Disc is seeking accelerated approval and priority review of its NDA submissionFDA decision to accept and file the NDA for review occurs within 60 days of submission WATERTOWN, Mass., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced the submission of a New Drug Application (NDA) to the U.S. Fo ...

PresentationSean LaamanHead of Healthcare Research & Equity Analyst Good afternoon, everyone, and welcome to Morgan Stanley Global Healthcare Conference. I'm Sean Laaman, U.S. Head of SMid-Cap Biotech Equity Research here at the firm. Before we commence, for important disclosures, please see Morgan Stanley research disclosure website at www.morganstanley.com/research disclosures. And if you have any questions, please reach out to your Morgan Stanley sales representative. For this session, we have Disc Medic ...

Summary of Disc Medicine FY Conference Call Company Overview - **Company**: Disc Medicine (NasdaqGM: IRON) - **Focus**: Red blood cell biology through manipulation of heme and iron metabolism - **Pipeline**: Three molecules in clinical stages, with lead program Bitopertin for erythropoietic protoporphyria (EPP) [2][6] Key Points Product Development and Pipeline - **Bitopertin**: NDA submission expected in October 2025, with potential launch in 2026 [2][6] - **Other Programs**: Two additional programs targeting myeloproliferative disorders, currently in phase two with data expected by year-end [2][6] - **Patient Population**: Estimated 14,000 patients in the U.S. with EPP, with 6,000 actively seeking therapy [9][10] Competitive Landscape - **Collaboration**: One program in-licensed from a Chinese biotech, indicating a positive collaboration experience [3] - **Market Position**: No significant competition identified in the U.S. or China for the unique biology being targeted [3] Regulatory Environment - **FDA Interactions**: Positive feedback from the FDA regarding rare disease development, aiding in the approval process [5] Commercial Strategy - **Launch Preparations**: Chief Commercial Officer hired, focusing on understanding the patient population and engaging with physicians [6][7] - **Sales Strategy**: Targeting 6,000 engaged patients initially, with plans to expand outreach through advocacy groups and social media [10][11] Clinical Data and Efficacy - **Dosing Strategy**: 60 mg dose of Bitopertin shows a 50% reduction in toxic metabolite PP-9, correlating with clinical improvement [14] - **Quality of Life**: Sustained PP-9 reductions lead to improved patient-reported outcomes [16] Upcoming Trials - **Apollo Trial**: Confirmatory trial for Bitopertin with 150 patients expected to enroll by May 2026 [19] - **RALI-MF Trial**: Focused on anemia in myelofibrosis, with data readout anticipated in Q4 2025 [34] Financial Position - **Cash Reserves**: $650 million as of Q2 2025, projected to fund operations into 2028, including commercial launch expenses for Bitopertin [61] Future Opportunities - **Potential Indications**: Exploring applications for iron overload conditions and sickle cell disease [59] Additional Insights - **AI Utilization**: Exploring AI for streamlining clinical and regulatory documentation [4] - **Patient Impact**: EPP significantly affects quality of life, with severe light sensitivity leading to lifestyle limitations [26][27] This summary encapsulates the critical aspects of Disc Medicine's conference call, highlighting the company's strategic direction, product pipeline, and market positioning.

Summary of Disc Medicine FY Conference Call Company Overview - **Company**: Disc Medicine (NasdaqGM:IRON) - **Market Cap**: Approximately $2 billion as of the call date [2] - **Focus**: Red blood cell biology, specifically treating diseases related to iron and heme metabolism [2] Lead Programs - **Bidipertin**: - Licensed from Roche, currently in the accelerated approval pathway with an NDA filing projected for October [3] - Confirmatory trial named APOLLO is underway [4] - **Pipeline**: - Two phase two programs targeting myeloproliferative diseases [4] - **DISCO-nine 74**: Focused on myelofibrosis anemia and anemia of chronic kidney disease, with readouts expected at ASN or ASH [4] - **DISC 3,405**: Aiming to manage hematocrit in polycythemia vera [4] Clinical Data and Regulatory Insights - **Bidipertin**: - Data from HELIOS study indicates a reduction in protoporphyrin nine (PP9) levels, which correlates with improved liver health outcomes [7] - KOLs (Key Opinion Leaders) are supportive of the drug's potential liver protection [8] - No expectation for liver protection to be included in the label claim without further studies [9][10] - **Pediatric Plans**: - Inclusion of adolescents in the approval process is planned, with ongoing enrollment in the APOLLO trial [14] - Future studies for younger patients are anticipated post-approval [17] Commercial Strategy - **Commercial Team**: - Building a team with experience in rare disease launches, including a Chief Commercial Officer and a medical affairs team [24] - **Patient Engagement**: - Identified 14,000 diagnosed patients in the US, with a focus on engaging the 6,000 who are actively seeking care [27] - Plans to utilize patient advocacy and social media to reach patients who have disengaged from treatment [28] Competitive Landscape - **DISCO-nine 74**: - Positioned as a unique treatment for anemia in myelofibrosis, especially as other therapies like momalotinib are not effectively addressing anemia [30][31] - Preliminary data suggests that DISCO-nine 74 may work effectively alongside momalotinib [35] Future Development Plans - **CKD Anemia**: - Ongoing studies to assess the efficacy of DISCO-nine 74 in chronic kidney disease anemia, with plans for a phase two trial depending on data outcomes [46][48] - **DISC 3,405**: - Currently in phase two, with data projections for the next year, aiming to provide a better dosing regimen for polycythemia vera patients [52] Key Takeaways - Disc Medicine is advancing its lead program bidipertin towards accelerated approval, with a strong pipeline in red blood cell-related diseases. - The company is actively engaging with KOLs and patients to build a robust commercial strategy. - Competitive positioning is strengthened by the unique therapeutic profile of DISCO-nine 74 in managing anemia in myelofibrosis and potential applications in CKD. - Future studies and data will be critical in determining the success of their ongoing and planned clinical trials.

Financial Data and Key Metrics Changes - The company is preparing to file its New Drug Application (NDA) for bitopertin in October, with a potential PDUFA date between June and October of the following year, marking a significant milestone for the company [4][5] - The company reported a P-value of less than 0.001 for the reduction in protoporphyrin-9 (PP9), indicating a clinically meaningful reduction in patients with erythropoietic protoporphyria [9][10] Business Line Data and Key Metrics Changes - The lead program, bitopertin, is in the accelerated approval pathway with the FDA, focusing on rare diseases related to red blood cell biology [4][5] - The second program is expected to present data on anemia of myelofibrosis and anemia of chronic kidney disease at upcoming conferences [5][6] Market Data and Key Metrics Changes - The company identified approximately 14,000 diagnosed patients in the U.S. for the target disease, with enrollment in trials not being a problem due to strong patient advocacy [18][23] - The company plans to leverage claims data to identify and validate physicians treating these patients, enhancing their market access strategy [23][24] Company Strategy and Development Direction - The company is focused on increasing disease awareness and ensuring that patients and physicians are informed about available therapies, as historically there have been no options for these patients [22][23] - The company aims to build a self-sustaining entity driven by revenues from bitopertin, with plans to explore additional indications within their iron modulation programs [60][61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory pathway for bitopertin, citing positive interactions with the FDA regarding the use of PP9 as a surrogate endpoint [10][11] - The management highlighted the importance of continuous engagement with healthcare providers to ensure that patients receive appropriate care and treatment options [26][30] Other Important Information - The company has a strong financial position with $650 million on the balance sheet, which is expected to fund operations into 2028 [60] - The company has orphan protection for bitopertin, providing seven years of exclusivity in the U.S. plus potential pediatric extensions [36] Q&A Session Summary Question: Can you recap the interactions with the FDA regarding the accelerated approval path for bitopertin? - Management detailed a series of meetings with the FDA that led to the decision to pursue an accelerated approval pathway, emphasizing the strong rationale for using PP9 as a surrogate endpoint [10][11] Question: What are the key differences between the Apollo and Aurora trials? - Management explained that the Apollo trial will focus on measuring the time patients can spend in light, which is a clinically meaningful endpoint, alongside the reduction in PP9 levels [18][19] Question: How does the company plan to address the patient population for bitopertin? - Management discussed the importance of identifying engaged patients who regularly seek healthcare, estimating about 6,000 such patients, while also planning to reach out to the remaining diagnosed but less engaged patients [26][27] Question: What is the expected market opportunity for the company's anemia treatments? - Management indicated that there is a significant unmet need for anemia treatments in myelofibrosis, with an estimated market of about 22,000 patients, and potential pricing similar to existing therapies [42][44] Question: How does the company view its capital position and future financing needs? - Management expressed confidence in their capital position, indicating that they are well-funded to support ongoing trials and commercial preparations without immediate need for additional equity financing [60][61]

Financial Data and Key Metrics Changes - The company is preparing to file its New Drug Application (NDA) for bitopertin in October, with a potential PDUFA date between June and October of the following year, marking a significant milestone for the company [4][5] - The company reported a strong reduction in protoporphyrin-9 (PP9) levels with a P-value of less than 0.001, indicating clinically meaningful results from its phase 2 studies [9][10] Business Line Data and Key Metrics Changes - The lead program, bitopertin, is focused on treating erythropoietic protoporphyria, with the company ramping up efforts for its launch [4][5] - The second program is expected to present data on anemia of myelofibrosis and anemia of chronic kidney disease at upcoming conferences [5][6] Market Data and Key Metrics Changes - The company identified approximately 14,000 diagnosed patients in the U.S. for its lead indication, with enrollment in trials not being a problem due to strong patient advocacy [19][24] - The company plans to target the European and Japanese markets, with the genetic prevalence in Japan estimated to be four times higher than in the U.S. [39] Company Strategy and Development Direction - The company is focused on raising disease awareness and ensuring that patients and physicians are informed about available therapies, which is crucial given the historical lack of treatment options [23][24] - The company aims to build a self-sustaining entity driven by revenues from bitopertin to support its broader heme portfolio and explore larger indications [62] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory pathway for bitopertin, highlighting positive interactions with the FDA regarding the accelerated approval process [11][12] - The company is well-funded with $650 million on the balance sheet, providing a runway into 2028 to support ongoing trials and commercial preparations [62] Other Important Information - The company has orphan protection for bitopertin, which provides seven years of exclusivity in the U.S., along with method-of-use patents extending until 2042 [37] - The safety profile of bitopertin shows that dizziness occurs in over 50% of patients initially but resolves over time, indicating a manageable side effect [35] Q&A Session Summary Question: Can you recap the interactions with the FDA regarding the accelerated approval path for bitopertin? - The company had a series of meetings with the FDA, which were responsive to the rationale for using PP9 as a surrogate endpoint, leading to the decision to submit an NDA this fall [11][12] Question: What are the key differences between the Apollo and Aurora trials? - Apollo will focus on measuring the time patients can spend in light as a co-primary endpoint, while Aurora primarily assessed the reduction in PP9 levels [18][20] Question: How does the company plan to address the patient population for bitopertin? - The company segments the patient population based on engagement with healthcare providers, identifying about 6,000 engaged patients who regularly seek care [27][28] Question: What is the expected market opportunity for the anemia treatment in myelofibrosis? - The company estimates a market of about 22,000 patients for anemia in myelofibrosis, with potential pricing similar to other anemia treatments in related indications [45] Question: How does the company view its capital position and runway? - The company is well-funded and expects its current capital to support its operations and trials through 2028, aiming to become self-sustaining through revenues from bitopertin [62]

Financial Data and Key Metrics Changes - The company is preparing to file its New Drug Application (NDA) for bitopertin in October, with a potential PDUFA date between June and October of the following year, marking a significant milestone for the company [4][5][11] - The company reported a strong reduction in protoporphyrin-9 (PP9) levels with a P-value of less than 0.001, indicating clinically meaningful results from its phase 2 studies [9][10] Business Line Data and Key Metrics Changes - The lead program, bitopertin, is focused on treating erythropoietic protoporphyria, with plans for an accelerated approval pathway [4][5] - The second program is expected to present data on anemia of myelofibrosis and anemia of chronic kidney disease at upcoming conferences [5][6] Market Data and Key Metrics Changes - The company identified approximately 14,000 diagnosed patients in the U.S. for its lead indication, with expectations for rapid enrollment in clinical trials [19] - The market for bitopertin is expected to be significant, with pricing comparisons to existing therapies like Scenesse, which is priced at $300,000 to $350,000 per year [36] Company Strategy and Development Direction - The company is focused on increasing disease awareness and ensuring that healthcare providers are informed about available therapies for rare diseases [23][24] - The company plans to leverage claims data to identify and engage with physicians who treat diagnosed patients, enhancing its commercial strategy [24][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory pathway for bitopertin, citing positive interactions with the FDA regarding the use of PP9 as a surrogate endpoint [11][12] - The company is well-funded with $650 million on its balance sheet, providing a runway into 2028 to support ongoing trials and commercial preparations [62] Other Important Information - The company has orphan drug designation for bitopertin, providing seven years of market exclusivity in the U.S. [37] - The company is also exploring additional indications for its iron modulation programs, indicating a broad pipeline strategy [62] Q&A Session Summary Question: Can you recap the interactions with the FDA regarding the accelerated approval path for bitopertin? - Management detailed a series of meetings with the FDA that confirmed the rationale for an accelerated approval pathway based on phase 2 data and the use of PP9 as a surrogate endpoint [11][12] Question: What are the key differences between the Apollo and Aurora trials? - The Apollo trial will focus on measuring the time patients can spend in light as a co-primary endpoint, alongside the reduction of PP9 levels [19][20] Question: How does the company plan to address the patient population for bitopertin? - The company plans to segment the patient population based on engagement with healthcare providers, identifying approximately 6,000 engaged patients and 8,000 less engaged patients [27][28] Question: What is the expected pricing strategy for bitopertin? - The company anticipates pricing in line with existing therapies for rare diseases, potentially around $300,000 to $350,000 per year [36] Question: How does the company view the competitive landscape for its anemia treatments? - Management highlighted the significant unmet need in treating anemia in myelofibrosis, positioning their drug as the only one currently in development for this indication [43][44]

Summary of Disc Medicine Conference Call Company Overview - **Company**: Disc Medicine - **Focus**: Development of treatments for diseases related to red blood cell metabolism, specifically through manipulation of iron and heme metabolism [5][6] Key Programs 1. **Bidipertin** - **NDA Filing**: Scheduled for October 2025 with expected acceptance in December 2025, leading to a PDUFA date in 2026 [5] - **Patient Data**: Approximately 6,000 engaged patients identified from a claims database, with a total of 14,000 diagnosed patients [8][9] - **Market Strategy**: MSLs (Medical Science Liaisons) are engaging with physicians to confirm patient existence and raise disease awareness [10][13] - **Patient Education**: Emphasis on educating patients about the new therapy post-approval, with a focus on transitioning from clinical trials to commercial therapy [19][20] 2. **DISCO-974** - **Indication**: Targeting anemia of myelofibrosis (MF) with data cuts expected to be presented at ASH [6] - **Competitive Landscape**: Comparison with luspatercept, which failed in Phase 3 trials, highlighting the potential for DISCO-974 to address anemia more effectively across various patient subgroups [46][48] 3. **Chronic Kidney Disease (CKD) Anemia** - **Phase 1b SADMAD Program**: Data expected to be presented at ASN or ASH, focusing on iron mobilization and hemoglobin response [61][62] - **Future Trials**: Plans for a Phase 2 trial to confirm efficacy based on initial data, with a focus on identifying responding populations [63][64] Regulatory and Market Considerations - **Regulatory Alignment**: Confidence in the design of the Apollo confirmatory trial based on successful Phase 2 data, with a focus on minimizing placebo effects [38][41] - **Market Entry Strategy**: Anticipation of a gradual launch process, with emphasis on payer approval and physician engagement [22][24] - **Patient Population**: Targeting a significant unmet need in rare diseases, with a focus on educating both patients and physicians about new treatment options [19][57] Competitive Landscape - **Comparative Analysis**: Insights drawn from other rare disease launches, particularly Solano in rare obesity, and the challenges faced by luspatercept in treating anemia [33][46] - **Market Size**: Potential to address a population of approximately 22,000 anemic patients in the U.S. [56] Additional Insights - **Patient Advocacy**: Strong support from patient advocacy groups, which aids in raising awareness and sharing patient success stories [37] - **Data Presentation**: Upcoming data presentations at ASH are expected to provide further clarity on the efficacy and competitive positioning of DISCO-974 and other programs [56][65] This summary encapsulates the key points discussed during the conference call, highlighting the strategic direction and anticipated developments for Disc Medicine.

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 (State or other jurisdiction of incorporation or organization) 321 Arsenal Street, Suite 101 Watertown, Massachusetts 02472 (Address of principal executive offices) (Zip Code) Delaware 85-1612845 (I.R. ...

[Introduction](index=1&type=section&id=Introduction) This section provides an overview of Disc Medicine, its recent financial performance, and strategic pipeline advancements [Company Overview and CEO Statement](index=1&type=section&id=Company%20Overview%20and%20CEO%20Statement) Disc Medicine reported Q2 2025 results, advancing bitopertin NDA and other pipeline programs, with cash runway into 2028 - Disc Medicine is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel treatments for patients suffering from serious hematologic diseases [2](index=2&type=chunk)[11](index=11&type=chunk) - On track to submit an NDA for bitopertin in EPP under the accelerated approval pathway in **October 2025**, following positive feedback from a pre-NDA meeting [3](index=3&type=chunk)[6](index=6&type=chunk) - Initiated a Phase 2 study of DISC-3405 in polycythemia vera and expects data from the Phase 2 trial of DISC-0974 in MF anemia and Phase 1b trial in NDD-CKD anemia in the **second half of the year** [3](index=3&type=chunk)[6](index=6&type=chunk) - Maintains a **strong balance sheet** that provides cash runway into **2028**, positioning the company for potential commercialization of bitopertin and pipeline advancement [3](index=3&type=chunk)[6](index=6&type=chunk) [Recent Highlights and Anticipated Milestones](index=1&type=section&id=Recent%20Highlights%20and%20Anticipated%20Milestones) This section details Disc Medicine's progress across its key clinical programs and corporate developments, outlining significant achievements and upcoming milestones [Bitopertin Program Update](index=1&type=section&id=Bitopertin%20Program%20Update) Bitopertin is on track for EPP NDA submission in October 2025, supported by positive pre-NDA feedback and favorable HELIOS data - Company on track to submit NDA for bitopertin in erythropoietic protoporphyria (EPP) under accelerated approval pathway in **October 2025**, supported by successful pre-NDA meeting [6](index=6&type=chunk)[7](index=7&type=chunk) - Presented data from HELIOS, an ongoing open-label extension study, showing **favorable long-term efficacy and safety** with sustained protoporphyrin IX (PPIX) reductions, improvement in quality of life, and improved liver biomarkers [6](index=6&type=chunk)[7](index=7&type=chunk) - Progressing confirmatory Phase 3 APOLLO clinical trial of bitopertin in adults and adolescents with EPP [7](index=7&type=chunk) - Publication of preclinical study results showing bitopertin may help **prevent liver disease in EPP**, in addition to ameliorating blood PPIX levels [7](index=7&type=chunk) [DISC-0974 Program Update](index=1&type=section&id=DISC-0974%20Program%20Update) DISC-0974 is progressing with initial data expected in Q4 2025 from Phase 2 MF anemia and Phase 1b NDD-CKD - Expect initial data from Phase 2 study of DISC-0974 in patients with anemia of myelofibrosis (MF) and multiple dose data from Phase 1b study in NDD-CKD in **Q4 2025** [6](index=6&type=chunk)[13](index=13&type=chunk) - Presented clinical data from the continuation phase of the Phase 1b trial of DISC-0974 in MF anemia demonstrating **durable hematologic response** at EHA 2025 [6](index=6&type=chunk)[13](index=13&type=chunk) - RALLY-MF Phase 2 study's exploratory cohort for patients on concomitant momelotinib or pacritinib is fully enrolled, and the trial protocol was updated to allow these patients into main study cohorts [13](index=13&type=chunk) [DISC-3405 Program Update](index=2&type=section&id=DISC-3405%20Program%20Update) DISC-3405 initiated a Phase 2 study in PV with initial data expected in 2026, backed by Phase 1 proof-of-mechanism data - Initiated a Phase 2 study of DISC-3405 in patients with PV with initial data expected in **2026** [6](index=6&type=chunk)[13](index=13&type=chunk) - Presented updated SAD/MAD data from the Phase 1 trial of DISC-3405 in healthy volunteers providing **proof of mechanism** to support advancement of the program at EHA 2025 [6](index=6&type=chunk)[13](index=13&type=chunk) [Corporate Developments](index=2&type=section&id=Corporate%20Developments) Nadim Ahmed joined Disc Medicine's Board in July 2025, bringing extensive hematology development and commercial leadership - Appointed Nadim Ahmed, President and CEO of Cullinan Therapeutics, to the Company's Board of Directors in **July**, bringing over **25 years of development and commercial leadership experience** including multiple product launches in the hematology space [9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) This section presents Disc Medicine's financial performance for the second quarter of 2025, detailing key income statement and balance sheet figures [Financial Summary](index=2&type=section&id=Financial%20Summary) Disc Medicine reported a **$55.2 million net loss** in Q2 2025, driven by higher operating costs, maintaining **$650.0 million cash** into 2028 Financial Metric (Q2 2025) | Financial Metric (Q2 2025) | 2025 (in millions) | 2024 (in millions) | YoY Change | | :------------------------- | :----------------- | :----------------- | :--------- | | Research and Development | $46.3 | $23.5 | +97.0% | | Selling, General & Admin | $15.1 | $7.4 | +104.1% | | Net Loss | $(55.2) | $(26.4) | +109.1% | - Cash, cash equivalents, and marketable securities were **$650.0 million** as of June 30, 2025, which are expected to fund operational plans into **2028** [6](index=6&type=chunk)[13](index=13&type=chunk) - The increase in R&D expenses was primarily driven by the progression of Disc's portfolio, including bitopertin's clinical studies and drug manufacturing, the advancement of the DISC-0974 program, increased headcount, and a **$10 million milestone payment** upon initiation of the APOLLO study [13](index=13&type=chunk) - The increase in SG&A expenses was primarily due to increased headcount including establishing infrastructure to support potential commercialization [13](index=13&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a **net loss of $55.2 million** for Q2 2025, up from **$26.4 million** in Q2 2024, due to higher R&D and SG&A Statements of Operations (in thousands) | Metric (in thousands) | 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 | $46,319 | $23,485 | $74,082 | $47,189 | | Selling, general and administrative | $15,091 | $7,367 | $27,274 | $15,125 | | Total operating expenses | $61,410 | $30,852 | $101,356 | $62,314 | | Loss from operations | $(61,410) | $(30,852) | $(101,356) | $(62,314) | | Other income (expense), net | $6,215 | $4,560 | $12,195 | $9,078 | | Income tax expense | $(52) | $(60) | $(171) | $(65) | | Net loss | $(55,247) | $(26,352) | $(89,332) | $(53,301) | | Net loss per share, basic and diluted | $(1.58) | $(1.03) | $(2.61) | $(2.11) | | Weighted-average common shares outstanding, basic and diluted | 35,024,592 | 25,649,043 | 34,179,364 | 25,229,456 | [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to **$665.1 million** as of June 30, 2025, driven by **$650.0 million cash**, with equity rising to **$614.2 million** Balance Sheets (in thousands) | Metric (in thousands) | June 30, 2025 (Unaudited) | December 31, 2024 | | :-------------------- | :------------------------ | :---------------- | | Cash, cash equivalents, and marketable securities | $649,973 | $489,881 | | Total current assets | $661,592 | $493,615 | | Total assets | $665,061 | $496,773 | | Total liabilities | $50,896 | $53,186 | | Total stockholders' equity