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Viridian Therapeutics(VRDN) - 2025 Q3 - Quarterly Results
2025-11-05 12:09
Financial Position - Viridian Therapeutics reported a cash position of approximately $887.9 million as of October 31, 2025, following a comprehensive financing package[5] - Cash, cash equivalents, and short-term investments decreased to $490.90 million as of September 30, 2025, down from $717.58 million at the end of 2024[26] - Total assets decreased to $577.14 million as of September 30, 2025, compared to $742.40 million at the end of 2024[26] - Total stockholders' equity fell to $502.97 million as of September 30, 2025, down from $671.64 million at the end of 2024[26] Revenue and Expenses - Total revenue for Q3 2025 was $70.57 million, a significant increase from $86,000 in Q3 2024[24] - License revenue for Q3 2025 was $70 million, while collaboration revenue from related parties was $570,000[24] - Total operating expenses for Q3 2025 were $110.58 million, compared to $83.57 million in Q3 2024, reflecting a 32.3% increase[24] - The net loss for Q3 2025 was $34.60 million, an improvement from a net loss of $76.69 million in Q3 2024[24] - Research and development expenses increased to $86.3 million for the three months ended September 30, 2025, compared to $69.2 million for the same period in 2024, driven by ongoing clinical trials[11] - General and administrative expenses rose to $24.3 million for the three months ended September 30, 2025, up from $14.4 million in the prior year, primarily due to preparatory activities for veligrotug[11] - Research and development expenses for the nine months ended September 30, 2025, were $249.72 million, up from $166.29 million for the same period in 2024[24] - General and administrative expenses for the nine months ended September 30, 2025, were $61.64 million, compared to $45.50 million for the same period in 2024[24] Clinical Trials and Product Development - Enrollment in pivotal clinical trials REVEAL-1 and REVEAL-2 for VRDN-003 exceeded targets, with 132 and 204 patients enrolled, respectively[11] - The Biologics License Application (BLA) for veligrotug was submitted to the FDA in October 2025, with a request for Priority Review and a potential U.S. commercial launch anticipated in mid-2026[5] - VRDN-006 demonstrated proof-of-concept IgG reduction in a phase 1 clinical trial, while VRDN-008 is on track for an Investigational New Drug (IND) filing by year-end 2025[11] - The company anticipates topline data readouts for VRDN-003 from REVEAL-1 in Q1 2026 and REVEAL-2 in Q2 2026, with a BLA submission planned for year-end 2026[11] Financing Activities - The company completed a public equity offering in October 2025, raising total gross proceeds of $289.1 million by selling 13,138,750 shares at $22.00 per share[4] - The company secured a royalty financing agreement with DRI Healthcare for up to $300 million, including $55 million upfront and $115 million in near-term milestones[8] Market Focus - Viridian is focused on a core group of approximately 2,000 prescribers in the $2 billion annual TED market, with strong enthusiasm for veligrotug among key opinion leaders[6]
Lineage, Inc.(LINE) - 2025 Q3 - Quarterly Report
2025-11-05 12:09
Financial Performance - Net revenues for Q3 2025 were $1,377 million, a 3.1% increase from $1,335 million in Q3 2024[18] - The company reported a net loss of $112 million for Q3 2025, compared to a net loss of $543 million in Q3 2024[18] - Basic earnings per share for Q3 2025 were $(0.44), an improvement from $(2.44) in Q3 2024[18] - Comprehensive income for Q3 2025 was $(152) million, compared to $(474) million in Q3 2024, indicating a reduction in losses[18] - Net income for the nine months ended September 30, 2025, was $(119) million, compared to $(671) million for the same period in 2024, showing a significant improvement[27] Operational Costs - Cost of operations increased to $932 million in Q3 2025, compared to $897 million in Q3 2024, reflecting a 3.9% rise[18] - The company incurred acquisition, transaction, and other expenses of $12 million in Q3 2025, significantly lower than $592 million in Q3 2024[18] - Stock-based compensation expenses totaled $38 million, a slight increase from $34 million in the prior period, indicating ongoing investment in employee incentives[24] - Stock-based compensation expenses decreased to $107 million in 2025 from $171 million in 2024, a decline of 37.4%[27] Assets and Liabilities - Total assets as of September 30, 2025, were $19,197 million, up from $18,661 million as of December 31, 2024[16] - Total liabilities increased to $9,812 million as of September 30, 2025, compared to $8,967 million at the end of 2024, marking a 9.5% rise[16] - The company’s retained earnings showed a deficit of $2,325 million as of September 30, 2025, compared to a deficit of $1,855 million at the end of 2024[16] - The company’s total stockholders' equity decreased to $8,383 million as of September 30, 2025, from $8,638 million at the end of 2024[16] Cash Flow and Investments - Net cash provided by operating activities increased to $627 million in 2025 from $446 million in 2024, reflecting a 40.5% increase[27] - Cash flows used in investing activities rose to $(899) million in 2025, compared to $(536) million in 2024, indicating a 67.7% increase in investment outflows[27] - The company made acquisitions net of cash acquired totaling $(441) million in 2025, compared to $(113) million in 2024, reflecting a 290.3% increase in acquisition spending[27] Equity and Shareholder Returns - The company declared dividends of $0.53 per common share, consistent with previous distributions, indicating a stable return to shareholders[24] - The company distributed $100 million in dividends and other distributions during the quarter ending June 30, 2024[20] - The total number of shares outstanding remained stable, with no significant changes reported during the period[24] Debt and Financing - Total debt increased to $5,968 million as of September 30, 2025, up from $4,976 million at December 31, 2024, representing a 22% increase[130] - The Company issued $500 million in 5.25% senior notes on June 17, 2025, due July 15, 2030, with interest payable starting January 15, 2026[143] - The Company maintained compliance with all financial covenants as of September 30, 2025, including a maximum total indebtedness to total assets ratio of less than 0.60 to 1.00[145] Acquisitions and Divestitures - The company completed acquisitions totaling $119 million for Bellingham Cold Storage and $60 million for other assets during the nine months ended September 30, 2025[106] - The company recorded a loss of $60 million on the divestiture of Lineage Spain Transportation, which closed on August 29, 2025[113] - Goodwill increased to $3.473 billion as of September 30, 2025, reflecting acquisitions and measurement period adjustments[115] Legal and Regulatory Matters - The Company is currently involved in a putative class action lawsuit related to its IPO, which is at a preliminary stage, with potential implications for financial reporting[212] Market Conditions and Future Outlook - Future outlook includes potential market expansion and product development initiatives to enhance revenue streams[24] - The company is focusing on maintaining a consistent dividend policy while managing its equity and debt levels[24]
DigitalOcean(DOCN) - 2025 Q3 - Quarterly Results
2025-11-05 12:07
Exhibit 99.1 DigitalOcean Announces Third Quarter 2025 Financial Results BROOMFIELD, Colo., November 5, 2025 – DigitalOcean Holdings, Inc. (NYSE: DOCN), the comprehensive agentic cloud, today announced results for its third quarter ended September 30, 2025. "DigitalOcean's unified agentic cloud is driving accelerated momentum in Q3. Revenue increased 16% year over year and we delivered the strongest incremental organic ARR in our history," said Paddy Srinivasan, CEO of DigitalOcean. "Our unified agentic clo ...
Geron(GERN) - 2025 Q3 - Quarterly Results
2025-11-05 12:06
Exhibit 99.1 Geron Corporation Reports Third Quarter 2025 Financial Results and Recent Business Highlights Achieved $47.2 million in RYTELO® net product revenue in Q3 2025 Completed enrollment in Phase 3 IMpactMF clinical trial evaluating imetelstat in relapsed/refractory myelofibrosis Strengthened leadership team with appointment of Chief Commercial Officer and additional key executives Announced one oral and four poster presentations accepted at the American Society of Hematology (ASH) 2025 Annual Meeting ...
Sachem Capital(SACH) - 2025 Q3 - Quarterly Report
2025-11-05 12:05
Loans and Investments - Loans disbursed for the three months ended September 30, 2025, totaled $44.657 million, while loans repaid amounted to $40.651 million[129]. - As of September 30, 2025, the gross principal amount of loans held for investment was $375.220 million, with a weighted average contractual interest rate of 13.21%[129]. - The allowance for credit losses as of September 30, 2025, was $11.083 million, representing 3.0% of the total gross principal amount of loans held for investment[134]. - The number of loans held for investment outstanding decreased from 157 as of December 31, 2024, to 119 as of September 30, 2025[129]. - The primary markets for the company's loans held for investment included Connecticut (45.5% of loans), Florida (14.3%), and Massachusetts (8.4%) as of September 30, 2025[131]. - The aggregate gross principal amount of residential loans held for investment was $202.220 million, accounting for 53.9% of the total[132]. - The company’s loan portfolio included 54 loans of $1 million or less, representing 45.4% of the total number of loans[131]. - The weighted average term to maturity for loans held for investment increased from 4 months as of December 31, 2024, to 6 months as of September 30, 2025[129]. Financial Performance - Total revenues for the three months ended September 30, 2025, decreased by 18.8% to $12,000,000 compared to $14,785,000 for the same period in 2024[138]. - Interest income from loans fell by 27.1% to $8,326,000, while fee income from loans increased by 6.6% to $1,964,000[138]. - Net income for the three months ended September 30, 2025, was $997,000, a significant improvement from a net loss of $5,051,000 in the same period of 2024[138]. - The provision for credit losses related to loans held for investment dropped by 90.0% to $812,000 compared to $8,096,000 in 2024[138]. - Total operating expenses decreased by 36.9% to $12,367,000 from $19,607,000 in the prior year[138]. Asset and Equity Changes - Total assets decreased by $7.6 million, or 1.5%, to $484.4 million as of September 30, 2025, mainly due to a $6.9 million decrease in cash and cash equivalents[151]. - Total liabilities decreased by $1.5 million, or 0.5%, to $308.8 million as of September 30, 2025, driven by a $55.5 million reduction in notes payable[152]. - Total shareholders' equity decreased by $6.0 million, or 3.3%, to $175.6 million as of September 30, 2025, due to increased dividends paid[153]. - Book value per common share decreased to $2.47 as of September 30, 2025, down from $2.54 as of June 30, 2025[144]. - Book value per common share decreased to $2.47 as of September 30, 2025, from $2.64 at December 31, 2024, primarily due to $10.4 million in dividends paid[150]. Non-Performing Loans - The company reported a total of 104.066 million in non-performing loans as of September 30, 2025, with a direct reserve of $2.372 million[134]. - The aggregate non-performing loan balance as of September 30, 2024, was $147.0 million, an increase of $62.4 million from December 31, 2023[143]. - The aggregate non-performing loan balance increased to $147.0 million as of September 30, 2024, up $62.4 million from $84.6 million at December 31, 2023[149]. Cash and Financing Activities - Cash and cash equivalents increased by 90.0% to $11.2 million as of September 30, 2025, compared to $5.9 million at the end of the previous year[155]. - The company entered into a new Credit Agreement on March 20, 2025, with a maturity date of March 2, 2026, and had borrowed $32.7 million under this facility as of September 30, 2025[158]. - A private placement of $100.0 million in Senior Secured Notes was completed on June 11, 2025, with an initial draw of $50.0 million and an additional draw of $40.0 million in September 2025[159][160]. - The company reduced its investments in limited liability companies by $12.8 million since December 31, 2024, using returns to fund additional loans[140]. - The company has no off-balance sheet transactions that could affect liquidity or capital resource requirements[161]. Employee Compensation - Compensation and employee benefits increased by 33.8% to $2,334,000, attributed to one-time cash bonuses and additional headcount[142].
Frontdoor(FTDR) - 2025 Q3 - Quarterly Results
2025-11-05 12:05
Revenue and Growth - Revenue increased 14% to $618 million, driven by a 12% increase in volume primarily from the 2-10 acquisition and a 3% increase in price[5] - Real estate revenue increased 21% primarily due to the 2-10 acquisition[10] - Other revenue surged 73% due to growth in new HVAC and Moen programs[10] - Revenue for Q3 2025 was $618 million, a 14.4% increase from $540 million in Q3 2024[34] - Full-year revenue guidance increased to between $2.075 billion and $2.085 billion[5] Profitability - Gross profit margin improved by 60 basis points to 57%[4] - Net income rose 5% to $106 million, with diluted earnings per share increasing 9% to $1.42[5] - Adjusted EBITDA increased 18% to $195 million[5] - Gross profit for Q3 2025 reached $353 million, up from $306 million in Q3 2024, reflecting a gross margin improvement[34] - Net income for the nine months ended September 30, 2025, was $253 million, compared to $226 million for the same period in 2024, representing a 12% increase[34] - Adjusted net income for Q3 2025 was $117 million, up 10% from $106 million in Q3 2024; for the nine months, adjusted net income increased to $288 million from $240 million, representing a 20% growth[43] - Adjusted EBITDA for Q3 2025 was $195 million, a 18% increase from $165 million in Q3 2024; for the nine months, adjusted EBITDA rose to $494 million from $394 million, a growth of 25%[45] Cash Flow and Assets - Free Cash Flow for the nine months ended September 30, 2025, was $315 million, compared to $212 million in the same period of 2024, showing a significant increase[39] - Cash and cash equivalents increased to $563 million as of September 30, 2025, up from $421 million at the end of 2024[36] - Total assets grew to $2,227 million as of September 30, 2025, compared to $2,107 million at the end of 2024, indicating strong asset growth[36] - Free cash flow for the nine months ended September 30, 2025, was $296 million, a significant increase of 63% compared to $181 million in the same period of 2024[44] Shareholder Returns - Share repurchases totaled $215 million year-to-date through October 2025[5] - The company repurchased $195 million of common stock during the nine months ended September 30, 2025, compared to $120 million in the same period of 2024[39] - The weighted-average diluted shares outstanding decreased to 74.4 million in Q3 2025 from 77.1 million in Q3 2024, indicating a reduction in share dilution[34] Expenses - Selling and administrative expenses for Q3 2025 were $174 million, an increase from $154 million in Q3 2024, reflecting investment in growth[34] - The company incurred $13 million in amortization expense for Q3 2025, compared to $1 million in Q3 2024; for the nine months, amortization expense totaled $38 million versus $2 million in the prior year[43] - Restructuring charges for Q3 2025 were $1 million, down from $3 million in Q3 2024; for the nine months, restructuring charges remained at $1 million compared to $5 million in the previous year[43] Membership and Customer Metrics - Home warranty member count is expected to decline approximately 2% in 2025[16] - The number of home warranties increased to 2.11 million in 2025, reflecting an 8% growth compared to 1.95 million in 2024; customer retention rate improved to 79.4% from 77.7%[47] - First-year direct-to-consumer home warranties grew to 0.32 million in 2025, up from 0.27 million in 2024, marking an increase of 18.5%[47] Tax and Adjustments - The company reported a tax impact of adjustments of $(3) million for Q3 2025, compared to $(1) million in Q3 2024, indicating a higher tax adjustment impact year-over-year[43]
SolarEdge(SEDG) - 2025 Q3 - Quarterly Results
2025-11-05 12:05
Financial Performance - The Company reported revenues of $340.21 million for Q3 2025, an 18% increase from $289.41 million in the prior quarter[3] - Non-GAAP revenues were $339.7 million, up 21% from $281.0 million in the prior quarter[4] - Revenues for the three months ended September 30, 2025, were $340,177 thousand, a 44.5% increase from $235,435 thousand in the same period of 2024[27] - The company reported a total revenue of $2.89 billion, representing a 10.5% increase year-over-year[34] - The company provided a future outlook with a revenue guidance of $2.9 billion to $3.1 billion for the next quarter, indicating a potential growth of 5% to 7%[34] Profitability Metrics - GAAP gross margin improved to 21.2%, compared to 11.1% in the prior quarter[4] - Non-GAAP gross margin was 18.8%, up from 13.1% in the prior quarter[5] - Gross profit for the three months ended September 30, 2025, was $72,143 thousand, compared to a gross loss of $(727,794) thousand in the same period of 2024[27] - Non-GAAP gross profit for the same period was $63,922,000, with a gross margin of 18.8%, up from a gross margin of (39.4)% for the year ended December 31, 2024[33] - Operating loss (GAAP) for the three months ended September 30, 2025, was $(35,150) thousand, compared to $(115,493) thousand for the previous quarter[36] - Non-GAAP operating loss for the same period was $(23,757) thousand, down from $(48,332) thousand in the prior quarter[36] - Net loss for the three months ended September 30, 2025, was $(50,060) thousand, compared to a net loss of $(1,230,789) thousand in the same period of 2024[27] - Non-GAAP net loss was $18.3 million, down from $47.7 million in the prior quarter[10] Cash Flow and Liquidity - Cash generated from operating activities was $25.6 million, compared to a cash outflow of $7.8 million in the prior quarter[13] - Free cash flow generated was $22.8 million, compared to a free cash flow outflow of $9.1 million in the prior quarter[14] - Net cash provided by operating activities for the nine months ended September 30, 2025, was $51,632 thousand, compared to $(351,124) thousand in the same period of 2024[31] - Cash and cash equivalents increased to $439,515 thousand as of September 30, 2025, from $274,611 thousand as of December 31, 2024[29] Assets and Liabilities - Total current assets decreased to $1,767,516 thousand as of September 30, 2025, from $2,050,565 thousand as of December 31, 2024[29] - Total liabilities decreased to $1,752,550 thousand as of September 30, 2025, from $1,988,111 thousand as of December 31, 2024[29] - Total stockholders' equity decreased to $479,760 thousand as of September 30, 2025, from $658,342 thousand as of December 31, 2024[29] Operating Expenses - Operating expenses (GAAP) totaled $107,293,000 for the three months ended September 30, 2025, compared to $120,262,000 for the previous quarter[33] - Non-GAAP operating expenses were reported at $87.67 million, showing a slight decrease from the previous quarter[35] - Stock-based compensation for R&D was $10,681,000 for the three months ended September 30, 2025, compared to $15,911,000 for the previous quarter[33] - Stock-based compensation increased to $21,885 thousand from $19,261 thousand in the previous quarter[36] Strategic Initiatives - The Company expects Q4 2025 revenues to be in the range of $310 million to $340 million, with a Non-GAAP gross margin of 19% to 23%[17] - The Company plans to report key performance metrics starting Q4 2025, focusing on revenue recognition rather than products shipped[8] - New product launches contributed to a 25.42% increase in sales, with specific emphasis on the latest technology advancements[34] - Market expansion efforts have led to a 28.81% increase in international sales, highlighting the company's strategic focus on global markets[34] - The company is actively pursuing acquisitions, with a budget of $1.20 billion allocated for potential targets in the upcoming fiscal year[34] Discontinued Operations - The company experienced a significant reduction in discontinued operation revenues, reporting a loss of $85,000 for the three months ended September 30, 2025, compared to a loss of $8,132,000 for the previous quarter[33] - Total revenues from discontinued operations were $(12,870) thousand, a significant decrease from $26,771 thousand in the previous quarter[36] - The company experienced a loss from discontinued operations of $(0.23) in the latest quarter, compared to a gain of $0.50 in the previous quarter[43] Impairment and Restructuring - The company recorded a loss from impairment of private held companies amounting to $15,011 thousand, with no prior quarter comparison available[38] - Restructuring charges were $31,000 for the three months ended September 30, 2025, compared to $430,000 for the previous quarter[33] - The company reported a restructuring charge of $426 million, aimed at optimizing operational efficiency[34] - Restructuring charges for the quarter were $457 thousand, down from $877 thousand in the previous quarter[36]
Upstream Bio, Inc.(UPB) - 2025 Q3 - Quarterly Results
2025-11-05 12:05
Financial Performance - Upstream Bio reported a net loss of $33.7 million for Q3 2025, compared to a net loss of $16.0 million in Q3 2024, reflecting an increase of $17.7 million primarily due to higher research and development expenses[11]. - Upstream Bio's total operating expenses for Q3 2025 were $38.5 million, compared to $19.5 million in Q3 2024, reflecting an increase driven by research and development activities[21]. Research and Development - Research and development expenses for Q3 2025 were $33.0 million, up from $15.4 million in the same period last year, marking an increase of $17.6 million driven by clinical and manufacturing costs related to verekitug programs[9]. - The company is investing in CMC and drug delivery to enhance the clinical profile and utility of verekitug for patients[2]. Clinical Trials - Positive top-line results from the VIBRANT Phase 2 trial in chronic rhinosinusitis with nasal polyps (CRSwNP) showed a statistically significant reduction in placebo-adjusted endoscopic nasal polyp score of -1.8 (p<0.0001) after 24 weeks[3]. - Key secondary endpoints in the VIBRANT trial showed a reduction in nasal congestion score of -0.8 (p=0.0003) and a 76% (p=0.03) reduction in the need for surgery or systemic corticosteroids[7]. - Verekitug demonstrated a favorable safety profile with no serious adverse events reported during the VIBRANT trial[7]. - The VALIANT Phase 2 trial in severe asthma is on track to report top-line results in Q1 2026, with patient enrollment completed in June 2025[5]. - Enrollment is ongoing in the VENTURE Phase 2 trial for chronic obstructive pulmonary disease (COPD), with the first patient dosed in July 2025[8]. Financial Position - Cash, cash equivalents, and short-term investments totaled $372.4 million as of September 30, 2025, which is expected to fund operations through 2027[9].
EyePoint Pharmaceuticals(EYPT) - 2025 Q3 - Quarterly Results
2025-11-05 12:05
[Legal Disclaimers](index=2&type=section&id=Legal%20Disclaimers) [Summary of Disclaimers](index=2&type=section&id=Legal%20Disclaimers_Summary) This section outlines forward-looking statements, risks, and uncertainties inherent in the presentation, advising readers that actual results may differ materially from projections, referencing SEC filings for more detailed risk factors - The presentation contains forward-looking statements subject to risks and uncertainties, including clinical trial timing, regulatory approvals, manufacturing, and financial resources, as detailed in SEC filings (10-K, 10-Q)[5](index=5&type=chunk) [Company Overview & Pipeline](index=3&type=section&id=A%20Leader%20in%20Sustained%20Release%20Drug%20Delivery%20for%20Retinal%20Disease) [Company Highlights](index=3&type=section&id=A%20Leader%20in%20Sustained%20Release%20Drug%20Delivery%20for%20Retinal%20Disease_Highlights) EyePoint is a leader in sustained-release drug delivery for retinal diseases, with DURAVYU™ in Phase 3 for wet AMD and DME, supported by its Durasert® technology, experienced leadership, and a strong financial position - DURAVYU™ Phase 3 programs are underway for DME and wet AMD, with wet AMD data anticipated in **mid-2026**[7](index=7&type=chunk) - The company utilizes Durasert® delivery technology, which has a strong safety profile across multiple FDA-approved products[7](index=7&type=chunk) Financial Runway | Metric | Value | | :--- | :--- | | Cash & Equivalents (as of 9/30/25) | $200 million+ | | Runway | Into 2027 (beyond Phase 3 wet AMD data) | [Pipeline Programs](index=4&type=section&id=Pipeline%20Pursuing%20Large%20Market%20Opportunities) EyePoint's pipeline focuses on large market opportunities in retinal diseases, primarily with DURAVYU™ (vorolanib) in Phase 3 for wet AMD and DME, and EYP-2301 (razuprotafib) in pre-clinical development for other retinal diseases Durasert E™ Pipeline Programs | Program | Indication | Phase 1 | Phase 2 | Phase 3 | Anticipated Milestones | | :--- | :--- | :--- | :--- | :--- | :--- | | DURAVYU™ (vorolanib) | Wet AMD | | | LUGANO and LUCIA fully enrolled | LUGANO top mid-2026; LUCIA shortly after | | DURAVYU™ (vorolanib) | DME | | | Phase 3 planning underway | Phase 3 FPI | | EYP-2301 (razuprotafib) | Retinal diseases | | | | Tox and PK studies | - Current cash runway extends **into 2027**, covering significant milestones for DURAVYU in wet AMD[10](index=10&type=chunk) [Market Opportunity](index=5&type=section&id=DURAVYU%E2%84%A2%20is%20being%20evaluated%20in%20Wet%20AMD%20and%20DME) DURAVYU™ targets the two largest retinal disease markets, wet AMD and DME, which together represent **80%** of the **$12 billion+** global branded market for vascular retinal diseases - The global branded market for vascular retinal diseases is over **$12 billion**[11](index=11&type=chunk) Vascular Retinal Disease Market Share | Indication | Market Share (Billion $) | | :--- | :--- | | Wet AMD | $7 | | DME | $3 | | RVO | $2 | | NPDR | $0.3 | | **Total** | **$12.3+** | - Wet AMD and DME collectively account for **80%** of the branded market[12](index=12&type=chunk) [Durasert E™ Technology & DURAVYU Overview](index=6&type=section&id=Durasert%20E%E2%84%A2%3A%20The%20Next%20Generation%20in%20Sustained-Release%20Intravitreal%20Drug%20Delivery) [Durasert E™ Technology](index=6&type=section&id=Durasert%20E%E2%84%A2%3A%20The%20Next%20Generation%20in%20Sustained-Release%20Intravitreal%20Drug%20Delivery_Tech) Durasert E™ is a bioerodible, next-generation sustained-release intravitreal drug delivery technology with a proven safety profile, and DURAVYU, utilizing this technology, offers a novel multi-MOA, immediate therapeutic levels, and sustained drug release for six months or longer - Durasert E™ is a bioerodible technology with over **three decades** of innovation and proven safety across **four FDA-approved products**[14](index=14&type=chunk) - DURAVYU (vorolanib) offers a novel mechanism of action, inhibiting signaling from all VEGF isoforms at the receptor level[14](index=14&type=chunk) - DURAVYU achieves therapeutic levels **within hours** and provides consistent daily dosing with receptor inhibition for **≥6 months**[14](index=14&type=chunk) [DURAVYU Clinical Data Summary](index=7&type=section&id=DURAVYU%20Data%20Suggests%20Robust%20Efficacy%20Outcomes%20and%20a%20Strong%20Safety%20Profile%20Across%20Multiple%20Indications) DURAVYU has demonstrated robust efficacy and a strong safety profile across multiple indications in over **190 patients**, meeting primary endpoints in wet AMD and DME with disease control, fewer injections, and no safety signals DURAVYU Clinical Trial Results Summary | Trial | Phase | Indication | Key Outcomes | | :--- | :--- | :--- | :--- | | DAVIO | 1 | Wet AMD | Stable vision and OCT with 74% reduction in treatment burden | | DAVIO 2 | 2 | Wet AMD | Stable vision & strong anatomical control with >80% reduction in treatment burden | | PAVIA | 2 | NPDR | Prevented worsening of disease severity | | VERONA | 2 | DME | Rapid & sustained improvements in vision and anatomical control with fewer injections | - Primary endpoints were met in wet AMD & DME, showing disease control with fewer injections and a favorable safety and tolerability profile with no safety signals[17](index=17&type=chunk) [DURAVYU for Wet AMD](index=8&type=section&id=DURAVYU%20for%20Wet%20AMD) [Phase 3 Pivotal Program](index=9&type=section&id=DURAVYU%20in%20Wet%20AMD%3A%20LUGANO%20and%20LUCIA%3A%20Identical%20Phase%203%20Pivotal%20Trials%20Evaluating%20Non-inferiority%20vs%20On-label%20Aflibercept) The DURAVYU Phase 3 pivotal program for wet AMD, comprising identical LUGANO and LUCIA trials, is fully enrolled and on track, comparing DURAVYU **2.7mg q6M** against on-label aflibercept **2mg q8W**, with topline data for LUGANO expected **mid-2026** - Both LUGANO and LUCIA Phase 3 trials for wet AMD are fully enrolled, with topline **56-week data** for LUGANO expected in **mid-2026**[9](index=9&type=chunk)[22](index=22&type=chunk) - The trial design, informed by Phase 1 DAVIO and Phase 2 DAVIO 2 trials, has written alignment with the FDA, establishing a clear regulatory path[22](index=22&type=chunk) Phase 3 Wet AMD Trial Design (LUGANO & LUCIA) | Feature | Description | | :--- | :--- | | Design | Identical, non-inferiority pivotal trials | | Patients per trial | ~400 | | DURAVYU Dosing | 2.7 mg every 6 months (q6M) | | Comparator | Aflibercept 2 mg every 8 weeks (q8W) | | Primary Endpoint | Blended mean change in BCVA from baseline at Week 52 & Week 56 | | Supplemental Treatment | Anti-VEGF allowed based on strict prespecified criteria | [Commercial Manufacturing](index=11&type=section&id=Commercial%20Manufacturing%20Facility%20to%20Support%20DURAVYU%20through%20Potential%20NDA%20Approval%20and%20Commercial%20Launch) EyePoint has a **41,000 sq ft** commercial manufacturing facility in Northbridge, MA, built to FDA and EMA standards, with DURAVYU registration batches underway to support future NDA filing and commercial launch - A **41,000 sq ft** commercial manufacturing facility in Northbridge, MA, is built to US FDA and EU EMA standards[28](index=28&type=chunk) - DURAVYU registration batches are underway to support future NDA filing[28](index=28&type=chunk) [DURAVYU for DME: Market & Mechanism](index=12&type=section&id=DURAVYU%20for%20DME) [DME Market Opportunity & Unmet Needs](index=13&type=section&id=Diabetic%20Macular%20Edema%3A%20Large%20Market%20Opportunity%20with%20Significant%20Unmet%20Need%20for%20More%20Durable%20Treatments) Diabetic Macular Edema (DME) represents a large and growing market with significant unmet needs for more durable treatments and better inflammation control, as many patients still experience vision loss despite current therapies - **25%** of patients in the US with diabetes are projected to develop DME by **2030**[34](index=34&type=chunk) - The global branded market for DME is projected to reach **$10 billion** by **2030**[34](index=34&type=chunk) - There is an unmet need for effective, durable disease control and inflammation treatment in DME, as current therapies often lead to delayed/missed visits and vision loss[33](index=33&type=chunk)[37](index=37&type=chunk) [DME Pathogenesis: VEGF & Inflammation](index=15&type=section&id=DME%20is%20a%20Multifactorial%20Disease%20Driven%20by%20VEGF%20and%20Inflammation) DME is a multifactorial disease driven by both VEGF and inflammation, particularly IL-6, which plays a prominent role in its pathogenesis, and targeting both appears superior to VEGF blockage alone as IL-6 signaling via JAK kinases (especially JAK1) contributes to vascular leakage and neovascularization - DME is a multifactorial disease where VEGF suppression alone is insufficient; inflammation, particularly increased levels of IL-6, plays a key role[39](index=39&type=chunk)[41](index=41&type=chunk) - Dual inhibition of VEGF and IL-6 is critical for alleviating vascular leakage and inflammation, with IL-6 signaling occurring via activation of JAK kinases, especially JAK1[43](index=43&type=chunk)[45](index=45&type=chunk)[48](index=48&type=chunk) [Vorolanib's Multi-MOA in DME](index=17&type=section&id=DURAVYU%20for%20DME%3A%20Vorolanib%20provides%20multi-MOA%20functionality%20by%20inhibiting%20both%20VEGF%20and%20IL-6%20activation%20of%20inflammation) Vorolanib, the active ingredient in DURAVYU, provides multi-MOA functionality by inhibiting both VEGF and IL-6-mediated inflammation through its binding to JAK1 and other kinases relevant to retinal disease - Vorolanib provides multi-MOA functionality by inhibiting both VEGF and IL-6 activation of inflammation[49](index=49&type=chunk) - Vorolanib binds JAK1, inhibiting IL-6 activity in vitro, and targets multiple kinases of interest in retinal disease, including JAKs, TIE, PDGFR, FLT3, Kit, VEGFRs, and FGFR[50](index=50&type=chunk) [DURAVYU for DME: Clinical Data](index=18&type=section&id=DURAVYU%20in%20DME%3A%20Single%20DURAVYU%202.7mg%20Treatment%20Demonstrated%20Meaningful%20Vision%20and%20Anatomical%20Improvement%20as%20Early%20as%20Week%204) [Phase 2 VERONA Efficacy](index=18&type=section&id=DURAVYU%20in%20DME%3A%20Single%20DURAVYU%202.7mg%20Treatment%20Demonstrated%20Meaningful%20Vision%20and%20Anatomical%20Improvement%20as%20Early%20as%20Week%204_Efficacy) In the Phase 2 VERONA trial, a single **2.7mg** DURAVYU treatment demonstrated meaningful and rapid improvements in vision (BCVA) and anatomical control (CST) as early as **Week 4**, with sustained effects up to **Week 24**, outperforming aflibercept in both metrics VERONA Trial: BCVA Change from Baseline (Week 24) | Treatment | Mean Change in ETDRS Letters | | :--- | :--- | | DURAVYU 2.7mg (n=10, ex-outlier) | +10.1 | | Aflibercept 2mg (n=6) | +7.1 | VERONA Trial: CST Change from Baseline (Week 24) | Treatment | Mean Change in Microns | | :--- | :--- | | DURAVYU 2.7mg (n=10, ex-outlier) | -75.9 | | Aflibercept 2mg (n=6) | -43.7 | [Comparative Efficacy & Treatment Burden](index=19&type=section&id=DURAVYU%20in%20DME%3A%202.7%20mg%20in%20Supplement-Free%20Eyes%20Achieved%20Similar%20BCVA%20Contrasted%20to%20Anti-VEGF%20%2B%20Anti-IL-6%20Dosed%20Monthly) A single **2.7mg** DURAVYU dose, combined with a single aflibercept dose, achieved comparable BCVA improvements to monthly anti-VEGF + anti-IL-6 combination therapy (**12 injections vs. 2 injections**) in supplement-free eyes, significantly reducing treatment burden - In supplement-free eyes, a single DURAVYU **2.7mg** dose (with a single aflibercept dose) achieved comparable BCVA to monthly anti-IL6 (vamikibart) + ranibizumab, significantly reducing the number of injections (**2 vs. 12**)[56](index=56&type=chunk) [Macular Leakage Reduction](index=20&type=section&id=DURAVYU%20in%20DME%3A%20Dose-Dependent%20Reduction%20in%20Macular%20Leakage%20Area%20with%20a%20Single%20DURAVYU%20Injection) A single DURAVYU injection demonstrated a marked and dose-dependent reduction in macular leakage area at **Week 24**, a key biomarker of vascular stability in DME, with the **2.7mg** dose showing the most significant improvement Vascular Leakage Area Change from Baseline to Week 24 | Treatment | Change (mm²) | | :--- | :--- | | DURAVYU 2.7 mg (n=10) | -3.14 | | DURAVYU 1.3 mg (n=11) | -2.02 | | Aflibercept 2.0 mg (n=6) | -0.66 | - Marked reduction in leakage area at **Week 24** after a single DURAVYU **2.7 mg** dose and no supplementation, indicating improved vascular stability[58](index=58&type=chunk) [Patient Case Study](index=21&type=section&id=DURAVYU%20in%20DME%3A%20Continued%20Drying%20at%20Week%2024%20with%20Improved%20BCVA%20After%20a%20Single%20DURAVYU%202.7%20mg%20Dose%20%3A%20No%20Supplementation) A patient case study demonstrated continued fluid drying and improved BCVA (**+8 letters**) at **Week 24** after a single DURAVYU **2.7mg** dose with no supplementation, showing a more favorable response compared to prior VABYSMO treatment - A patient case showed fluid drying and vision improvement (**+8 letters BCVA**) at **Week 24** after a single DURAVYU **2.7mg** dose, with no supplementation, responding more favorably than to VABYSMO[60](index=60&type=chunk)[61](index=61&type=chunk) [DURAVYU for DME: Phase 3 Plans](index=22&type=section&id=DURAVYU%20for%20DME_Phase3) [Phase 3 Clinical Program Design](index=23&type=section&id=DURAVYU%20in%20DME%3A%20Phase%203%20Clinical%20Program%20is%20Designed%20to%20Drive%20Global%20Regulatory%20and%20Commercial%20Success) EyePoint's Phase 3 clinical program for DME, consisting of two global, randomized, double-masked, non-inferiority trials ('COMO' and 'CAPRI'), is designed to demonstrate DURAVYU's efficacy and reduced treatment burden compared to on-label aflibercept, with First Patient In (FPI) anticipated in **Q1 2026** - The Phase 3 DME program includes **two pivotal**, non-inferiority trials ('COMO' and 'CAPRI'), each with **~240 patients**, comparing **2.7mg** DURAVYU every **six months** to on-label aflibercept[65](index=65&type=chunk) - Primary endpoint is the difference in mean change in BCVA from Day 1 to **Week 52 and 56** (blended) versus aflibercept control[65](index=65&type=chunk) - First Patient In (FPI) for the DME Phase 3 trials is anticipated in **Q1 2026**, leveraging existing clinical trial infrastructure from the wet AMD program[66](index=66&type=chunk) [DME Program Summary](index=26&type=section&id=DURAVYU%E2%84%A2%3A%20The%20Only%20TKI%20in%20Development%20for%20DME) DURAVYU is positioned as the only TKI in development for DME, offering dual anti-VEGF and anti-IL-6 inhibition, with positive Phase 2 VERONA results supporting its multi-MOA approach, and Phase 3 pivotal trials expected to commence in **Q1 2026** following FDA alignment - DURAVYU is the **only TKI** in development for DME, providing **dual anti-VEGF and anti-IL-6 inhibition** to alleviate vascular leakage and inflammation[70](index=70&type=chunk) - Positive Phase 2 VERONA trial results showed early and sustained improvements in vision and anatomy, underscoring the potential clinical utility of vorolanib's multi-MOA[70](index=70&type=chunk) - Following a positive End-of-Phase 2 meeting with the FDA, initiation of Phase 3 pivotal trials in DME is expected in **Q1 2026**[70](index=70&type=chunk)
Boundless Bio, Inc.(BOLD) - 2025 Q3 - Quarterly Results
2025-11-05 12:05
Exhibit 99.1 Boundless Bio Reports Third Quarter 2025 Financial Results and Business Highlights Enrollment ongoing in BBI-355 / BBI-825 combination arm of the POTENTIATE trial Investigational new drug submission for BBI-940 on track, with a first-in-human clinical trial expected to initiate in the first half of 2026 Research and Development Highlights and Upcoming Milestones BBI-940 novel Kinesin program targeting ecDNA segregation and inheritance $118 million in cash supports operations into first half of ...