CLEVELAND, Oct. 30, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases, today announced that the Centers for Medicare and Medicaid Services (CMS) has established a permanent Healthcare Common Procedure Coding System (HCPCS) J-code for ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets, the Company’s autologous gene therapy for the treatment of wounds in adult and pediatric patien ...

Core Insights - Abeona Therapeutics Inc. has appointed Dr. James A. Gow as the Senior Vice President, Head of Clinical Development & Medical Affairs, effective immediately [1][2] - Dr. Gow brings over 20 years of experience in clinical development and medical affairs, with a focus on gene therapy, particularly in ophthalmology [2] - The company is advancing its pipeline of cell and gene therapies for serious diseases, including its lead product ZEVASKYN, which is the first autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa [3] Company Overview - Abeona Therapeutics is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases [3] - The company operates a fully integrated cGMP manufacturing facility in Cleveland, Ohio, which is responsible for the commercial production of ZEVASKYN [3] - Abeona's development portfolio includes adeno-associated virus (AAV)-based gene therapies targeting ophthalmic diseases with significant unmet medical needs [3]

Core Insights - Abeona Therapeutics' ABO-503 gene therapy for X-linked retinoschisis (XLRS) has been selected for the FDA's Rare Disease Endpoint Advancement (RDEA) Pilot Program, which aims to enhance communication and collaboration with the FDA to expedite the development of rare disease therapies [1][2][3] Company Overview - Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases, including the first autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa [5] - The company operates a fully integrated cGMP manufacturing facility in Cleveland, Ohio, which is responsible for the commercial production of its therapies [5] Industry Context - The RDEA Pilot Program, launched by the FDA, supports the development of novel efficacy endpoints for rare disease treatments, allowing for up to three proposals per year from sponsors [3] - XLRS is a rare, monogenic retinal disease with an estimated incidence of 1 in 5,000 to 1 in 20,000 in males, affecting approximately 35,000 individuals in the U.S. and Europe combined, with no approved disease-modifying therapies currently available [4]

Core Insights - Abeona Therapeutics has activated Children's Hospital Colorado as a Qualified Treatment Center for ZEVASKYN, a gene-modified therapy for recessive dystrophic epidermolysis bullosa (RDEB) [1][2] - ZEVASKYN is the first FDA-approved therapy for treating wounds in RDEB patients, offering a long-lasting treatment option and improved quality of life [2][5] - The collaboration aims to broaden access to ZEVASKYN across a network of established epidermolysis bullosa centers [2] Company Overview - Abeona Therapeutics is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases, with ZEVASKYN being its flagship product [11] - The company operates a cGMP manufacturing facility in Cleveland, Ohio, which is responsible for the commercial production of ZEVASKYN [11] Product Details - ZEVASKYN (prademagene zamikeracel) is an autologous cell sheet-based gene therapy designed to treat wounds in both adult and pediatric patients with RDEB [6][5] - The therapy incorporates the COL7A1 gene into a patient's skin cells to produce functional type VII collagen, which is essential for skin integrity [5][6] - Clinical results have shown meaningful wound healing and pain reduction with a single application of ZEVASKYN [5] Clinical and Research Context - Children's Hospital Colorado is recognized as a center of excellence for epidermolysis bullosa and is part of the EB Clinical Research Consortium, contributing to advanced research and treatment options [2][10] - The hospital's Precision Medicine Institute supports innovative treatments by utilizing patients' unique genetic information [2] Patient Support Services - Abeona offers a comprehensive patient support program called Abeona Assist, which helps patients navigate insurance benefits, financial assistance, and logistical support for treatment [3]

Summary of Abeona Therapeutics FY Conference Call Company Overview - **Company**: Abeona Therapeutics Inc. (NASDAQ: ABEO) - **Industry**: Biotechnology, specializing in cell and gene therapies for serious diseases Key Points and Arguments 1. **FDA Approval and Product Launch**: Abeona has received FDA approval for ZevaSkin™, a gene therapy for treating recessive dystrophic epidermolysis bullosa (RDEB) wounds in both adult and pediatric patients, marking a significant milestone as a commercial-stage company [4][5] 2. **Financial Position**: The company reports a strong cash position with $226 million as of June 30, 2025, providing over two years of operational runway without accounting for product revenue [28] 3. **Market Demand**: There is significant interest from the RDEB community, with nearly 50 patients identified for ZevaSkin™ treatment, and the company is in the process of activating additional qualified treatment centers (QTCs) [5][20] 4. **Treatment Efficacy**: In clinical trials, ZevaSkin™ demonstrated that 81% of treated wounds showed over 50% healing at six months, compared to 16% in control groups, along with a mean pain reduction of over threefold [13] 5. **Economic Burden of Disease**: The annual cost of bandaging for RDEB patients exceeds $245,000, with lifetime treatment costs reaching up to $15 million, highlighting the economic need for effective therapies like ZevaSkin™ [9][10] 6. **Pricing and Reimbursement**: ZevaSkin™ is priced at approximately $3.1 million per treatment, and there is positive momentum from insurance companies regarding reimbursement, with favorable policies from major payers like UnitedHealth and Cigna [5][24][25] 7. **Patient Support Programs**: Abeona has established the Abeona Assist™ program to provide travel support and logistics for patients needing treatment at QTCs, addressing potential barriers to access [19] 8. **Manufacturing Capacity**: The company is ramping up manufacturing capacity to meet growing demand, currently positioned to treat four patients per month, with plans for expansion [26][27] 9. **Long-term Profitability**: Abeona expects to achieve profitability by treating more than three patients per month, with projections indicating potential cumulative revenue exceeding $4 billion from ZevaSkin™ treatments [23][24] 10. **Pipeline Development**: Beyond ZevaSkin™, Abeona is developing additional AAV-based gene therapies for inherited retinal diseases, indicating a commitment to expanding its therapeutic offerings [28] Additional Important Content - **Patient Journey**: The treatment process involves a three to four-month timeline from initial consultation to treatment, including insurance clearance and biopsy [16][17] - **Community Engagement**: The company is actively engaging with the RDEB community through regional meetings and patient conferences to raise awareness and support for ZevaSkin™ [18] - **Clinical Trial Success**: The clinical trials focused on the toughest-to-treat wounds, demonstrating the product's effectiveness in real-world applications [14][15] This summary encapsulates the critical insights from the Abeona Therapeutics FY Conference Call, highlighting the company's strategic positioning, product efficacy, and market potential in the biotechnology sector.

Summary of Abeona Therapeutics (ABEO) 2025 Conference Call Company Overview - Abeona Therapeutics is a commercial-stage biotech company based in Cleveland, specializing in cell and gene therapy, particularly for patients with recessive dystrophic epidermolysis bullosa (RDEB) [4][5] - The company has launched its lead product, ZivaSkin, which is an autologous cell-based gene therapy aimed at treating large, chronic wounds associated with COL7 deficiency [4][5] Key Highlights - **Product Launch and Demand**: - ZivaSkin has shown strong initial demand with approximately 50 patients identified for treatment, even before a dedicated sales force was established [5][6] - The company has two qualified treatment centers (QTCs) operational, with plans to expand further [22][24] - **Patient Profile**: - The initial patient cohort includes severe cases with large, chronic wounds, many of whom are treatment naive or have previously tried other therapies [7][9][36] - An estimated 750 patients with severe and moderate wounds are eligible for ZivaSkin across 23 centers of excellence [9][10] - **Clinical Evidence**: - ZivaSkin's clinical trials have demonstrated unique efficacy in treating chronic wounds that have remained open for extended periods, with some patients experiencing wounds that have not healed for up to 21 years [12][13] - The therapy aims to provide durable wound healing and pain reduction after a single application [4][12] - **Manufacturing and Capacity**: - Initial manufacturing capacity is set at two patients per QTC per month, with plans to ramp up to 10 patients per month by mid-2026 [22][50] - The company is preparing for potential scalability in manufacturing to meet increasing demand [50][51] Market Potential and Financial Outlook - **Patient Demand and Market Potential**: - The company anticipates treating 10 to 14 patients in 2025, with a strong pipeline of referrals already in place [26][29] - The process from patient identification to treatment is expected to take about four months initially, with improvements anticipated as the process becomes more streamlined [30][32] - **Reimbursement Landscape**: - Positive trends in payer coverage have been observed, with all prior authorizations submitted so far being approved, some within 48 hours [41][42] - Approximately 60% of patients are commercially insured, with favorable coverage policies emerging from major payers like United Health [43][45] Additional Insights - **Patient Experience and Logistics**: - The treatment process involves multiple administrative steps, including insurance clearance and biopsy collection, which are expected to improve over time [17][18] - Patients are willing to travel significant distances to access treatment, indicating a strong commitment to receiving ZivaSkin [24][25] - **Future Developments**: - Abeona is also developing proprietary capsids for retinal inherited diseases, with clinical trials expected to start in late 2026 [55] - The company emphasizes the importance of execution in the current phase, with a strong balance sheet supporting its operations [54] Conclusion - Abeona Therapeutics is positioned for growth with its innovative ZivaSkin therapy, strong initial demand, and positive reimbursement trends. The company is focused on expanding its treatment capacity and enhancing patient access while preparing for future product developments in its pipeline.

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Financial Data and Key Metrics Changes - As of June 30, 2025, the company reported unaudited cash, cash equivalents, short-term investments, and restricted cash of $225.9 million, a significant increase from $98.1 million as of December 31, 2024, providing over two years of operating capital without further capital infusion [15][16] - Net income for the second quarter of 2025 was $108.8 million, or $2.07 per basic share, compared to a net income of $7.4 million, or $0.19 per basic share, in the same quarter of 2024 [18] Business Line Data and Key Metrics Changes - The company has seen strong interest in ZevaSkin, with over 50 identified patients across two qualified treatment centers (QTCs) and expectations to treat 10 to 14 patients in 2025 [14][5] - Research and development expenses decreased to $5.9 million for the quarter ended June 30, 2025, from $9.2 million in the same quarter of 2024, primarily due to costs capitalized into inventory [17] Market Data and Key Metrics Changes - The company has achieved positive coverage with multiple national and regional payers, with 100% of prior authorization requests approved to date, indicating strong clinical acceptance among payers [11][12] - Approximately 60% of RDEB lives are covered by commercial plans, 30% by Medicaid, and the rest by Medicare, highlighting the market potential for ZevaSkin [10] Company Strategy and Development Direction - The company is focused on expanding its geographic footprint by activating additional QTCs to ease travel burdens for patients and increase demand for ZevaSkin [8][14] - The company plans to transition into a revenue-generating commercial entity and will provide high-level forward cost guidance alongside updates on commercialization progress [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the initial launch progress of ZevaSkin, citing positive feedback from the RDEB community and the potential to improve patient lives [4][14] - The company anticipates that the first ZevaSkin patient treatment will occur in 2025, leading to projected company-wide profitability in early 2026 [16] Other Important Information - The company has partnered with Deborah of America for a nationally broadcast webinar to share patient experiences, which has positively influenced community engagement [13] - The company is exploring opportunities for EU and Japan market entries, considering the feasibility of supplying from its Cleveland facility [77] Q&A Session Summary Question: How are identified patients defined? - Identified patients are those with severe wounds that have never healed, prioritized by physicians for treatment with ZevaSkin [24][25] Question: What is the treatment timeline for patients outside the two QTCs? - Patients have started the referral process and are going through initial consultations, with plans to activate additional treatment centers to facilitate their treatment [26][27] Question: How many cases does a center need to treat before adopting ZevaSkin as routine therapy? - There is no specific number of pre-treatments required; centers are confident in treating patients based on their experience with RDEB patients [33][36] Question: What are the payment mechanics for ZevaSkin? - Revenue is recognized after a patient has been treated with ZevaSkin, with hospitals able to secure payer agreements before placing orders [49][51] Question: What is the status of prior authorizations? - The company has seen a 100% approval rate for prior authorizations, with no pushback from payers regarding prior treatments before approving ZevaSkin [58][55] Question: What are the production capacity plans? - The company is on track to ramp up production capacity to treat 10 patients per month by mid-2026, with no anticipated FDA inspections affecting this timeline [64][68] Question: What are the expectations for the EU market? - The company is exploring the EU market but acknowledges that establishing a manufacturing footprint there would take significant time [77]

[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)

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].