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SkyHarbour(SKYH) - 2025 Q2 - Quarterly Report
2025-08-12 20:02
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR (212) 554-5990 Registrant's telephone number, including area code ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39648 Sky Harbour Group Corporation (Exact n ...
Stoke Therapeutics(STOK) - 2025 Q2 - Quarterly Results
2025-08-12 20:01
[Stoke Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Updates](index=1&type=section&id=Stoke%20Therapeutics%20Reports%20Second%20Quarter%202025%20Financial%20Results%20and%20Provides%20Business%20Updates) [Executive Summary and CEO Commentary](index=1&type=section&id=Executive%20Summary%20and%20CEO%20Commentary) The company reported Q2 2025 results, highlighting progress in its zorevunersen and STK-002 clinical programs and a strong cash position - First patient dosed in Phase 3 EMPEROR study of zorevunersen for Dravet syndrome[1](index=1&type=chunk) - New 3-year zorevunersen OLE data show **durable reductions in seizures** and **improvements in cognition/behavior**, with good tolerability[1](index=1&type=chunk) - Phase 1 study of STK-002 initiated for Autosomal Dominant Optic Atrophy (ADOA)[1](index=1&type=chunk) - CEO highlighted strong execution, foundational understanding of zorevunersen, and expansion into ADOA with STK-002[2](index=2&type=chunk) Cash, Cash Equivalents, and Marketable Securities | As of June 30, 2025 | Amount (Millions) | | :------------------ | :---------------- | | Cash, Cash Equivalents, and Marketable Securities | $355.0 | | Anticipated Funding Period | To mid-2028 | [Recent Program Highlights](index=1&type=section&id=Recent%20Program%20Highlights) The company reported significant progress across its clinical programs, including key study initiations and positive long-term data - First patient dosed in global Phase 3 EMPEROR study of zorevunersen for Dravet syndrome, with sites initiated in the U.S., UK, Japan, and planned for Europe[6](index=6&type=chunk) - New positive findings from long-term OLE studies of zorevunersen show **substantial and durable reductions in convulsive seizure frequency** through three years, alongside continued improvements in cognition and behavior[6](index=6&type=chunk) - Phase 1 OSPREY study of STK-002 in patients with Autosomal Dominant Optic Atrophy (ADOA) is now underway[6](index=6&type=chunk) [Upcoming Anticipated Milestones](index=2&type=section&id=Upcoming%20Anticipated%20Milestones) The company plans to present additional zorevunersen data in 2025 and identify a clinical candidate for SYNGAP-1 in 2026 - Additional data from the zorevunersen clinical development program to be presented at upcoming medical congresses in 2025[6](index=6&type=chunk) - Lead optimization is underway to identify a clinical candidate for the treatment of SYNGAP-1 in 2026[6](index=6&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reported a significant increase in Q2 2025 revenue and a reduced net loss, driven by collaboration agreements Q2 2025 Financial Highlights | Metric | Q2 2025 (Thousands) | Q2 2024 (Thousands) | Change (YoY) | | :-------------------------------- | :------------------ | :------------------ | :----------- | | Revenue (Acadia Collaboration) | $10,600 | $4,800 | +120.8% | | Revenue (Biogen Collaboration) | $3,200 | $0 | N/A | | Total Revenue | $13,817 | $4,831 | +186.0% | | Net Loss | $(23,483) | $(25,695) | -8.6% | | Net Loss Per Share (Basic) | $(0.40) | $(0.46) | -13.0% | | R&D Expenses | $25,855 | $21,136 | +22.3% | | G&A Expenses | $15,262 | $13,037 | +17.1% | [Year-to-Date 2025 Financial Results](index=2&type=section&id=Year-to-Date%202025%20Financial%20Results) For the first six months of 2025, the company achieved substantial revenue growth and shifted to a net income from a net loss Year-to-Date 2025 Financial Highlights | Metric | YTD 2025 (Thousands) | YTD 2024 (Thousands) | Change (YoY) | | :-------------------------------- | :------------------- | :------------------- | :----------- | | Revenue (Acadia Collaboration) | $16,800 | $9,000 | +86.7% | | Revenue (Biogen Collaboration) | $155,600 | $0 | N/A | | Total Revenue | $172,386 | $9,048 | +1805.9% | | Net Income (Loss) | $89,397 | $(52,069) | N/A (Shift to profit) | | Net Income (Loss) Per Share (Diluted) | $1.50 | $(1.02) | N/A (Shift to profit) | | R&D Expenses | $58,531 | $43,504 | +34.5% | | G&A Expenses | $29,915 | $23,258 | +28.6% | - Increase in operating expenses for both three and six-month periods primarily relates to increases in costs associated with personnel and launch readiness expense[9](index=9&type=chunk) [Stoke Webcast and Conference Call for Analysts and Investors](index=3&type=section&id=Stoke%20Webcast%20and%20Conference%20Call%20for%20Analysts%20and%20Investors) Management will host a webcast and conference call on August 12, 2025, to discuss the financial results and business updates - Webcast and conference call for analysts and investors scheduled for **Tuesday, August 12, 2025, at 4:30 PM Eastern Time**[7](index=7&type=chunk) - Webcast available on the Investors & News section of Stoke's website; registration required for Q&A participation[7](index=7&type=chunk) [About Dravet Syndrome](index=3&type=section&id=About%20Dravet%20Syndrome) Dravet syndrome is a severe genetic epilepsy with significant unmet medical needs, affecting an estimated 38,000 people - Dravet syndrome is a severe developmental and epileptic encephalopathy caused by SCN1A gene mutations, leading to insufficient NaV1.1 protein[8](index=8&type=chunk) - Over **90% of patients experience seizures** despite current treatments, with complications leading to poor quality of life and higher SUDEP risk[8](index=8&type=chunk) Estimated Dravet Syndrome Prevalence | Region | Estimated Patients | | :----- | :----------------- | | U.S. | ~16,000 | | UK, EU-4, Japan | ~22,000 | | Total | ~38,000 | [About Zorevunersen](index=3&type=section&id=About%20Zorevunersen) Zorevunersen is an investigational antisense oligonucleotide designed to treat Dravet syndrome by increasing NaV1.1 protein production - Zorevunersen is an investigational antisense oligonucleotide designed to increase NaV1.1 protein production from the non-mutated SCN1A gene to treat Dravet syndrome[9](index=9&type=chunk)[10](index=10&type=chunk) - Aims to reduce seizure frequency and improve neurodevelopment, cognition, and behavior, with demonstrated potential for **disease modification**[10](index=10&type=chunk) - Granted **Orphan Drug, Rare Pediatric Disease, and Breakthrough Therapy Designations** by the FDA[10](index=10&type=chunk) - Stoke retains exclusive rights in the U.S., Canada, and Mexico; Biogen has exclusive rest-of-world commercialization rights under a strategic collaboration[10](index=10&type=chunk) [About Autosomal Dominant Optic Atrophy (ADOA)](index=4&type=section&id=About%20Autosomal%20Dominant%20Optic%20Atrophy%20(ADOA)) ADOA is the most common inherited optic nerve disorder, causing progressive vision loss with no currently approved treatments - ADOA is the most common inherited optic nerve disorder, causing progressive and irreversible vision loss, with **no approved treatment**[11](index=11&type=chunk) - Primarily caused by OPA1 gene mutations, leading to haploinsufficiency and affecting approximately **one in 30,000 people globally**[11](index=11&type=chunk)[12](index=12&type=chunk) - Roughly half of ADOA patients fail driving standards, and **up to 46% are legally blind**[11](index=11&type=chunk) [About STK-002](index=4&type=section&id=About%20STK-002) STK-002 is a proprietary antisense oligonucleotide in clinical development for ADOA, designed to upregulate OPA1 protein expression - STK-002 is a proprietary antisense oligonucleotide for ADOA, designed to upregulate OPA1 protein expression from the non-mutant OPA1 gene[12](index=12&type=chunk) - Believed to be the **first disease-modifying therapy for ADOA**, aiming to maintain or improve vision[12](index=12&type=chunk) - Preclinical data demonstrate proof-of-mechanism and proof-of-concept; granted **Orphan Drug designation** by the FDA[12](index=12&type=chunk) - A Phase 1 study (OSPREY) of STK-002 in patients with ADOA is now underway[6](index=6&type=chunk)[12](index=12&type=chunk) [About Stoke Therapeutics](index=4&type=section&id=About%20Stoke%20Therapeutics) Stoke Therapeutics is a biotechnology company developing RNA-based medicines to restore protein expression for genetic diseases - Stoke Therapeutics is a biotechnology company restoring protein expression using RNA medicine and its proprietary **TANGO approach**[13](index=13&type=chunk) - Develops antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels, focusing on CNS and eye diseases caused by haploinsufficiency[13](index=13&type=chunk) - Zorevunersen is the lead medicine, with proof of concept demonstrated in other organs, supporting broad potential[13](index=13&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=5&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This section outlines potential risks and uncertainties that could cause actual results to differ from forward-looking statements - Contains forward-looking statements regarding future financial results, clinical outcomes, regulatory approvals, and collaborations[15](index=15&type=chunk) - Highlights risks and uncertainties, such as ability to advance product candidates, success of collaborations, replication of clinical trial results, intellectual property protection, and funding[15](index=15&type=chunk) - Company undertakes no obligation to revise or update any forward-looking statements after the press release date[15](index=15&type=chunk) [Reference](index=5&type=section&id=Reference) This section provides the source for the Dravet syndrome prevalence estimate, citing a 2015 publication by Wu et al - Dravet syndrome prevalence estimate is based on Stoke Therapeutics' preliminary estimates, scaling annual incidence to prevalence using country-specific live birth rates and adjusted for Dravet-specific mortality[16](index=16&type=chunk) - Incidence rates published by **Wu et al., Pediatrics, 2015**, were used for the estimate[16](index=16&type=chunk) [Consolidated Balance Sheets](index=7&type=section&id=Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2025, shows a significant increase in total assets and stockholders' equity compared to year-end 2024 Consolidated Balance Sheet Highlights (Selected Items) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | Change | | :-------------------- | :------------ | :---------------- | :----- | | Cash and cash equivalents | $101,472 | $127,983 | $(26,511) | | Marketable securities - current | $146,236 | $88,916 | $57,320 | | Marketable securities - long-term | $107,256 | $29,824 | $77,432 | | Total current assets | $269,970 | $232,756 | $37,214 | | Total assets | $384,508 | $271,555 | $112,953 | | Total current liabilities | $38,678 | $40,056 | $(1,378) | | Deferred revenue - net of current portion | $9,632 | $0 | $9,632 | | Total liabilities | $49,565 | $42,534 | $7,031 | | Total stockholders' equity | $334,943 | $229,021 | $105,922 | [Consolidated Statements of Operations and Comprehensive Income (Loss)](index=8&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) The statements of operations show a shift to profitability for the six-month period driven by a substantial increase in collaboration revenue Consolidated Statements of Operations Highlights (Selected Items) | Metric (in thousands) | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :-------------------- | :------ | :------ | :------- | :------- | | Revenue | $13,817 | $4,831 | $172,386 | $9,048 | | R&D Expenses | $25,855 | $21,136 | $58,531 | $43,504 | | G&A Expenses | $15,262 | $13,037 | $29,915 | $23,258 | | Total Operating Expenses | $41,117 | $34,173 | $88,446 | $66,762 | | Income (loss) from operations | $(27,300) | $(29,342) | $83,940 | $(57,714) | | Net income (loss) | $(23,483) | $(25,695) | $89,397 | $(52,069) | | Net income (loss) per share (Diluted) | $(0.40) | $(0.46) | $1.50 | $(1.02) | [Stoke Media & Investor Contacts](index=9&type=section&id=Stoke%20Media%20%26%20Investor%20Contacts) This section provides contact information for the company's media and investor relations representatives - Contact details for Dawn Kalmar (Chief Communications Officer) and Doug Snow (Director, Communications & Investor Relations) are provided for inquiries[22](index=22&type=chunk)
Grail, Inc.(GRAL) - 2025 Q2 - Quarterly Results
2025-08-12 20:01
[Q2 2025 Financial and Business Highlights](index=1&type=section&id=I.%20Executive%20Summary%20%26%20Q2%202025%20Performance) GRAIL reported strong Q2 2025 financial improvements with increased revenue and a significantly reduced net loss, alongside key operational advancements in Galleri test adoption and positive clinical study results [Q2 2025 Financial Performance](index=1&type=section&id=I.A.%20Q2%202025%20Financial%20Performance) GRAIL reported an 11% year-over-year increase in total revenue to $35.5 million for Q2 2025, with U.S. Galleri revenue growing 21% to $34.2 million. The net loss significantly improved by 93% to $114.0 million, largely due to lower impairment charges compared to the prior year | Metric | Q2 2025 (Millions) | YoY Change | | :-------------------------------- | :------------------ | :--------- | | Total Revenue | $35.5 | +11% | | Galleri Revenue | $34.4 | +22% | | U.S. Galleri Revenue | $34.2 | +21% | | Net Loss | $(114.0) | +93% (Improvement) | | Gross Loss | $(17.8) | +1% (Improvement) | | Non-GAAP Adjusted Gross Profit | $16.1 | +1% (Increase) | | Non-GAAP Adjusted EBITDA | $(78.3) | +44% (Improvement) | - Cash, cash equivalents, restricted cash, and short-term marketable securities totaled **$606.1 million** as of June 30, 2025[3](index=3&type=chunk) [Q2 2025 Operational Highlights](index=1&type=section&id=I.B.%20Q2%202025%20Operational%20Highlights) GRAIL achieved significant operational milestones in Q2 2025, including a 29% year-over-year increase in Galleri tests sold to over 45,000. Positive top-line results from the PATHFINDER 2 study were announced, showing substantially greater additional cancer detection and higher positive predictive value compared to the first PATHFINDER study. The company also expanded access to Galleri through a new collaboration with Everlywell and adoption by Rush University System for Health - Galleri tests sold grew **29% year-over-year** to more than **45,000** in Q2 2025[1](index=1&type=chunk)[2](index=2&type=chunk) - Positive top-line performance and safety results from the PATHFINDER 2 study (first 25,578 participants) were announced in June, demonstrating substantially greater additional cancer detection and a higher positive predictive value (PPV) than the first PATHFINDER study. Specificity and cancer signal origin (CSO) accuracy were consistent with previous findings (**99.5%** and **88%**, respectively), with no serious safety concerns[2](index=2&type=chunk)[8](index=8&type=chunk) - Detailed results from the first 25,000 enrolled in PATHFINDER 2 are planned for submission for presentation at ESMO 2025 in October[1](index=1&type=chunk)[2](index=2&type=chunk) - Entered a new collaboration with Everlywell to expand access to the Galleri test, making it available for request directly on everlywell.com via prescription[8](index=8&type=chunk) - Rush University System for Health became the first health system in the Chicago-area market to offer the Galleri test in July[8](index=8&type=chunk) - Data presented at ASCO Annual Meeting in May included a 5-year follow-up analysis of the Circulating Cell-free Genome Atlas (CCGA) study, showing Galleri's preferential detection of aggressive, clinically meaningful cancers[8](index=8&type=chunk) [Company and Product Information](index=2&type=section&id=II.%20Company%20and%20Product%20Information) This section details GRAIL's mission in early cancer detection, the functionality and intended use of its Galleri multi-cancer early detection test, and its laboratory's regulatory certifications [About GRAIL](index=2&type=section&id=II.A.%20About%20GRAIL) GRAIL is a healthcare company dedicated to early cancer detection, leveraging next-generation sequencing, large-scale clinical studies, and advanced machine learning to identify multiple cancer types at earlier, more treatable stages - GRAIL's mission is to detect cancer early when it can be cured[1](index=1&type=chunk)[6](index=6&type=chunk) - The company uses next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation[6](index=6&type=chunk) - GRAIL's targeted methylation-based platform supports multi-cancer early detection, risk stratification, minimal residual disease detection, biomarker subtyping, and treatment/recurrence monitoring[6](index=6&type=chunk) [About Galleri® Test](index=3&type=section&id=II.B.%20About%20Galleri%C2%AE%20Test) The Galleri multi-cancer early detection test is a proactive blood-based screening tool that identifies DNA shed by cancer cells, helping to detect cancers that currently lack recommended screenings. It is intended for adults aged 50 or older with an elevated risk for cancer and should be used in conjunction with standard screenings - The Galleri test is a multi-cancer early detection test that uses a simple blood draw to identify DNA shed by cancer cells[9](index=9&type=chunk) - It helps screen for deadly cancers without recommended screenings, such as pancreatic, esophageal, ovarian, and liver cancers[9](index=9&type=chunk) - The test is recommended for adults with an elevated risk for cancer, such as those aged 50 or older, and should be used in addition to recommended cancer screenings[9](index=9&type=chunk) [Laboratory and Regulatory Information](index=3&type=section&id=II.C.%20Laboratory%20and%20Regulatory%20Information) GRAIL's clinical laboratory is certified under CLIA and accredited by the College of American Pathologists. While the Galleri test was developed by GRAIL for clinical purposes, it has not received clearance or approval from the U.S. Food and Drug Administration - GRAIL's clinical laboratory is certified under CLIA (Clinical Laboratory Improvement Amendments of 1988) and accredited by the College of American Pathologists[11](index=11&type=chunk) - The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration[11](index=11&type=chunk) - The Galleri test is intended for clinical purposes and is regulated under CLIA for high-complexity testing[11](index=11&type=chunk) [Condensed Consolidated Financial Statements](index=6&type=section&id=III.%20Financial%20Statements) This section provides GRAIL's condensed consolidated balance sheets and statements of operations, highlighting asset and liability changes and detailed revenue and expense figures for Q2 2025 [Condensed Consolidated Balance Sheets](index=6&type=section&id=III.A.%20Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, GRAIL reported total assets of **$2.70 billion**, a decrease from **$2.98 billion** at December 31, 2024. This change was primarily driven by a reduction in cash and cash equivalents and short-term marketable securities | Asset/Liability/Equity (Thousands) | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :------------ | :---------------- | | **Assets:** | | | | Cash and cash equivalents | $127,427 | $214,234 | | Short-term marketable securities | $475,327 | $549,236 | | Total current assets | $651,844 | $819,861 | | Intangible assets, net | $1,919,723 | $2,016,890 | | Total assets | $2,702,551 | $2,983,307 | | **Liabilities:** | | | | Total current liabilities | $70,639 | $76,925 | | Total liabilities | $387,908 | $479,902 | | **Stockholders'/Member's Equity:** | | | | Accumulated deficit | $(10,023,528) | $(9,803,330) | | Total stockholders'/member's equity | $2,314,643 | $2,503,405 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=III.B.%20Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended June 30, 2025, GRAIL's total revenue increased to **$35.5 million** from **$32.0 million** in the prior year. The net loss significantly narrowed to **$114.0 million**, a substantial improvement from **$1.59 billion** in Q2 2024, primarily due to a much lower goodwill and intangible assets impairment charge | Metric (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 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Screening revenue | $34,379 | $28,163 | $63,512 | $51,702 | | Development services revenue | $1,165 | $3,807 | $3,869 | $6,989 | | Total revenue | $35,544 | $31,970 | $67,381 | $58,691 | | Cost of screening revenue | $19,346 | $15,789 | $36,469 | $29,511 | | Cost of development services revenue | $501 | $621 | $1,672 | $2,057 | | Cost of revenue — amortization of intangible assets | $33,472 | $33,472 | $66,944 | $66,944 | | Research and development | $46,626 | $94,196 | $100,251 | $195,821 | | Sales and marketing | $28,539 | $40,989 | $63,518 | $87,808 | | General and administrative | $37,914 | $67,258 | $82,988 | $124,327 | | Goodwill and intangible assets impairment | $28,000 | $1,420,936 | $28,000 | $1,420,936 | | Total costs and operating expenses | $194,398 | $1,673,261 | $379,842 | $1,927,404 | | Loss from operations | $(158,854) | $(1,641,291) | $(312,461) | $(1,868,713) | | Net loss | $(113,985) | $(1,585,337) | $(220,198) | $(1,804,251) | | Net loss per share — Basic and Diluted | $(3.18) | $(51.06) | $(6.28) | $(58.11) | [Non-GAAP Financial Measures Reconciliation](index=3&type=section&id=IV.%20Non-GAAP%20Financial%20Measures%20Reconciliation) This section explains GRAIL's use of non-GAAP financial measures, Adjusted Gross Profit and Adjusted EBITDA, and provides detailed reconciliations to their most directly comparable GAAP measures [Non-GAAP Disclosure](index=3&type=section&id=IV.A.%20Non-GAAP%20Disclosure) GRAIL uses non-GAAP financial measures, Adjusted Gross Profit (Loss) and Adjusted EBITDA, to provide investors with a clearer view of its operational and financial performance by excluding certain non-recurring or non-cash items, such as amortization of intangible assets and acquisition-related costs - Adjusted Gross Profit (Loss) is used to assess operational performance, reflecting gross profitability by excluding amortization of intangible assets and stock-based compensation allocated to cost of revenue[12](index=12&type=chunk) - Adjusted EBITDA is used to assess financial performance and for internal planning, providing a comparable overview across historical periods by excluding interest, taxes, depreciation, impairment, acquisition-related legal fees, restructuring charges, and stock-based compensation[12](index=12&type=chunk)[13](index=13&type=chunk) [Adjusted Gross Profit Reconciliation](index=8&type=section&id=IV.B.%20Adjusted%20Gross%20Profit%20Reconciliation) For Q2 2025, Adjusted Gross Profit was **$16.1 million**, a slight increase from **$16.0 million** in Q2 2024. This was calculated by adjusting the GAAP gross loss of **$(17.8) million** by adding back amortization of intangible assets and stock-based compensation | Metric (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 | | :------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Gross loss | $(17,775) | $(17,912) | $(37,704) | $(39,821) | | Amortization of intangible assets | $33,472 | $33,472 | $66,944 | $66,944 | | Stock-based compensation | $417 | $463 | $1,179 | $944 | | Adjusted Gross Profit | $16,114 | $16,023 | $30,419 | $28,067 | [Adjusted EBITDA Reconciliation](index=9&type=section&id=IV.C.%20Adjusted%20EBITDA%20Reconciliation) GRAIL's Adjusted EBITDA for Q2 2025 was **$(78.3) million**, a significant improvement from **$(139.4) million** in Q2 2024. This improvement is largely attributed to the substantial reduction in goodwill and intangible impairment charges compared to the prior year | Metric (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 | | :-------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(113,985) | $(1,585,337) | $(220,198) | $(1,804,251) | | Interest income | $(6,809) | $(2,805) | $(14,588) | $(5,706) | | Benefit from income tax expense | $(38,871) | $(53,144) | $(79,070) | $(58,709) | | Amortization of intangible assets | $34,583 | $34,583 | $69,167 | $69,167 | | Depreciation | $4,592 | $4,805 | $9,287 | $10,218 | | Goodwill and intangible impairment | $28,000 | $1,420,936 | $28,000 | $1,420,936 | | Illumina/GRAIL merger & divestiture legal and professional services costs | — | $15,624 | — | $21,932 | | Stock-based compensation | $14,168 | $25,947 | $30,379 | $55,053 | | Restructuring | — | — | $(34) | — | | Adjusted EBITDA | $(78,322) | $(139,391) | $(177,057) | $(291,360) | [Additional Information](index=2&type=section&id=V.%20Additional%20Information) This section provides details on GRAIL's Q2 2025 conference call, important disclaimers regarding forward-looking statements, and contact information for corporate communications and investor relations [Conference Call and Webcast](index=2&type=section&id=V.A.%20Conference%20Call%20and%20Webcast) GRAIL hosted a conference call and webcast on August 12, 2025, to discuss its Q2 2025 financial results, with a replay available on its investor relations website for 30 days - A webcast and conference call were held on August 12, 2025, at 1:30 p.m. PT / 4:30 p.m. ET[4](index=4&type=chunk) - Access to the conference call and webcast replay is available on the investor relations section of GRAIL's website (investors.grail.com)[4](index=4&type=chunk)[5](index=5&type=chunk) [Forward-Looking Statements](index=5&type=section&id=V.B.%20Forward-Looking%20Statements) The press release contains forward-looking statements subject to various risks, uncertainties, and assumptions, including future financial performance, product development, and regulatory compliance. Readers are cautioned that actual results may differ materially, and GRAIL undertakes no obligation to update these statements - Statements are forward-looking and subject to risks, uncertainties, and assumptions, including future financial performance, tests, patient awareness, clinical studies, and regulatory compliance[15](index=15&type=chunk) - Important factors could cause actual results to differ materially and adversely from those expressed, as discussed in the 'Risk Factors' sections of the Annual Report on Form 10-K and Quarterly Report on Form 10-Q[16](index=16&type=chunk) - GRAIL undertakes no obligation to update any forward-looking statements after the date of the press release, except as required by law[17](index=17&type=chunk) [GRAIL Contacts](index=5&type=section&id=V.C.%20GRAIL%20Contacts) Contact information for GRAIL's corporate communications and investor relations teams is provided for inquiries - Corporate Communications contacts are Kristen Davis and Trish Rowland (pr@grail.com)[18](index=18&type=chunk) - Investor Relations contacts are Alex Dobbin and Alexis Tosti (ir@grail.com)[18](index=18&type=chunk)
CVD(CVV) - 2025 Q2 - Quarterly Report
2025-08-12 20:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from ____ to _____ Commission file number: 1-16525 CVD EQUIPMENT CORPORATION (Name of Registrant in Its Charter) New York 11-2621692 State or Other Jurisdiction of I ...
Inovio Pharmaceuticals(INO) - 2025 Q2 - Quarterly Report
2025-08-12 20:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO COMMISSION FILE NO. 001-14888 INOVIO PHARMACEUTICALS, INC. (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) Delaware 33-0969592 (State or other jurisdiction of i ...
SEELAS Life Sciences (SLS) - 2025 Q2 - Quarterly Report
2025-08-12 20:00
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 (State of incorporation) (I.R.S. Employer Identification No.) 7 Times Square, Suite 2503, New York, NY 10036 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 00 ...
Vine Hill Capital Investment Corp.(VCICU) - 2025 Q2 - Quarterly Report
2025-08-12 20:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 001-42267 VINE HILL CAPITAL INVESTMENT CORP. (Exact name of registrant as specified in its charter) | Cayman Islands | 98-17 ...
Cue Biopharma(CUE) - 2025 Q2 - Quarterly Report
2025-08-12 20:00
PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for the period ended June 30, 2025, show an increase in cash and total assets, primarily driven by financing activities, with the company continuing to incur net losses, reporting a loss of $20.7 million for the six months ended June 30, 2025, and notes highlight substantial doubt about the company's ability to continue as a going concern due to recurring losses and the need for additional capital [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, the company's total assets increased to $40.7 million from $32.2 million at year-end 2024, primarily due to a rise in cash and cash equivalents, while total liabilities also grew to $22.5 million from $14.7 million, largely driven by an increase in research and development contract liability, and total stockholders' equity saw a slight increase to $18.2 million Condensed Consolidated Balance Sheets (in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Current Assets** | | | | Cash and cash equivalents | $27,492 | $22,459 | | Total current assets | $30,844 | $25,138 | | **Total assets** | **$40,707** | **$32,191** | | **Current Liabilities** | | | | Research and development contract liability, current portion | $9,579 | $85 | | Total current liabilities | $19,254 | $13,689 | | **Total liabilities** | **$22,548** | **$14,692** | | **Total stockholders' equity** | **$18,159** | **$17,499** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the six months ended June 30, 2025, collaboration revenue decreased to $3.4 million from $4.4 million year-over-year, total operating expenses were reduced to $24.3 million from $27.4 million, primarily due to lower research and development costs, and consequently, the net loss for the six-month period narrowed to $20.7 million from $22.5 million in the prior year Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | Collaboration revenue | $2,954 | $2,658 | $3,374 | $4,375 | | Research and development | $7,910 | $9,530 | $16,457 | $19,729 | | Total operating expenses | $11,589 | $13,041 | $24,309 | $27,426 | | Loss from operations | $(8,635) | $(10,383) | $(20,935) | $(23,051) | | **Net loss** | **$(8,482)** | **$(10,171)** | **$(20,739)** | **$(22,518)** | | Net loss per common share | $(0.09) | $(0.24) | $(0.20) | $(0.45) | [Condensed Consolidated Statements of Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) For the six months ended June 30, 2025, stockholders' equity increased from $17.5 million to $18.2 million, driven by the issuance of common stock, warrants, and pre-funded warrants, which provided net proceeds of $18.8 million, offset by a net loss of $20.7 million and balanced by stock-based compensation - During the first six months of 2025, the company raised approximately **$18.8 million** through the issuance of common stock, warrants, and pre-funded warrants, net of costs[23](index=23&type=chunk) - The accumulated deficit increased by **$20.7 million** during the first half of 2025, reaching **$362.6 million** due to continued net losses[23](index=23&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities was $11.6 million, a significant improvement from $19.8 million in the same period of 2024, while net cash provided by financing activities was $16.8 million, primarily from stock offerings, leading to a net increase in cash of $5.0 million, compared to a net decrease of $18.5 million in the prior year period Summary of Cash Flows (in thousands) | | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | | Net cash used in operating activities | $(11,587) | $(19,774) | | Net cash used in investing activities | $(177) | $(65) | | Net cash provided by financing activities | $16,798 | $1,354 | | **Net increase (decrease) in cash** | **$5,034** | **$(18,485)** | | Cash at end of period | $27,645 | $30,180 | [Notes to the Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) The notes detail significant accounting policies and provide context for the financial statements, including the company's conclusion that there is substantial doubt about its ability to continue as a going concern, details of recent financing activities including an $18.0 million offering in April 2025, and information on collaboration agreements, notably a new agreement with Boehringer Ingelheim (BI) which included a $10.1 million upfront payment - The company's recurring losses and negative cash flows from operations raise substantial doubt about its ability to continue as a going concern within one year[31](index=31&type=chunk) - In April 2025, the company completed an underwritten public offering, receiving net proceeds of **$18.0 million** from the sale of shares and warrants[38](index=38&type=chunk) - The company entered into a collaboration and license agreement with Boehringer Ingelheim (BI) in April 2025, receiving an upfront payment of **$10.1 million** (net of withholding taxes) and recognizing **$2.9 million** in revenue for the quarter[123](index=123&type=chunk)[125](index=125&type=chunk)[127](index=127&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=36&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's strategic focus on its autoimmune disease pipeline (CUE-401 and CUE-500 series) while seeking partners for its oncology assets (CUE-100 series), with the analysis of financial results showing a decrease in net loss driven by lower R&D spending, and the company's liquidity position detailed, with existing cash expected to fund operations into the second quarter of 2026, which raises substantial doubt about its ability to continue as a going concern without additional financing [Overview and Plan of Operation](index=36&type=section&id=Overview%20and%20Plan%20of%20Operation) Cue Biopharma is a clinical-stage company developing therapeutics for autoimmune disease and cancer using its Immuno-STAT® platform, strategically prioritizing its autoimmune programs, including CUE-401 and the CUE-500 series, while seeking collaborations for its CUE-100 series oncology assets, with a plan to file an IND for CUE-401 in Q2 2026 and leverage partnerships, such as the recent agreement with Boehringer Ingelheim for CUE-501 - The company is prioritizing its autoimmune programs, **CUE-401** and the **CUE-500 series**, over its **CUE-100 series** oncology programs[8](index=8&type=chunk)[164](index=164&type=chunk) - Cue Biopharma plans to file an Investigational New Drug (IND) application for its autoimmune candidate **CUE-401** in the second quarter of 2026[157](index=157&type=chunk)[166](index=166&type=chunk) - The company is actively seeking collaborations for its oncology assets, **CUE-101** and **CUE-102**, to fund the advancement of its autoimmune pipeline[168](index=168&type=chunk) [Results of Operations](index=48&type=section&id=Results%20of%20Operations) For the six months ended June 30, 2025, collaboration revenue decreased by $1.0 million year-over-year due to the timing of activities under different collaboration agreements, research and development expenses fell by $3.3 million, primarily from reduced clinical trial costs for the CUE-100 series, and general and administrative expenses remained relatively flat, resulting in a lower net loss of $20.7 million compared to $22.5 million in the prior-year period Comparison of Results of Operations (in thousands) | | Six Months Ended June 30, | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | | **2025** | **2024** | | | | Collaboration revenue | $3,374 | $4,375 | $(1,001) | -22.9% | | Research and development | $16,457 | $19,729 | $(3,272) | -16.6% | | General and administrative | $7,852 | $7,697 | $155 | +2.0% | | **Net loss** | **$(20,739)** | **$(22,518)** | **$1,779** | **-7.9%** | - The decrease in R&D expenses was primarily due to reduced clinical trial costs for the **CUE-100 series** as activities shifted to patient survival monitoring[207](index=207&type=chunk) [Liquidity and Capital Resources](index=49&type=section&id=Liquidity%20and%20Capital%20Resources) The company's primary sources of liquidity are equity offerings and collaboration payments, with cash and cash equivalents of $27.5 million as of June 30, 2025, which management believes will support operations into Q2 2026, but this runway of less than 12 months raises substantial doubt about the company's ability to continue as a going concern, necessitating additional capital raising, with recent financing including an $18.0 million net proceeds from an offering in April 2025 and sales under an ATM program - The company's existing cash and cash equivalents of **$27.5 million** as of June 30, 2025, are expected to fund operations into the second quarter of 2026[16](index=16&type=chunk)[225](index=225&type=chunk) - The company's limited cash runway raises substantial doubt about its ability to continue as a going concern, necessitating additional capital raising[219](index=219&type=chunk)[225](index=225&type=chunk) - In April 2025, the company raised approximately **$18.0 million** in net proceeds from an underwritten public offering of common stock and warrants[218](index=218&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=55&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Cue Biopharma is not required to provide the information for this item - The company is not required to provide quantitative and qualitative disclosures about market risk as it qualifies as a smaller reporting company[231](index=231&type=chunk) [Item 4. Controls and Procedures](index=55&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the principal executive and financial officers, evaluated the company's disclosure controls and procedures and concluded they were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - The company's principal executive officer and principal financial officer concluded that disclosure controls and procedures were effective as of June 30, 2025[233](index=233&type=chunk) - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[235](index=235&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=56&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - As of the reporting date, the company is not involved in any material legal proceedings[237](index=237&type=chunk) [Item 1A. Risk Factors](index=56&type=section&id=Item%201A.%20Risk%20Factors) This section highlights significant risks to the business, with the primary risk being the substantial doubt regarding the company's ability to continue as a going concern due to recurring losses and the need for additional capital, and other key risks including potential delisting from Nasdaq for failing to meet the minimum bid price requirement, and uncertainties related to U.S. trade policy and changes in tax laws - The company's recurring losses and need for additional capital raise substantial doubt about its ability to continue as a going concern[239](index=239&type=chunk) - On May 12, 2025, the company received a deficiency notice from Nasdaq for failing to maintain a minimum bid price of **$1.00** per share, posing a risk of delisting[247](index=247&type=chunk) - Uncertainty surrounding U.S. trade policy, including tariffs, could negatively impact material costs and supply chains[241](index=241&type=chunk)[244](index=244&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=59&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[252](index=252&type=chunk) [Item 5. Other Information](index=59&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the quarterly period - No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement during the quarter[255](index=255&type=chunk) [Item 6. Exhibits](index=60&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including certifications and amendments to agreements - The report includes a list of exhibits filed, such as the Second Amendment to the License Agreement with MIL 40G, LLC, and various required certifications[257](index=257&type=chunk)
Vine Hill Capital Investment Corp.(VCIC) - 2025 Q2 - Quarterly Report
2025-08-12 20:00
Washington, D.C. 20549 UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 001-42267 VINE HILL CAPITAL INVESTMENT CORP. (Exact name of registrant as specified in its charter) | Cayman Islands | 98-17 ...
CVD(CVV) - 2025 Q2 - Quarterly Results
2025-08-12 20:00
enabling tomorrow's technologies™ 355 South Technology Drive, Central Islip, New York 11722 | T 631.981.7081 | info@cvdequipment.com CVD Equipment Corporation Reports Second Quarter 2025 Financial Results CENTRAL ISLIP, N.Y., (Business Wire) – August 12, 2025 - CVD Equipment Corporation (NASDAQ: CVV), today announced its financial results for the second quarter ended June 30, 2025. Second Quarter 2025 Financial Performance Exhibit 99.1 Second Quarter 2025 Operational Performance Manny Lakios, President and ...