is net income/(loss). Adjusted EBITDA has limitations and should not be considered as an alternative to gross profit or net income/(loss) as a measure of operating performance or to net cash provided by (used in) operating, investing, or financing activities as a measure of ability to meet cash needs. Investor Relations: Lisa M. Wilson, In-Site Communications, Inc. T: 212-452-2793 E: lwilson@insitecony.com Eton Pharmaceuticals, Inc. Condensed Statements of Operations (In thousands, except per share amounts) (Unaudited) For the three months ended For the six months ended June 30, June 30, June 30, June 30, 2026 2025 2026 2025 Revenues: Product sales, net $ 37,589 $ 18,928 $ 61,855 $ 32,924 Licensing revenue — — — 3,286 Total net revenues 37,589 18,928 61,855 36,210 Cost of sales: Product sales and royalties, net 12,176 7,004 21,707 13,600 Licensing revenue — — — 825 Total cost of sales 12,176 7,004 21,707 14,425 Gross profit 25,413 11,924 40,148 21,785 Operating expenses: Research and development 993 3,712 2,868 4,873 General and administrative 11,626 9,687 22,072 18,857 Total operating expenses 12,619 13,399 24,940 23,730 Income (loss) from operations 12,794 (1,475 ) 15,208 (1,945 ) Other expense: Interest and other expense, net (1,076 ) (1,044 ) (1,916 ) (2,072 ) Income (loss) before income tax expense 11,718 (2,519 ) 13,292 (4,017 ) Income tax expense 140 66 160 140 Net income (loss) $ 11,578 $ (2,585 ) $ 13,132 $ (4,157 ) Net income (loss) per share, basic $ 0.42 $ (0.10 ) $ 0.48 $ (0.15 ) Weighted average number of common shares outstanding, basic 27,642 26,893 27,444 26,889 Net income (loss) per share, diluted $ 0.35 $ (0.10 ) $ 0.41 $ (0.15 ) Weighted average number of common shares outstanding, diluted 32,787 26,893 32,298 26,889 Eton Pharmaceuticals, Inc. Condensed Balance Sheets (In thousands, except share and per share amounts) June 30, 2026 December 31, 2025 (Unaudited) Assets Current assets: Cash and cash equivalents $ 26,845 $ 25,942 Accounts receivable, net 24,886 11,757 Inventories, net 10,143 15,419 Prepaid expenses and other current assets 6,725 7,463 Total current assets 68,599 60,581 Property and equipment, net 352 326 Intangible assets, net 45,678 30,878 Operating lease right-of-use assets, net 1,114 310 Other long-term assets, net 64 19 Total assets $ 115,807 $ 92,114 Liabilities and stockholders ’ equity Current liabilities: Accounts payable $ 14,405 $ 10,976 Short-term debt, net of discount 8,825 8,789 Accrued Medicaid rebates 10,969 9,317 Accrued liabilities 10,925 9,408 Total current liabilities 45,124 38,490 Long-term debt, net of current portion and debt discount and accrued exit fees 19,078 21,769 Operating lease liabilities, net of current portion 1,083 460 Other long-term liabilities 3,937 5,241 Total liabilities 69,222 65,960 Stockholders ’ equity Common stock, $0.001 par value; 50,000,000 shares authorized; 28,289,941 and 27,047,061 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively 28 27 Additional paid-in capital 145,919 138,621 Accumulated deficit (99,362 ) (112,494 ) Total stockholders ’ equity 46,585 26,154 Total liabilities and stockholders ’ equity $ 115,807 $ 92,114 Eton Pharmaceuticals, Inc. Condensed Statements of Cash Flows (In thousands) (Unaudited) For the six months ended June 30, 2026 June 30, 2025 Cash flows from operating activities Net income (loss) $ 13,132 $ (4,157 ) Adjustments to reconcile net income (loss) to net cash from operating activities: Stock-based compensation 2,986 3,296 Depreciation and amortization 2,517 2,018 Inventory step-up 1,000 2,349 Excess and obsolete inventory reserve 581 110 Debt discount amortization and non-cash interest expense 278 342 Non-cash lease expense 45 30 Changes in operating assets and liabilitie: Accounts receivable (13,129 ) (9,092 ) Inventories 4,725 (11,019 ) Prepaid expenses and other assets 739 672 Accounts payable 3,429 7,970 Accrued Medicaid rebates 1,652 9,359 Accrued liabilities 704 (1,201 ) Other non-current assets and liabilities (3,999 ) 9,372 Net cash from operating activities 14,660 10,049 Cash flows used in investing activities Purchase of product licensing rights (15,000 ) — Purchase of property and equipment (70 ) — Net cash used in investing activities (15,070 ) — Cash flows from financing activities Proceeds from stock option exercises 4,043 394 Proceeds from shares issued under the ESPP 270 — Repayment of long-term debt (3,000 ) — Net cash from financing activities 1,313 394 Change in cash and cash equivalents 903 10,443 Cash and cash equivalents at beginning of period 25,942 14,936 Cash and cash equivalents at end of period $ 26,845 $ 25,379 Supplemental disclosures of cash flow information Cash paid for interest $ 1,697 $ 852 Cash paid for income taxes $ 85 $ 89 Eton Pharmaceuticals, Inc. Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP Reconciliation (in thousands, except per share amounts) (Unaudited) For the three months ended For the six months ended June 30, June 30, June 30, June 30, 2026 2025 2026 2025 GAAP Net income (loss) $ 11,578 $ (2,585 ) $ 13,132 $ (4,157 ) Depreciation (1) 22 4 44 16 Intangible amortization expense (2) 1,364 1,001 2,473 2,002 Interest expense (including debt discount amortization and non-cash interest expenses) 1,013 1,198 2,149 2,361 Income tax expense 140 66 160 140 EBITDA $ 14,117 $ (316 ) $ 17,958 $ 362 Other non-GAAP adjustments: Inventory step-up expense (3) 650 1,207 1,000 2,349 Stock-based compensation (4) 1,468 2,096 2,986 3,296 Severance expense (5) — — — 335 Acquisition/divestiture-related costs (6) — 64 — 384 Total of Other non-GAAP adjustments 2,118 3,367 3,986 6,364 Adjusted EBITDA $ 16,235 $ 3,051 $ 21,944 $ 6,726 GAAP Net income (loss) $ 11,578 $ (2,585 ) $ 13,132 $ (4,157 ) Non-GAAP adjustments: Depreciation (1) 22 4 44 16 Intangible amortization expense (2) 1,364 1,001 2,473 2,002 Inventory step-up expense (3) 650 1,207 1,000 2,349 Share-based compensation (4) 1,468 2,096 2,986 3,296 Severance expense (5) — — — 335 Acquisition/divestiture-related costs (6) — 64 — 384 Total pre-tax non-GAAP adjustments 3,504 4,372 6,503 8,382 Income tax effect of pre-tax non-GAAP adjustments (7) 735 247 806 290 Total non-GAAP adjustments 2,769 4,125 5,697 8,092 Non-GAAP Net income $ 14,347 $ 1,540 $ 18,829 $ 3,935 Weighted average number of common shares outstanding, basic 27,642 26,893 27,444 26,889 Weighted average number of common shares outstanding, diluted 32,787 31,141 32,298 31,066 GAAP income (loss) per share - Basic $ 0.42 $ (0.10 ) $ 0.48 $ (0.15 ) Non-GAAP adjustments 0.10 0.15 0.21 0.30 Non-GAAP earnings per share - Basic $ 0.52 $ 0.05 $ 0.69 $ 0.15 GAAP income (loss) per share - Diluted $ 0.35 $ (0.10 ) $ 0.41 $ (0.15 ) Non-GAAP adjustments 0.08 0.13 0.18 0.26 Non-GAAP earnings per share - Diluted $ 0.43 $ 0.03 $ 0.59 $ 0.11 (1) Represents depreciation expense related to our property and equipment. (2) Intangible amortization expenses are associated with the Company's intellectual property rights related to INCRELEX®, HEMANGEOL®, GALZIN®, PKU GOLIKE®, IMPAVIDO®, Carglumic Acid, Betaine Anhydrous and Nitisinone. (3) During the three and six months ended June 30, 2026 and 2025, the Company recognized in cost of sales $650 and $1,000, respectively, compared to $1,207 and $2,349 during the three and six months ended June 30, 2025, respectively, for inventory step-up expense primarily attributable to the HEMANGEOL® inventory revalued in connection with the product acquisition in 2026 period, and the INCRELEX® inventory revalued in connection with this product acquisition in the 2025 periods. (4) Represents share-based compensation expense associated with the Company's stock option and restricted stock unit grants to employees and non-employee directors and the Company's employee share purchase plan. (5) Represents severance and benefit expenses associated with role redundancy within commercial operations during the first quarter of 2025. (6) Represents legal expense and other divestiture-related costs associated with the out-licensing of the INCRELEX® commercial rights in territories outside of the U.S. (7) Income tax adjustments on pre-tax non-GAAP adjustments represent the estimated income tax impact of each pre-tax non-GAAP adjustment based on the effective income tax rate for the period. The Company is in a full income tax valuation allowance position and the income tax effect on pre-tax non-GAAP adjustments is commensurate with the performance measure. Eton Pharmaceuticals, Inc. Second Quarter and YTD 2026 GAAP to Non-GAAP Net Income (Loss) Reconciliation (in thousands) (Unaudited) Second Quarter 2026 GAAP Depreciation and Intangible Amortization Inventory Step-Up Expense Stock Based Compensation Severance Expense Acquisition/ Divestiture Related Costs Non- GAAP Cost of sales $ 12,176 (1,364 ) (650 ) - - - $ 10,162 Research and development 993 - - (50 ) - - 943 General and administrative 11,626 (22 ) - (1,418 ) - - 10,186 Interest and other expense, net 1,076 - - - - - 1,076 Second Quarter 2025 Cost of sales $ 7,004 (1,001 ) (1,207 ) - - - $ 4,796 Research and development 3,712 - - (39 ) - - 3,673 General and administrative 9,687 (4 ) - (2,057 ) - (64 ) 7,562 Interest and other expense, net 1,044 - - - - - 1,044 Second Quarter YTD 2026 GAAP Depreciation and Intangible Amortization Inventory Step-Up Expense Stock Based Compensation Severance Expense Acquisition/ Divestiture Related Costs Non- GAAP Cost of sales $ 21,707 (2,473 ) (1,000 ) - - - $ 18,234 Research and development 2,868 - - (99 ) - - 2,769 General and administrative 22,072 (44 ) - (2,887 ) - - 19,141 Interest and other expense, net 1,916 - - - - - 1,916 Second Quarter YTD 2025 Cost of sales $ 14,425 (2,002 ) (2,349 ) - - - $ 10,074 Research and development 4,873 - - (82 ) - - 4,791 General and administrative 18,857 (16 ) - (3,214 ) (335 ) (384 ) 14,908 Interest and other expense, net 2,072 - - - - - 2,072

ASN-001 targets the substantially larger population of moderate infantile hemangiomas currently treated off-label with topical timolol Complementary product to HEMANGEOL ® (propranolol hydrochloride) oral solution, positioning Eton, if approved, to treat full spectrum of infantile hemangioma patients ASN-001 Phase II/III trial results showed week 24 elimination or near-elimination rates of 56% (BID) and 42% (TID) compared with 15% for placebo Anticipate NDA submission in 2H 2027 for potential approval and launch in 2028 Estimated 20,000 to 30,000 patients annually could be candidates for ASN-001, pathway to potentially be the largest revenue generating product in Eton’s portfolio Leverages Eton’s existing pediatric dermatology commercial infrastructure and expands Company’s leadership in infantile hemangioma space DEER PARK, Ill., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that the Company has licensed U.S. rights to rare disease product candidate ASN-001 (timolol topical gel) from Auson Pharmaceuticals (“Auson”). ASN-001 is under development for the treatment of proliferating superficial infantile hemangiomas. Auson previously completed a three-arm Phase II/III trial of 168 patients that showed efficacy results for ASN-001. In the study, 56% of patients applying ASN-001 twice daily and 42% of patients taking ASN-001 three times per day showed elimination or near-elimination of their infantile hemangiomas at week 24, compared with 15% in the placebo group. Eton will run a bioavailability bridging study for ASN-001 and intends to submit the New Drug Application (NDA) upon completion of the study in the second half of 2027. “Our acquisition of HEMANGEOL ® (propranolol hydrochloride) oral solution gave us a unique view into the infantile hemangioma treatment landscape. We consistently observed that physicians rely on HEMANGEOL for patients requiring systemic therapy, while a much larger group of moderate patients are treated with ophthalmic timolol products used off-label because no FDA-approved topical option exists. ASN-001 is designed specifically for this population, making it highly complementary to HEMANGEOL and positioning Eton to potentially address the full spectrum of infantile hemangioma treatment. We’re highly committed to investing in the development of new therapies and are excited to collaborate with Auson to bring ASN-001 to patients as quickly as possible,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “This transaction adds yet another high-value, late-stage candidate to our pipeline, and showcases Eton’s unique ability to effectively enter new therapeutic areas and leverage its commercial infrastructure and relationships to quickly expand within a specialty,” concluded Brynjelsen. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Infantile hemangiomas are non-cancerous vascular tumors that typically appear in the first days or weeks of a newborn’s life. In severe cases, infantile hemangiomas can lead to serious complications including loss of vision, trouble breathing, or physical deformities, and require intervention with systemic therapy. They affect more than 100,000 infants annually in the United States and exist across a broad spectrum of severity. HEMANGEOL is the established standard of care for proliferating infantile hemangiomas requiring systemic therapy, representing an estimated 10,000 to 15,000 patients annually. For the substantially larger population of moderate infantile hemangiomas, physicians frequently prescribe ophthalmic timolol products to be used off-label. These products were not developed or approved for infantile hemangiomas and present practical limitations, including variable dosing, formulation challenges, and the absence of FDA-approved labeling for this indication. The Company estimates that more than 10,000 patients annually currently use timolol ophthalmic products off-label to treat infantile hemangiomas, and the total market opportunity for an FDA-approved product is estimated to be 20,000 to 30,000 patients. If approved, ASN-001 would become the first FDA-approved topical therapy for infantile hemangiomas and complement HEMANGEOL by serving a different segment of the disease spectrum. ASN-001 is expected to be prescribed by the same healthcare professionals as HEMANGEOL, allowing Eton to leverage its existing pediatric dermatology commercial infrastructure and its strong relationships with infantile hemangioma thought leaders and vascular anomaly centers. ASN-001 has patent protection through 2044 and an additional patent application pending with the United States Patent and Trademark Office. IMPORTANT SAFETY INFORMATION FOR HEMANGEOL USE HEMANGEOL (propranolol hydrochloride) oral solution is a prescription medicine used to treat proliferating infantile hemangioma (a type of birthmark) requiring treatment throughout the body. Who should NOT take HEMANGEOL? Do not give HEMANGEOL to your child if they: Were born early and are less than 5 weeks corrected age Weigh less than 4.5 lbs Have asthma or a history of breathing problems (bronchospasm) Have certain heart conditions (such as slow heart rate, heart block, or heart failure) Have very low blood pressure Have high blood pressure caused by a tumor on the adrenal gland, called “pheochromocytoma” Are allergic to propranolol or any of the ingredients in HEMANGEOL IMPORTANT SAFETY INFORMATION HEMANGEOL may cause serious side effects, including: Low blood sugar (hypoglycemia), which can be serious and may lead to seizures, loss of consciousness, or even death. This is more likely if your child is not eating well, is vomiting, or is sick. Always give HEMANGEOL during or right after feeding. Do not give a dose if your child is not eating. Signs of low blood sugar may include pale skin, sweating, irritability, unusual sleepiness, or seizures. Bradycardia and hypotension. HEMANGEOL may slow your child’s heart rate or lower their blood pressure. Call your healthcare provider if your child seems unusually tired, dizzy, faints, or has pale or cold skin. Bronchospasm. HEMANGEOL can cause breathing problems or make them worse. Get medical help right away if your child has wheezing or trouble breathing. Cardiac failure. In certain patients with preexisting heart conditions, HEMANGEOL can worsen the heart’s ability to pump blood. Increased risk of stroke. HEMANGEOL may increase the risk of stroke in children with certain blood vessel conditions (such as PHACE syndrome). Your healthcare provider may check for these conditions, especially in infants with large facial hemangiomas, before starting treatment. Hypersensitivity. HEMANGEOL may make severe allergic reactions worse and may make it harder to treat these reactions with epinephrine (a medicine used in emergencies). What are the most common side effects of HEMANGEOL? The most common side effects include trouble sleeping, respiratory infections (such as colds or bronchitis), diarrhea, and vomiting. Drug interactions Tell your healthcare provider about all medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect how HEMANGEOL works or increase the risk of side effects, including medicines that affect how the body processes propranolol or increase the risk of low blood sugar (such as corticosteroids). You are encouraged to report negative side effects of prescription drugs by contacting Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at or call 1-800-FDA-1088. Please see full Prescribing Information for more information. About Eton Pharmaceuticals Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has eleven commercial rare disease products: KHINDIVI ® , INCRELEX ® , ALKINDI SPRINKLE ® , DESMODA™, GALZIN ® , HEMANGEOL ® , PKU GOLIKE ® , IMPAVIDO ® , Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has four additional product candidates in late-stage development: Amglidia ® , ET-700, ET-800 and ZENEO ® hydrocortisone autoinjector. For more information, please visit our website at . Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Relations: Lisa M. Wilson, In-Site Communications, Inc. T: 212-452-2793 E: lwilson@insitecony.com