EXHIBIT 99.1 Cassava Reports Q2 2025 Financials Results and Provides Business Update AUSTIN, Texas, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, "Cassava", the "Company"), a biotechnology company focused on developing novel, investigational treatments for central nervous system (CNS) disorders such as Tuberous Sclerosis Complex (TSC)-related epilepsy, today reported financial results for the second quarter ended June 30, 2025 and provided a business update. Net loss was $44.2 mill ...

[Q2 2025 Performance and Strategic Update](index=1&type=section&id=Q2%202025%20Performance%20and%20Strategic%20Update) [Highlights and Strategy](index=1&type=section&id=Highlights%20and%20Strategy) Edible Garden reported strong Q2 2025 performance, driven by a strategic shift to higher-margin products and e-commerce expansion - The company is executing a portfolio transformation by exiting underperforming, low-margin product lines to focus on **higher-margin, CEA-informed, shelf-stable products**[2](index=2&type=chunk)[3](index=3&type=chunk)[7](index=7&type=chunk) Q2 2025 Key Segment Performance (YoY Growth) | Segment/Product | YoY Growth Rate | | :--- | :--- | | International Vitamin and Supplements Revenue | 66.5% | | Private Label Products | 19.1% | | Non-perishable Unit Sales | ~17% | | Hydroponic Basil | 7.1% | | Potted Herbs | 6.4% | | Wheatgrass | 4.1% | - Acquired the NaturalShrimp aquaculture facility, now Edible Garden Prairie Hills, to enhance R&D, add water treatment patents, and improve distribution efficiency[4](index=4&type=chunk) - Expanded digital footprint by launching the Kick Sports Nutrition line on Amazon, contributing to a **surge in e-commerce sales**[4](index=4&type=chunk) [Q2 2025 Financial Results](index=2&type=section&id=Q2%202025%20Financial%20Results) [Detailed Financial Performance](index=2&type=section&id=Detailed%20Financial%20Performance) Q2 2025 revenue decreased to $3.1 million due to strategic exits, leading to lower gross profit and an increased net loss of $4.0 million Q2 2025 Financial Summary (in millions) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $3.1 | $4.3 | ($1.2) | | Gross Profit | $0.63 | $1.56 | ($0.93) | | SG&A Expenses | $4.2 | $2.7 | $1.5 | | Net Loss | ($4.0) | ($1.9) | ($2.1) | - The decrease in revenue was primarily due to the strategic exit from floral and lettuce categories, accounting for **$741,000 of the decline**[7](index=7&type=chunk) - The increase in SG&A expenses was mainly driven by legal costs for the NaturalShrimp acquisition, Narayan transaction expenses, and franchise tax charges[9](index=9&type=chunk) [Financial Statements](index=3&type=section&id=Financial%20Statements) [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) Total assets increased to **$21.8 million** by June 30, 2025, driven by property and equipment, while total liabilities decreased to **$5.2 million** Selected Balance Sheet Data (in thousands) | Account | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash | $2,821 | $3,530 | | Total Current Assets | $5,889 | $7,377 | | Total Assets | $21,814 | $11,915 | | Total Current Liabilities | $3,954 | $6,210 | | Total Liabilities | $5,222 | $7,821 | | Total Stockholders' Equity (Deficit) | $1,592 | $4,094 | [Consolidated Statements of Operations](index=4&type=section&id=Consolidated%20Statements%20of%20Operations) For Q2 2025, revenue was **$3.1 million**, resulting in a **$3.6 million** operating loss and a **$13.9 million** net loss to common stockholders Statement of Operations Highlights - Three Months Ended June 30 (in thousands, except per-share data) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Revenue | $3,146 | $4,268 | | Gross Profit | $634 | $1,566 | | Loss from Operations | $(3,593) | $(1,182) | | Net Loss | $(4,043) | $(1,932) | | Net Loss Attributable to Common Stockholders | $(13,876) | $(1,932) | | Net Loss per Common Share | $(6.58) | $(30.02) | [Corporate Information](index=2&type=section&id=Corporate%20Information) [Company Profile](index=2&type=section&id=Company%20Profile) Edible Garden leads in controlled environment agriculture (CEA), delivering organic produce to over 5,000 locations using proprietary technology and a diverse product portfolio - The company is a leader in controlled environment agriculture (CEA) with products available in over **5,000 retail locations** across the U.S., Caribbean, and South America[15](index=15&type=chunk) - Owns proprietary GreenThumb 2.0 software and holds multiple U.S. patents related to greenhouse optimization, in-store displays, and advanced aquaculture technologies[16](index=16&type=chunk) - Develops and markets a growing line of nutrition and specialty food products, including Vitamin Way®, Kick. Sports Nutrition, Pulp® sauces, and Pickle Party™ fermented foods[17](index=17&type=chunk) [Conference Call Information](index=2&type=section&id=Conference%20Call%20Information) A conference call was scheduled for 8:00 A.M. Eastern Time to discuss Q2 2025 financial results and corporate developments - A conference call was scheduled for **8:00 A.M. Eastern Time** to discuss the quarterly financial results[12](index=12&type=chunk) - Details for accessing the live webcast and a telephone replay, available through **August 28, 2025**, were provided[13](index=13&type=chunk)[14](index=14&type=chunk)

[Overview and Highlights](index=1&type=section&id=Xilio%20Therapeutics%20Announces%20Pipeline%20and%20Business%20Updates%20and%20Second%20Quarter%202025%20Financial%20Results) The company announced positive Phase 2 data, progress in its T cell engager programs, and a cash runway through Q3 2026 - Announced updated Phase 2 data for vilastobart at ASCO, demonstrating **deep, durable responses** and a **differentiated safety profile** for an anti-CTLA-4 combination therapy[1](index=1&type=chunk) - The company is **on track to nominate its first development candidates** for wholly owned masked T cell engager programs in the second half of 2025[1](index=1&type=chunk) Financial Position and Runway | Metric | Value | | :--- | :--- | | Cash and cash equivalents (as of June 30, 2025) | $121.6 million | | Anticipated cash runway | Through end of Q3 2026 | [Pipeline and Business Updates](index=1&type=section&id=Pipeline%20and%20Business%20Updates) The company reports progress across its key pipeline assets, including vilastobart, XTX301, XTX501, and masked T cell engagers [Vilastobart (anti-CTLA-4)](index=1&type=section&id=Vilastobart%3A%20tumor-activated%2C%20Fc-enhanced%2C%20high%20af%20inity%20binding%20anti-CTLA-4) Phase 2 data for vilastobart showed a 26% objective response rate in certain CRC patients with a well-tolerated safety profile - Updated Phase 2 data presented at ASCO 2025 demonstrated a preliminary **26% objective response rate (ORR)** in heavily pre-treated metastatic MSS CRC patients without liver metastases[3](index=3&type=chunk) - The therapy showed a **differentiated and well-tolerated safety profile**, with a low incidence of colitis and other immune-related adverse events[3](index=3&type=chunk) - Xilio is actively engaging with strategic partners for potential opportunities to **accelerate and expand the development** of vilastobart[3](index=3&type=chunk) [XTX301 (IL-12)](index=2&type=section&id=XTX301%3A%20tumor-activated%20IL-12) The company is advancing its tumor-activated IL-12, XTX301, under an exclusive license agreement with Gilead - Xilio has an **exclusive license agreement with Gilead Sciences** for its tumor-activated IL-12 program, including XTX301[4](index=4&type=chunk) - **Enrollment in the Phase 1A monotherapy dose escalation** portion of the clinical trial has been completed, with patient evaluation ongoing[4](index=4&type=chunk) [XTX501 (PD-1/IL-2 bispecific)](index=2&type=section&id=XTX501%3A%20masked%20PD-1%2FIL-2%20bispecific) The novel tumor-activated bispecific XTX501 is progressing through IND-enabling studies, with an IND submission planned for mid-2026 - XTX501 is currently **advancing in investigational new drug (IND)-enabling studies**[5](index=5&type=chunk) - The company plans to **submit an IND application for XTX501 in the middle of 2026**[5](index=5&type=chunk) [Masked T Cell Engager Programs](index=2&type=section&id=Masked%20T%20Cell%20Engager%20Programs) The company is developing multiple preclinical masked T cell engager programs using its proprietary ATACR and SEECR formats - The pipeline includes wholly owned programs targeting **PSMA, CLDN18.2, and STEAP1**, plus a collaboration with AbbVie[6](index=6&type=chunk) - The programs utilize two proprietary formats: the bispecific **ATACR** (activated cell engager) and the tri-specific **SEECR** (selective effector-enhanced cell engager)[7](index=7&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) The company provided a development candidate timeline, closed a public offering, and appointed a new board member Development Candidate Nomination Timeline | Program | Format | Anticipated Nomination | | :--- | :--- | :--- | | PSMA | ATACR | Q3 2025 | | CLDN18.2 | ATACR | Q4 2025 | | STEAP1 | SEECR | H1 2026 | - In June 2025, Xilio closed a follow-on public offering, receiving initial gross proceeds of approximately **$50.0 million**, with potential for up to an additional **$100.0 million** if all associated warrants are exercised[9](index=9&type=chunk) - Akintunde (Tunde) Bello, Ph.D., was appointed to the company's board of directors in June 2025[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reported increased revenue and operating expenses for Q2 2025 and provided financial guidance through Q3 2026 [Q2 2025 Financial Highlights](index=3&type=section&id=Q2%202025%20Financial%20Highlights) Collaboration revenue grew to $8.1 million while net loss increased to $15.8 million, with a strengthened cash position of $121.6 million Q2 2025 Financial Performance (vs. Q2 2024) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration & License Revenue | $8.1M | $2.4M | +238% | | R&D Expenses | $15.3M | $11.2M | +37% | | G&A Expenses | $7.1M | $5.8M | +22% | | Net Loss | $15.8M | $13.9M | +14% | | Net Loss per Share | $(0.16) | $(0.24) | N/A | | Cash & Cash Equivalents (period end) | $121.6M | N/A | N/A | [Financial Guidance](index=3&type=section&id=Financial%20Guidance) The company's current cash position is expected to fund operations and capital expenditures through the end of Q3 2026 - The company expects its cash and cash equivalents as of June 30, 2025, to fund operating expenses and capital expenditure requirements **through the end of Q3 2026**[11](index=11&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) The report includes condensed consolidated balance sheets and statements of operations for the period ending June 30, 2025 [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to $133.8 million driven by a rise in cash, while total liabilities grew to $126.7 million Balance Sheet Summary (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $121,551 | $55,291 | | Total assets | $133,813 | $71,075 | | **Liabilities & Equity** | | | | Deferred revenue | $70,910 | $32,780 | | Common stock warrant liabilities | $38,550 | $0 | | Total liabilities | $126,744 | $53,477 | | Stockholders' equity | $7,069 | $17,598 | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $15.8 million for the three months ended June 30, 2025, on revenues of $8.1 million Statement of Operations Summary (in thousands) | Account | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Collaboration and license revenue | $8,084 | $2,357 | | Research and development | $15,330 | $11,216 | | General and administrative | $7,120 | $5,815 | | Total operating expenses | $22,450 | $17,061 | | Loss from operations | $(14,366) | $(14,704) | | Net loss | $(15,844) | $(13,925) | | Net loss per share | $(0.16) | $(0.24) |

EXHIBIT 99.1 MiNK Therapeutics Reports Clinical and Strategic Milestones and Second Quarter 2025 Results NEW YORK, Aug. 14, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, today announced financial results for the second quarter ended June 30, 2025, and provided a business update highlighting major clinical achievements, a strengthened balance sheet, and expanded ...

Advanced Flower Capital Inc. Announces Financial Results for the Second Quarter 2025 Second quarter 2025 GAAP net loss of $(13.2) million or $(0.60) per basic weighted average common share and Distributable Earnings of $3.4 million or $0.15 per basic weighted average common share (1) Announces Intention to Convert from Mortgage REIT to BDC WEST PALM BEACH, FL, August 14, 2025 – Advanced Flower Capital Inc. (Nasdaq: AFCG) ("Advanced Flower Capital", "AFC" or the "Company") today announced its results for the ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Exact Name of Registrant as Specified in its Charter) | Delaware | 85-4012572 | | --- | --- | | (State or other jurisdiction of | (I.R.S. Employer | | incorporation or organization) | Identification No.) | 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 EXCHAN ...

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 ...

Lexeo Therapeutics Reports Second Quarter 2025 Financial Results and Operational Highlights Breakthrough Therapy designation granted for LX2006 based on interim data from Phase I/II trials demonstrating clinically meaningful improvements in cardiac and neurologic measures of Friedreich ataxia Exhibit 99.1 LX2006 selected for FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program, created to facilitate CMC registrational readiness and support faster patient access Eight par ...

[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)