UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41294 Onconetix, Inc. (Exact name of registrant as specified in its charter) | Delaware | 83-2262816 | | --- | --- | | (State or ...

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) (Former name, former address and former fiscal year, if changed since last report) Securities registered pursuant to Section 12(b) of the Act: For the transition period from to Commission Fi ...

[Executive Summary & Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Highlights) [Key Operational and Financial Highlights](index=1&type=section&id=Key%20Operational%20and%20Financial%20Highlights) Lexeo Therapeutics reported significant operational progress in Q2 2025, including Breakthrough Therapy designation for LX2006, selection for the FDA's CDRP program, continued dosing in the LX2020 trial, and a new strategic partnership for non-viral RNA therapeutics. Financially, the company secured an $80 million equity financing, extending its operational runway into 2028, and appointed Louis Tamayo as Chief Financial Officer - **Breakthrough Therapy designation** granted for LX2006 based on interim Phase I/II data demonstrating clinically meaningful improvements in cardiac and neurologic measures of Friedreich ataxia[1](index=1&type=chunk)[3](index=3&type=chunk) - LX2006 selected for FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot (**CDRP program**) to facilitate CMC registrational readiness and support faster patient access[1](index=1&type=chunk)[4](index=4&type=chunk) - **Eight participants** dosed in Phase I/II clinical trial (HEROIC-PKP2) of LX2020 for PKP2-ACM; interim clinical data update on track for second half of 2025[1](index=1&type=chunk)[4](index=4&type=chunk) - **Strategic partnership** announced with Perceptive Xontogeny Venture Funds and venBio Partners to advance non-viral, RNA-based therapeutics for genetic cardiac diseases[1](index=1&type=chunk)[6](index=6&type=chunk) - **$80 million equity financing** closed to support development of clinical stage pipeline[1](index=1&type=chunk)[6](index=6&type=chunk) - Cash, cash equivalents and investments in marketable securities of **$152.5 million** expected to provide operational runway into **2028**[1](index=1&type=chunk)[6](index=6&type=chunk) - **Louis Tamayo** appointed **Chief Financial Officer**[1](index=1&type=chunk)[6](index=6&type=chunk) [Business and Program Updates](index=1&type=section&id=Business%20and%20Program%20Updates) [LX2006 in Friedreich Ataxia (FA)](index=1&type=section&id=LX2006%20in%20Friedreich%20Ataxia%20(FA)) LX2006 received FDA Breakthrough Therapy designation and was selected for the CDRP program, accelerating its path to a registrational study expected to begin in early 2026 with potential efficacy data in 2027. The CLARITY-FA natural history study is enrolling to serve as an external control, and LX2006 continues to demonstrate a generally well-tolerated safety profile - In July 2025, LX2006 received **FDA Breakthrough Therapy designation** based on interim clinical data demonstrating clinically meaningful improvements in cardiac and neurologic measures of FA[4](index=4&type=chunk) - LX2006 selected for FDA Chemistry, Manufacturing, and Controls (CMC) Development Readiness Pilot (**CDRP program**) to accelerate CMC registrational readiness[4](index=4&type=chunk) - Lexeo expects final alignment with FDA on the LX2006 registrational study in **late Q3 to early Q4 2025**, with initiation planned for **early 2026** and potential efficacy readout in **2027**[4](index=4&type=chunk) - The **CLARITY-FA natural history study** is currently enrolling and is expected to serve as a concurrent external control arm for the planned registrational study[4](index=4&type=chunk) - LX2006 continues to be **generally well tolerated** with no clinically significant complement activation and no new treatment-related serious adverse events[4](index=4&type=chunk) [LX2020 in PKP2-ACM](index=1&type=section&id=LX2020%20in%20PKP2-ACM) Eight participants have been dosed in the HEROIC-PKP2 Phase I/II clinical trial for LX2020, across three cohorts, with the high-dose Cohort 3 still enrolling. The therapy has shown a generally well-tolerated safety profile, and interim clinical data is anticipated in the second half of 2025 - **Eight participants** have been dosed to date in the HEROIC-PKP2 Phase I/II clinical trial for LX2020, including **three in Cohort 1** (low dose), **three in Cohort 2** (high dose), and **two in dose-expansion Cohort 3** (high dose)[4](index=4&type=chunk) - **Cohort 3** is still enrolling, and up to **two additional participants** may be dosed in this cohort[4](index=4&type=chunk) - LX2020 has been **generally well tolerated** with no clinically significant complement activation and no treatment-related serious adverse events to date across all dose cohorts[4](index=4&type=chunk) - Lexeo expects to share an interim clinical data update in the **second half of 2025**[4](index=4&type=chunk) [Strategic Developments & Corporate Updates](index=2&type=section&id=Strategic%20Developments%20%26%20Corporate%20Updates) [Equity Financing](index=2&type=section&id=Equity%20Financing) Lexeo closed an $80 million equity financing in May 2025, which is expected to fund operations into 2028, covering a potential efficacy readout for the LX2006 registrational study in 2027 - Closed an **$80 million equity financing** in **May 2025** to further advance development of its clinical stage genetic medicine candidates[6](index=6&type=chunk) - Lexeo anticipates that current cash, cash equivalents and marketable securities will be sufficient to fund operating and capital expenditures into **2028**, through a potential efficacy readout for the registrational study of LX2006 in **2027**[6](index=6&type=chunk) [Research Collaboration](index=2&type=section&id=Research%20Collaboration) In June 2025, Lexeo announced a strategic partnership with Perceptive Xontogeny Venture Funds and venBio Partners to develop non-viral RNA-based therapies for genetic cardiac diseases. The partners will contribute up to $40 million in financing to a new entity, with Lexeo contributing expertise and intellectual property for an equity position, milestone payments, royalties, and opt-in rights - **Strategic partnership** announced in **June 2025** with Perceptive Xontogeny Venture Funds and venBio Partners to develop therapies for genetic cardiac diseases utilizing a novel non-viral RNA platform[6](index=6&type=chunk) - PXV Funds and venBio will contribute up to **$40 million** in private equity financing to a new entity[6](index=6&type=chunk) - Lexeo is contributing expertise and know-how in cardiac genetic medicines, preclinical intellectual property and technology to the partnership, with a **double-digit percentage equity position** in the new entity at transaction close alongside entitlement to future milestone payments, royalties, and opt-in rights[6](index=6&type=chunk) [New Leadership Appointment](index=2&type=section&id=New%20Leadership%20Appointment) Louis Tamayo was appointed Chief Financial Officer, succeeding Kyle Rasbach. Mr. Tamayo brings extensive commercial finance experience from Siemens Healthineers AG, Becton, Dickinson and Company, and Pfizer, and will support Lexeo's late-stage clinical and commercialization plans - **Louis Tamayo** has been appointed **Chief Financial Officer**, succeeding Kyle Rasbach[6](index=6&type=chunk) - Mr. Tamayo will support Lexeo's **late-stage clinical and commercialization plans** as LX2006 development accelerates and LX2020 development continues, alongside strategic planning, portfolio management, capital allocation, and other financial operations[6](index=6&type=chunk) - Mr. Tamayo brings extensive commercial finance experience, having previously served as Senior Vice President at Siemens Healthineers AG, and held roles at Becton, Dickinson and Company and Pfizer[6](index=6&type=chunk) [Recent Data Presentations](index=2&type=section&id=Recent%20Data%20Presentations) Lexeo presented new data at ASGCT on AAV manufacturing optimization via its Sf9-baculovirus process, demonstrating high purity, potency, improved scalability, and reduced cost. The company also presented data at the Global Cell and Gene Therapy Summit reviewing the favorable complement profile of AAVrh10, with no clinically significant complement activation observed in three gene therapy studies - Lexeo presented new data at the 28th American Society of Gene & Cell Therapy (ASGCT) Annual Meeting on AAV manufacturing optimization via the Company's Sf9-baculovirus process, showing **high purity and potency** of yields with **improved scalability** and **reduced cost**[6](index=6&type=chunk) - Lexeo also presented data at the Global Cell and Gene Therapy Summit reviewing the **favorable complement profile** of AAVrh10 based on clinical monitoring experience across three gene therapy studies in FA and PKP2, with **no clinically significant events** related to complement activation observed[6](index=6&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) [Financial Summary](index=2&type=section&id=Financial%20Summary) For the three months ended June 30, 2025, Lexeo reported a net loss of $26.1 million, or $0.60 per share, compared to a net loss of $21.2 million, or $0.64 per share, in the prior year period. Research and development expenses decreased slightly, while general and administrative expenses significantly increased. The company's cash position as of June 30, 2025, was $152.5 million, projected to fund operations into 2028 Key Financial Metrics (Three Months Ended June 30) | Financial Metric (in thousands) | 2025 | 2024 | Change (YoY) | | :-------------------------------------------- | :--- | :--- | :----------- | | Research and Development Expenses | $14,721 | $16,560 | -$1,839 | | General and Administrative Expenses | $15,967 | $6,990 | +$8,977 | | Total Operating Expenses | $30,688 | $23,550 | +$7,138 | | Operating Loss | $(30,688) | $(23,550) | -$(7,138) | | Net Loss | $(26,103) | $(21,238) | -$(4,865) | | Net Loss per Common Share (basic and diluted) | $(0.60) | $(0.64) | +$0.04 | - Net loss increased to **$26.1 million** in Q2 2025 from **$21.2 million** in Q2 2024[6](index=6&type=chunk)[9](index=9&type=chunk) - General and Administrative expenses significantly increased to **$16.0 million** in Q2 2025 from **$7.0 million** in Q2 2024[6](index=6&type=chunk)[9](index=9&type=chunk) - Cash, cash equivalents, and investments in marketable securities were **$152.5 million** as of June 30, 2025, which Lexeo believes will be sufficient to fund operations into **2028**[6](index=6&type=chunk)[10](index=10&type=chunk) [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) The condensed statements of operations show a net loss of $26.1 million for Q2 2025 and $58.8 million for the six months ended June 30, 2025. Total operating expenses increased significantly year-over-year for both the quarter and year-to-date periods, primarily driven by general and administrative costs Condensed Statements of Operations (Unaudited, in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $14,721 | $16,560 | $31,892 | $32,302 | | General and administrative | $15,967 | $6,990 | $32,601 | $14,539 | | Total operating expenses | $30,688 | $23,550 | $64,493 | $46,841 | | Operating loss | $(30,688) | $(23,550) | $(64,493) | $(46,841) | | Net loss | $(26,103) | $(21,238) | $(58,759) | $(42,920) | | Net loss per common share, basic and diluted | $(0.60) | $(0.64) | $(1.53) | $(1.41) | | Weighted average number of shares outstanding | 43,573,628 | 33,001,946 | 38,372,704 | 30,490,892 | - Total operating expenses for the three months ended June 30, 2025, were **$30.7 million**, an increase from **$23.6 million** in the prior year period[9](index=9&type=chunk) - Total operating expenses for the six months ended June 30, 2025, were **$64.5 million**, up from **$46.8 million** in the prior year period[9](index=9&type=chunk) [Condensed Balance Sheet Data](index=4&type=section&id=Condensed%20Balance%20Sheet%20Data) As of June 30, 2025, Lexeo's cash, cash equivalents, and investments in U.S. Treasury securities increased to $152.5 million from $128.5 million at December 31, 2024. Total assets also increased, while total liabilities saw a moderate rise Condensed Balance Sheet Data (Unaudited, in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | | :------------------------------------------------ | :------------ | :---------------- | :----- | | Cash, cash equivalents, and investments in U.S. Treasury securities | $152,506 | $128,530 | +$23,976 | | Total assets | $176,068 | $146,942 | +$29,126 | | Total liabilities | $37,850 | $30,100 | +$7,750 | | Total stockholders' equity | $138,218 | $116,842 | +$21,376 | - Cash, cash equivalents, and investments in U.S. Treasury securities increased by **$23.98 million** from December 31, 2024, to June 30, 2025[10](index=10&type=chunk) [About Lexeo Therapeutics](index=2&type=section&id=About%20Lexeo%20Therapeutics) [Company Overview](index=2&type=section&id=Company%20Overview) Lexeo Therapeutics is a New York City-based clinical stage genetic medicine company focused on developing novel treatments for cardiovascular diseases by targeting underlying genetic causes. Its pipeline includes LX2006 for Friedreich ataxia cardiomyopathy and LX2020 for PKP2 arrhythmogenic cardiomyopathy - Lexeo Therapeutics is a New York City-based, **clinical stage genetic medicine company** dedicated to reshaping heart health by applying pioneering science to fundamentally change how cardiovascular diseases are treated[5](index=5&type=chunk) - The Company is advancing a portfolio of therapeutic candidates that take aim at the underlying genetic causes of conditions, including **LX2006** in **Friedreich ataxia cardiomyopathy (FA)** and **LX2020** in **plakophilin-2 (PKP2) arrhythmogenic cardiomyopathy**[5](index=5&type=chunk) [Legal & Contact Information](index=3&type=section&id=Legal%20%26%20Contact%20Information) [Cautionary Note Regarding Forward-Looking Statements](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) The report contains forward-looking statements subject to various risks and uncertainties, including those related to clinical trials, regulatory approvals, and financial resources. Lexeo advises against undue reliance on these statements and disclaims any obligation to update them, except as required by law, under the protection of the Private Securities Litigation Reform Act of 1995 - Certain statements in this press release may constitute **'forward-looking statements'** regarding Lexeo's product candidates, clinical trials, regulatory developments, and financial condition[7](index=7&type=chunk) - These forward-looking statements are subject to various risks and uncertainties, including those set forth in Lexeo's SEC filings, and actual results could be materially different[7](index=7&type=chunk) - Lexeo claims the protection of the Safe Harbor contained in the **Private Securities Litigation Reform Act of 1995** for forward-looking statements and expressly disclaims any obligation to update or alter any statements, except as required by law[7](index=7&type=chunk) [Media and Investor Contacts](index=3&type=section&id=Media%20and%20Investor%20Contacts) Contact information is provided for media inquiries (Media@lexeotx.com) and investor relations (Carlo Tanzi, Ph.D., ctanzi@kendallir.com) - Media inquiries can be directed to **Media@lexeotx.com**[8](index=8&type=chunk) - Investor inquiries can be directed to **Carlo Tanzi, Ph.D.**, at **ctanzi@kendallir.com**[8](index=8&type=chunk)

[PART I - FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for June 30, 2025, reflect significant financial improvement, driven by a $152.4 million PRV gain and resulting in $96.8 million net income [Condensed Consolidated Balance Sheets](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets significantly increased to $246.2 million, primarily due to a rise in cash and cash equivalents, leading to positive stockholders' equity Balance Sheet Highlights ($ in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $163,535 | $23,357 | | Total current assets | $232,262 | $100,853 | | Total assets | $246,233 | $108,931 | | **Liabilities & Equity** | | | | Total liabilities | $82,657 | $64,900 | | Total stockholders' equity | $163,576 | $44,031 | | Total liabilities and stockholders' equity | $246,233 | $108,931 | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20%28Loss%29) For the six months ended June 30, 2025, the company achieved a net income of $96.8 million, a significant turnaround from a $24.2 million loss in 2024, primarily due to a $152.4 million PRV gain Income Statement Highlights ($ in thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | License and other revenues | $400 | $0 | | Research and development | $15,884 | $16,425 | | Selling, general and administrative | $26,935 | $15,769 | | Loss from operations | ($42,519) | ($32,194) | | Gain from sale of priority review voucher, net | $152,366 | $0 | | Net income (loss) | $96,804 | ($24,172) | | Basic income (loss) per common share | $1.89 | ($0.72) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash increased by $140.2 million to $163.9 million, driven by $160.1 million from investing activities, primarily the PRV sale Cash Flow Summary ($ in thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($37,186) | ($27,222) | | Net cash provided by (used in) investing activities | $160,101 | ($51,949) | | Net cash provided by financing activities | $17,263 | $99,124 | | Net increase in cash, cash equivalents and restricted cash | $140,178 | $19,953 | | Cash, cash equivalents and restricted cash at end of period | $163,873 | $34,764 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's transition to a commercial-stage entity, highlighting the $152.4 million PRV sale, initial license revenue, inventory capitalization, and sufficient capital for the next 12 months - On April 28, 2025, the FDA approved ZEVASKYN™ for the treatment of wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB), marking the company's transition to a commercial-stage biopharmaceutical company[25](index=25&type=chunk) - Following FDA approval, the company began capitalizing inventory costs related to ZEVASKYN™ As of June 30, 2025, inventory consisted of **$2.7 million** in raw materials[32](index=32&type=chunk)[13](index=13&type=chunk) - In June 2025, a third party exercised an option to license certain of the company's AAV capsids, resulting in **$0.4 million** of license revenue The agreement includes potential future milestone and royalty payments[97](index=97&type=chunk)[99](index=99&type=chunk) - The company sold a Priority Review Voucher (PRV) in June 2025, receiving gross proceeds of **$155.0 million** and recognizing a net gain of **$152.4 million** after transaction costs[118](index=118&type=chunk) - The company recorded an income tax expense of **$15.5 million** for the first half of 2025, driven by the pre-tax income from the PRV sale The company is assessing the impact of new tax legislation which may reduce its 2025 tax liability[114](index=114&type=chunk)[117](index=117&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's transition to a commercial-stage entity, highlighting the $155.0 million PRV sale, ZEVASKYN™ commercial launch preparations, and sufficient liquidity for the next 12 months - Abeona is now a commercial-stage company after the FDA approved ZEVASKYN™ on April 28, 2025, for treating wounds in RDEB patients[121](index=121&type=chunk) - The company sold its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of **$155.0 million**, with the transaction closing on June 27, 2025[122](index=122&type=chunk) - Commercial launch of ZEVASKYN™ is underway, with the first Qualified Treatment Center (QTC) activated in May 2025 and treatments expected to start in Q3 2025[123](index=123&type=chunk) - As of June 30, 2025, cash resources were **$225.9 million**, which management believes is sufficient to fund operations for at least the next 12 months[167](index=167&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) For Q2 2025, net income reached $108.8 million, primarily due to the $152.4 million PRV gain, while R&D decreased 36% and SG&A increased 98% due to commercialization efforts Financial Performance ($ in thousands) | Item | Q2 2025 | Q2 2024 | Change (%) | | :--- | :--- | :--- | :--- | | License and other revenues | $400 | $0 | 100% | | Research and development | $5,943 | $9,218 | (36)% | | Selling, general and administrative | $17,149 | $8,646 | 98% | | Gain from sale of PRV, net | $152,366 | $0 | 100% | | Net income | $108,833 | $7,406 | 1,370% | - The decrease in Q2 R&D spending was primarily due to **$1.4 million** of costs capitalized into inventory and **$4.9 million** of production costs reclassified as SG&A following ZEVASKYN™'s FDA approval[132](index=132&type=chunk) - The increase in Q2 SG&A expenses was driven by approximately **$4.9 million** in reclassified production costs and a **$3.7 million** increase in salaries, stock-based compensation, and other professional fees related to commercial launch preparations[134](index=134&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity significantly improved to $225.9 million as of June 30, 2025, primarily from the $155.0 million PRV sale, with current capital sufficient for the next 12 months Cash Flow Summary ($ in thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($37,186) | ($27,222) | | Net cash provided by (used in) investing activities | $160,101 | ($51,949) | | Net cash provided by financing activities | $17,263 | $99,124 | - The company's principal source of liquidity is its **$225.9 million** in cash resources as of June 30, 2025, which includes the proceeds from the PRV sale[167](index=167&type=chunk) - During the first six months of 2025, the company raised **$17.3 million** in net proceeds from selling **3,510,889 shares** under its ATM Agreement As of June 30, 2025, up to **$51.5 million** remains available for sale under the agreement[168](index=168&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable for the current reporting period - The company has indicated that quantitative and qualitative disclosures about market risk are not applicable[178](index=178&type=chunk) [Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - The Chief Executive Officer and Chief Financial Officer concluded that the company's Disclosure Controls and Procedures were effective as of June 30, 2025[180](index=180&type=chunk) - No changes occurred during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[181](index=181&type=chunk) [PART II - OTHER INFORMATION](index=40&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the current period - There are no legal proceedings to report[184](index=184&type=chunk) [Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) The company highlights new risks related to commercializing its first product, ZEVASKYN™, including revenue generation challenges, NOL limitations, and potential government agency disruptions - As a newly commercial-stage company with its first approved product, ZEVASKYN™, it is difficult to assess future viability, and the company may not be able to sustain profitability[186](index=186&type=chunk) - The company's ability to generate significant revenue depends on the successful commercialization of ZEVASKYN™, which involves overcoming challenges in market acceptance, reimbursement, and patient identification[187](index=187&type=chunk)[188](index=188&type=chunk) - The company's ability to use its **$416.1 million** in U.S. federal net operating loss (NOL) carryforwards may be materially limited due to multiple historical ownership changes under Section 382, with a full analysis expected by year-end 2025[191](index=191&type=chunk)[192](index=192&type=chunk) - Disruptions at the FDA and other government agencies, such as those caused by funding shortages, hiring freezes, or reorganization, could delay or prevent product approvals and commercialization, negatively impacting the business[194](index=194&type=chunk) [Unregistered Sale of Equity Securities and Use of Proceeds](index=42&type=section&id=Item%202.%20Unregistered%20Sale%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q2 2025, the company reported the surrender of **885** common shares at **$6.24** per share to satisfy tax withholding obligations from restricted stock vesting Shares Surrendered for Tax Withholding | Period | Shares Purchased | Average Price Paid per Share ($) | | :--- | :--- | :--- | | June 1, 2025 - June 30, 2025 | 885 | $6.24 | | **Total Q2 2025** | **885** | **$6.24** | - The shares were surrendered to the company to cover tax withholding obligations from the vesting of restricted stock awards[199](index=199&type=chunk) [Other Information](index=43&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q2 2025 - No directors or executive officers adopted, modified, or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the second quarter of 2025[201](index=201&type=chunk) [Exhibits](index=43&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including the PRV Asset Purchase Agreement, officer certifications, and interactive data files - Key exhibits filed include the Priority Review Voucher Asset Purchase Agreement dated May 9, 2025, and certifications from the Principal Executive Officer and Principal Financial Officer[207](index=207&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 001-39995 ADVANCED FLOWER CAPITAL INC. (Exact name of registrant as specified in its charter) Maryland 85-1807125 (State or ...

Intend to Pursue an NDA Submission to the U.S. FDA under Accelerated Approval Pathway for Iopofosine I 131 for the Treatment of Waldenstrom Macroglobulinemia (WM) Subject to Suf icient Funding and Once the Confirmatory Trial is Underway Continue to Work with the EMA Toward a Potential Submission of Iopofosine I 131 for Conditional Approval in the EU; Decision expected late 3Q early 4Q 2025 Exhibit 99.1 Cellectar Biosciences Reports Second Quarter 2025 Financial Results and Provides a Corporate Update On tra ...

Financial Transactions - Abeona Therapeutics completed the sale of its Rare Pediatric Disease Priority Review Voucher for gross proceeds of $155 million on June 27, 2025[6]. - As of June 30, 2025, the company's unaudited cash, cash equivalents, restricted cash, and short-term investments totaled approximately $225 million, including net proceeds from the asset sale[8][10]. - The asset sale was executed under a purchase agreement dated May 9, 2025, specifically for the PRV[6]. - The press release regarding the asset sale was issued on July 2, 2025, highlighting the completion of the transaction[8]. Regulatory and Compliance - The Priority Review Voucher was awarded to the company on April 28, 2025, following the approval of its biologics license application for ZEVASKYN™[5]. - The financial information provided is preliminary and subject to completion of the company's financial closing procedures[11]. - The independent registered public accounting firm has not reviewed the preliminary estimates and does not provide any assurance regarding them[11]. - The company plans to file the full text of the PRV Asset Purchase Agreement with its Quarterly Report for the three months ended June 30, 2025[7]. Strategic Initiatives - The asset sale is part of the company's strategy to enhance its financial position and support future growth initiatives[6]. - The company is classified as an emerging growth company under the Securities Act of 1933[4].

[SpartanNash Second Quarter Fiscal 2025 Results](index=1&type=section&id=SpartanNash%20Second%20Quarter%20Fiscal%202025%20Results) [Financial and Operational Highlights](index=1&type=section&id=Financial%20and%20Operational%20Highlights) SpartanNash's Q2 FY2025 net sales rose 1.8% to $2.27 billion, net earnings fell to $6.2 million, but Adjusted EBITDA increased to $68.7 million Q2 Fiscal 2025 Key Financial Metrics | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Net Sales (Billions $) | $2.27 | $2.23 | +1.8% | | Net Earnings (Millions $) | $6.2 | $11.5 | -46.1% | | Diluted EPS ($) | $0.18 | $0.34 | -47.1% | | Adjusted EPS ($) | $0.54 | $0.59 | -8.5% | | Adjusted EBITDA (Millions $) | $68.7 | $64.5 | +6.5% | - The ratio of net long-term debt to adjusted EBITDA improved sequentially to **2.7x** from **2.9x** at the end of the first quarter[6](index=6&type=chunk) - Capital expenditures and IT capital for the quarter amounted to **$56.2 million**, a decrease from **$73.4 million** in the prior year's quarter[6](index=6&type=chunk) - The company returned **$15.5 million** to shareholders through dividends during the quarter[6](index=6&type=chunk) [C&S Wholesale Grocers Transaction](index=1&type=section&id=C%26S%20Wholesale%20Grocers%20Transaction) SpartanNash agreed to be acquired by C&S Wholesale Grocers for $26.90 per share, valuing the deal at $1.77 billion, with closing expected late 2025 - On June 22, 2025, SpartanNash agreed to be acquired by C&S Wholesale Grocers in an all-cash transaction[5](index=5&type=chunk) Transaction Details | Metric | Value | | :--- | :--- | | Purchase Price per Share ($) | $26.90 | | Total Consideration (Billions $) | $1.77 (incl. net debt) | | Premium to June 20, 2025 Close (%) | 52.5% | | Premium to 30-day VWAP (%) | 42.0% | - The transaction is expected to close in late 2025, subject to customary closing conditions including shareholder and regulatory approvals[7](index=7&type=chunk) [Segment Performance](index=1&type=section&id=Segment%20Performance) Retail net sales grew 12.8% to $762.9 million from acquisitions, while Wholesale net sales fell 3.0% to $1.51 billion due to volume declines Q2 2025 Segment Results (vs Q2 2024) | Segment | Net Sales ($) | % Change | Operating Earnings ($) | % Change | | :--- | :--- | :--- | :--- | :--- | | Wholesale | $1.51B | -3.0% | $18.0M | -18.3% | | Retail | $762.9M | +12.8% | $0.1M | -97.9% | - Wholesale sales decline was driven by reduced case volumes in national accounts and the elimination of intercompany sales to newly acquired stores, partially offset by higher military channel sales[6](index=6&type=chunk) - Retail sales growth was due to incremental sales from recently acquired stores, however, retail comparable store sales decreased by **0.5%** due to lower unit volumes[6](index=6&type=chunk) [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) This section presents unaudited condensed consolidated financial statements, including earnings, balance sheets, and cash flows for Q2 and year-to-date fiscal 2025 [Condensed Consolidated Statements of Earnings](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Earnings) Q2 2025 net sales rose to $2.27 billion, but increased operating expenses led to lower operating earnings of $18.1 million and net earnings of $6.2 million Q2 2025 Statement of Earnings Highlights (in thousands) | Line Item | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net sales | $2,271,145 | $2,230,756 | | Gross profit | $382,622 | $353,003 | | Total operating expenses | $364,498 | $326,877 | | Operating earnings | $18,124 | $26,126 | | Net earnings | $6,190 | $11,489 | | Diluted EPS | $0.18 | $0.34 | [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of July 12, 2025, total assets were $2.56 billion, slightly down from fiscal 2024, with liabilities decreasing and shareholders' equity stable Balance Sheet Highlights (in thousands) | Line Item | July 12, 2025 | Dec 28, 2024 | | :--- | :--- | :--- | | Total current assets | $1,087,985 | $1,091,811 | | Total assets | $2,557,509 | $2,602,296 | | Total current liabilities | $693,550 | $695,239 | | Total long-term debt | $713,971 | $740,969 | | Total shareholders' equity | $741,824 | $743,490 | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the 28 weeks ended July 12, 2025, net cash from operating activities decreased to $112.6 million, resulting in a net cash increase of $3.9 million for the period Year-to-Date Cash Flow Summary (in thousands) | Cash Flow Activity | 28 Weeks Ended Jul 12, 2025 | 28 Weeks Ended Jul 13, 2024 | | :--- | :--- | :--- | | Net cash from operating activities | $112,563 | $132,098 | | Net cash used in investing activities | $(59,445) | $(79,495) | | Net cash used in financing activities | $(49,184) | $(45,325) | | Net increase in cash | $3,934 | $7,278 | [Non-GAAP Financial Measures and Reconciliations](index=6&type=section&id=Non-GAAP%20Financial%20Measures%20and%20Reconciliations) This section details non-GAAP financial measures like Adjusted EBITDA and EPS, used by management to assess performance by excluding non-operational items, with reconciliations - The company provides non-GAAP measures such as adjusted EPS, net long-term debt, and adjusted EBITDA, which management believes provide useful supplemental information for investors to evaluate performance[24](index=24&type=chunk) - Adjustments to derive non-GAAP measures exclude items considered "non-operational" or "non-core," such as LIFO expense, organizational realignment costs, acquisition and integration expenses, and restructuring charges[25](index=25&type=chunk)[26](index=26&type=chunk) [Reconciliation of Net Earnings to Adjusted EBITDA (Table 2)](index=7&type=section&id=Reconciliation%20of%20Net%20Earnings%20to%20Adjusted%20EBITDA%20(Table%202)) Q2 2025 Adjusted EBITDA increased to $68.7 million, reconciled from GAAP net earnings of $6.2 million by adding back depreciation, acquisition, and realignment costs Q2 Adjusted EBITDA Reconciliation (in thousands) | Line Item | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net earnings | $6,190 | $11,489 | | Depreciation and amortization | $27,876 | $23,342 | | Acquisition and integration, net | $9,315 | $2,613 | | Organizational realignment, net | $4,330 | $1,369 | | **Adjusted EBITDA** | **$68,695** | **$64,506** | [Reconciliation of Net Earnings to Adjusted EPS (Table 3)](index=8&type=section&id=Reconciliation%20of%20Net%20Earnings%20to%20Adjusted%20EPS%20(Table%203)) Q2 2025 Adjusted EPS was $0.54, adjusted from GAAP diluted EPS of $0.18 by excluding after-tax impacts of acquisition and organizational realignment costs Q2 Adjusted EPS Reconciliation | Line Item | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net earnings (Thousands $) | $6,190 | $11,489 | | Diluted EPS ($) | $0.18 | $0.34 | | Total adjustments, net of taxes (Thousands $) | $12,465 | $8,390 | | **Adjusted earnings (Thousands $)** | **$18,655** | **$19,879** | | **Adjusted EPS ($)** | **$0.54** | **$0.59** | [Reconciliation of Debt to Net Long-Term Debt (Table 4)](index=9&type=section&id=Reconciliation%20of%20Debt%20to%20Net%20Long-Term%20Debt%20(Table%204)) As of July 12, 2025, net long-term debt was $703.4 million, with the leverage ratio improving to 2.7x from 2.9x sequentially Net Long-Term Debt and Leverage Ratio | Metric (in thousands, except ratio) | July 12, 2025 | April 19, 2025 | | :--- | :--- | :--- | | Total debt (Thousands $) | $728,941 | $777,028 | | Less: Cash and cash equivalents (Thousands $) | $(25,504) | $(19,970) | | **Net long-term debt (Thousands $)** | **$703,437** | **$757,058** | | Rolling 52-Weeks Adjusted EBITDA (Thousands $) | $264,644 | $260,455 | | **Net long-term debt to adjusted EBITDA ratio (x)** | **2.7x** | **2.9x** | [Reconciliation of Purchases of Property and Equipment to Capital Expenditures and IT Capital (Table 5)](index=10&type=section&id=Reconciliation%20of%20Purchases%20of%20Property%20and%20Equipment%20to%20Capital%20Expenditures%20and%20IT%20Capital%20(Table%205)) For the 28 weeks ended July 12, 2025, total capital expenditures and IT capital decreased to $56.2 million from $73.4 million in the prior year YTD Capital Expenditures and IT Capital (in thousands) | Line Item | 28 Weeks Ended Jul 12, 2025 | 28 Weeks Ended Jul 13, 2024 | | :--- | :--- | :--- | | Purchases of property and equipment | $51,179 | $67,074 | | Plus: Cloud computing spend | $5,032 | $6,347 | | **Capital expenditures and IT capital** | **$56,211** | **$73,421** | [Forward-Looking Statements and Other Information](index=2&type=section&id=Forward-Looking%20Statements%20and%20Other%20Information) This section outlines risks and uncertainties for forward-looking statements, particularly regarding the C&S transaction, directing investors to SEC filings - Due to the pending transaction with C&S, the company will not host an earnings conference call or provide fiscal 2025 financial guidance[8](index=8&type=chunk) - The report includes forward-looking statements subject to significant risks, including the ability to complete the C&S transaction, competitive pressures, macroeconomic uncertainty, and other factors detailed in SEC filings[10](index=10&type=chunk)[11](index=11&type=chunk) - Investors are urged to read the definitive proxy statement filed with the SEC on July 31, 2025, for important information regarding the proposed transaction[12](index=12&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number 001-41833 Falcon's Beyond Global, Inc. (Exact name of registrant as specified in its charter) | Delaware | 92-0261853 | | ...

Exhibit 99.1 Net income for the second quarter of 2025 was $1.7 million compared to $2.6 million during the quarter ended June 30, 2024. Basic earnings per share and diluted earnings per share were $0.19 and $0.18, respectively, compared to $0.29 and $0.27 for the second quarter of 2024. Elevated merger and acquisition-related expense relating to the Irwin acquisition accounted for most of the decline in net income and earnings per share for the second quarter of 2025 compared to the second quarter of 2024. ...