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Acasti Pharma(ACST) - 2026 Q1 - Quarterly Results
2025-08-12 12:00
[Executive Summary & Business Update](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Update) [Overview and Key Announcements](index=1&type=section&id=Overview%20and%20Key%20Announcements) Grace Therapeutics submitted GTx-104 NDA for aSAH to FDA, backed by positive Phase 3 STRIVE-ON data - Grace Therapeutics submitted an NDA to the FDA for GTx-104 for aSAH, marking a significant milestone for the company's clinical and corporate objectives[2](index=2&type=chunk)[3](index=3&type=chunk) - The GTx-104 NDA is supported by positive Phase 3 STRIVE-ON safety trial data, which met its primary endpoint and demonstrated improved clinical outcomes for aSAH patients, along with potential medical and pharmacoeconomic benefits[2](index=2&type=chunk)[3](index=3&type=chunk) - CEO Prashant Kohli stated that GTx-104 could be a potential breakthrough for aSAH patient care, as standard treatments have seen no significant innovation in nearly 40 years[3](index=3&type=chunk) [First Quarter 2026 Corporate Highlights](index=1&type=section&id=First%20Quarter%202026%20Corporate%20Highlights) Q1 highlights include GTx-104 NDA submission to FDA, potential **$7.6 million** warrant exercises, and Orphan Drug Designation - The company submitted GTx-104's NDA to the FDA, which includes positive data from the Phase 3 STRIVE-ON safety trial, demonstrating GTx-104's clinical benefits over oral nimodipine[6](index=6&type=chunk) - The NDA submission may trigger the exercise of warrants from the September 2023 private placement, potentially generating up to **$7.6 million** at an exercise price of **$3.003 per share**[6](index=6&type=chunk) - GTx-104 has received FDA Orphan Drug Designation, which, if approved, typically grants seven years of marketing exclusivity in the US market, with additional protection from US and international patents[6](index=6&type=chunk) [Financial Performance](index=1&type=section&id=Financial%20Performance) [First Quarter 2026 Financial Results](index=1&type=section&id=First%20Quarter%202026%20Financial%20Results) Grace Therapeutics reported a **$3.4 million** net loss for Q1 FY2026, an **$0.8 million** increase year-over-year, driven by derivative warrant liability changes and reduced tax benefits First Quarter 2026 Key Financial Data | Metric | June 30, 2025 ($ in thousands) | June 30, 2024 ($ in thousands) | Change ($ in thousands) | Change Rate | | :--------------------------------- | :----------------------------- | :----------------------------- | :---------------------- | :---------- | | Net Loss | (3,362) | (2,617) | (745) | 28.47% | | Basic and Diluted Loss Per Share | (0.21) | (0.24) | 0.03 | -12.50% | | Research and Development Expenses | (955) | (2,708) | 1,753 | -64.73% | | General and Administrative Expenses | (2,135) | (2,255) | 120 | -5.32% | | Change in Fair Value of Derivative Warrant Liability | (487) | 1,395 | (1,882) | -134.91% | | Income Tax Benefit | — | 724 | (724) | -100.00% | - Research and development expenses decreased by **$1.8 million** year-over-year, primarily due to the completion of the GTx-104 pivotal Phase 3 STRIVE-ON safety clinical trial, partially offset by increased professional fees related to NDA preparation and submission[7](index=7&type=chunk) - General and administrative expenses decreased by **$0.1 million** year-over-year, mainly due to reduced legal, accounting, tax, audit, and other professional fees related to the continuation and domestication completed in October 2024, partially offset by increased payroll and benefits and GTx-104 commercial assessment costs[8](index=8&type=chunk) [Cash Position and Runway](index=2&type=section&id=Cash%20Position%20and%20Runway) As of June 30, 2025, cash and cash equivalents were **$20 million**, a **$2.1 million** decrease, with existing funds projected to cover operations for at least twelve months, extending to Q2 2027 upon warrant exercise Cash and Cash Equivalents | Metric | June 30, 2025 ($ in thousands) | March 31, 2025 ($ in thousands) | Change ($ in thousands) | Change Rate | | :----------------- | :----------------------------- | :----------------------------- | :---------------------- | :---------- | | Cash and Cash Equivalents | 20,005 | 22,133 | (2,128) | -9.61% | - Common stock warrants from the February 2025 private placement, if exercised, could generate aggregate proceeds of **$15 million** at an exercise price of **$3.395 per share**[10](index=10&type=chunk) - Common stock warrants from the September 2023 private placement, if exercised, could generate aggregate proceeds of **$7.6 million** at an exercise price of **$3.003 per share**[11](index=11&type=chunk) - The company anticipates that its existing cash and cash equivalents will provide a cash runway for at least the next twelve months, extending to the second quarter of 2027 if all warrants are exercised[12](index=12&type=chunk) [Product Pipeline & Clinical Development](index=2&type=section&id=Product%20Pipeline%20%26%20Clinical%20Development) [GTx-104 and STRIVE-ON Trial Details](index=2&type=section&id=GTx-104%20and%20STRIVE-ON%20Trial%20Details) The STRIVE-ON trial, comparing GTx-104 to oral nimodipine in aSAH patients, met its primary endpoint, showing GTx-104 reduced clinically significant hypotension by **19%** and demonstrated superior or comparable outcomes in other key metrics - The STRIVE-ON trial was a prospective, randomized, open-label study comparing GTx-104 to oral nimodipine in 102 hospitalized aSAH patients (50 in the GTx-104 arm, 52 in the oral nimodipine arm)[13](index=13&type=chunk) - The trial met its primary endpoint, with GTx-104 patients experiencing a **19%** reduction in clinically significant hypotension (28% vs 35%) and superior performance in relative dose intensity (RDI ≥ 95%: 54% vs 8%) and 90-day good functional outcomes (29% more patients)[13](index=13&type=chunk) - GTx-104 patients had fewer ICU readmissions, ICU days, and ventilator days compared to the oral nimodipine group, with comparable adverse events and no new safety concerns, as all deaths were related to the severity of the patients' underlying conditions[13](index=13&type=chunk) [Disease Background: aneurysmal Subarachnoid Hemorrhage (aSAH)](index=3&type=section&id=Disease%20Background%3A%20aneurysmal%20Subarachnoid%20Hemorrhage%20(aSAH)) aSAH is a relatively rare stroke type, accounting for **5%** of all strokes, with approximately **42,500** US hospitalizations annually, primarily caused by ruptured brain aneurysms - aSAH is bleeding into the subarachnoid space on the brain's surface, primarily caused by a ruptured brain aneurysm[14](index=14&type=chunk) - aSAH is a relatively rare type of stroke, accounting for approximately **5%** of all strokes, with about **42,500** US patients hospitalized annually[14](index=14&type=chunk) [Grace Therapeutics Asset Portfolio](index=3&type=section&id=Grace%20Therapeutics%20Asset%20Portfolio) Grace Therapeutics' portfolio includes GTx-104, GTx-102, and GTx-101, with GTx-104 as the core focus for aSAH, while further development of GTx-102 and GTx-101 has been deprioritized for potential out-licensing or sale [GTx-104 (aSAH)](index=3&type=section&id=GTx-104%20(aSAH)) GTx-104 is a novel injectable nimodipine formulation using nanoparticle technology for intravenous infusion, addressing unmet needs in aSAH patients by potentially eliminating nasogastric tube administration, reducing food effects and drug interactions, and better managing hypotension - GTx-104 is a novel injectable formulation of nimodipine, utilizing unique nanoparticle technology for standard peripheral intravenous infusion, designed to address significant unmet medical needs in aSAH patients[15](index=15&type=chunk) - GTx-104 offers convenient intravenous administration, potentially eliminating the need for nasogastric tube administration in comatose or dysphagic patients, and may reduce food effects, drug interactions, and medication errors[16](index=16&type=chunk) - GTx-104 has been administered to over **200** patients and healthy volunteers, demonstrating good tolerability, significantly reduced inter- and intra-subject pharmacokinetic variability compared to oral nimodipine, and the potential for better management of hypotension in aSAH patients[16](index=16&type=chunk) [GTx-102 (Ataxia-Telangiectasia)](index=3&type=section&id=GTx-102%20(Ataxia-Telangiectasia)) GTx-102 is a novel, concentrated betamethasone oral mucosal spray for neurological symptoms of Ataxia-Telangiectasia (A-T), a condition with no FDA-approved therapies, though its development has been deprioritized to focus on GTx-104 - GTx-102 is a novel, concentrated betamethasone oral mucosal spray designed to improve neurological symptoms of Ataxia-Telangiectasia (A-T), for which there are currently no FDA-approved therapies[17](index=17&type=chunk) - The FDA has provided guidance on the NDA pathway for GTx-102, including design recommendations for a pivotal efficacy and safety trial[17](index=17&type=chunk) - Further development of GTx-102 has been deprioritized to focus on GTx-104 development, and the company may also consider out-licensing or selling GTx-102[17](index=17&type=chunk) [GTx-101 (Postherpetic Neuralgia)](index=3&type=section&id=GTx-101%20(Postherpetic%20Neuralgia)) GTx-101 is a non-narcotic, topical bio-adhesive film-forming bupivacaine spray for Postherpetic Neuralgia (PHN) symptom relief, offering rapid onset and up to eight hours of sustained analgesia, with its development deprioritized to focus on GTx-104 - GTx-101 is a non-narcotic, topical bio-adhesive film-forming bupivacaine spray designed to relieve symptoms in patients with Postherpetic Neuralgia (PHN)[18](index=18&type=chunk) - Administered via a metered spray, GTx-101 forms a thin, bio-adhesive topical film on the skin surface, offering a touch-free, non-greasy application with the potential for rapid onset and up to eight hours of sustained analgesia[18](index=18&type=chunk) - Further development of GTx-101 has been deprioritized to focus on GTx-104 development, and the company may also consider out-licensing or selling GTx-101[18](index=18&type=chunk) [Company Information](index=3&type=section&id=Company%20Information) [About Grace Therapeutics](index=3&type=section&id=About%20Grace%20Therapeutics) Grace Therapeutics is a late-stage biopharmaceutical company focused on developing drug candidates for rare and orphan diseases, leveraging novel drug delivery technologies to enhance existing drug performance - Grace Therapeutics is a late-stage biopharmaceutical company focused on developing drug candidates for rare and orphan diseases[19](index=19&type=chunk) - The company's novel drug delivery technologies aim to improve the performance of existing drugs, enabling faster onset, enhanced efficacy, reduced side effects, and more convenient drug delivery[19](index=19&type=chunk) - Grace Therapeutics' primary clinical assets, including GTx-104, have received FDA Orphan Drug Designation, providing seven years of US market exclusivity, and are protected by over **40** issued and pending patents for additional intellectual property protection[19](index=19&type=chunk) [Disclaimers & Financial Statements](index=4&type=section&id=Disclaimers%20%26%20Financial%20Statements) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements involving known and unknown risks, uncertainties, and other factors that could cause Grace Therapeutics' actual results to differ materially from historical results or future results expressed or implied by such statements - Statements in this press release constitute "forward-looking statements," involving known and unknown risks, uncertainties, and other factors that could cause actual results to differ materially from expectations[21](index=21&type=chunk) - Forward-looking statements are based on Grace Therapeutics' current expectations and assumptions, which may not be realized or prove to be incorrect, and readers should not place undue reliance on these statements[21](index=21&type=chunk) - The company undertakes no obligation to update such statements to reflect events or circumstances occurring after the date of their release, unless required by applicable securities laws[21](index=21&type=chunk) [Contact Information](index=4&type=section&id=Contact%20Information) Contact details are provided for Grace Therapeutics CEO Prashant Kohli and Investor Relations via LifeSci Advisors, including phone numbers and email addresses - Grace Therapeutics contact: Prashant Kohli, CEO, Phone: **609-322-1602**, Email: info@gracetx.com[22](index=22&type=chunk) - Investor Relations contact: Mike Moyer, Managing Director, LifeSci Advisors, Phone: **617-308-4306**, Email: mmoyer@lifesciadvisors.com[22](index=22&type=chunk) [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Grace Therapeutics' total assets were **$69,805 thousand**, a decrease from **$71,993 thousand** on March 31, 2025, driven by reduced cash and cash equivalents, and increased derivative warrant liabilities and trade and other payables Condensed Consolidated Balance Sheets (Unaudited) | (in thousands of USD, except share data) | June 30, 2025 | March 31, 2025 | | :--------------------------------- | :------------ | :------------- | | **Assets** | | | | Cash and cash equivalents | 20,005 | 22,133 | | Accounts receivable | 20 | 126 | | Prepaid expenses | 500 | 453 | | **Total Current Assets** | **20,525** | **22,712** | | Equipment, net | 14 | 15 | | Intangible assets | 41,128 | 41,128 | | Goodwill | 8,138 | 8,138 | | **Total Assets** | **69,805** | **71,993** | | **Liabilities and Stockholders' Equity** | | | | Trade and other payables | 2,315 | 1,930 | | **Total Current Liabilities** | **2,315** | **1,930** | | Derivative warrant liability | 1,628 | 1,141 | | Deferred tax liability | 2,312 | 2,312 | | **Total Liabilities** | **6,255** | **5,383** | | Additional paid-in capital | 293,636 | 293,334 | | Accumulated other comprehensive loss | (6,038) | (6,038) | | Accumulated deficit | (224,049) | (220,687) | | **Total Stockholders' Equity** | **63,550** | **66,610** | | **Total Liabilities and Stockholders' Equity** | **69,805** | **71,993** | [Condensed Consolidated Statements of Loss and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Loss%20and%20Comprehensive%20Loss) For the three months ended June 30, 2025, Grace Therapeutics reported a net loss of **$3,362 thousand**, compared to a net loss of **$2,617 thousand** in the prior year, with the increased loss primarily due to a shift from gain to loss in derivative warrant liability fair value and the absence of an income tax benefit, despite reduced R&D and G&A expenses Condensed Consolidated Statements of Loss and Comprehensive Loss (Unaudited) | (in thousands of USD, except share and per share data) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | | **Operating Expenses** | | | | Research and development expenses | (955) | (2,708) | | General and administrative expenses | (2,135) | (2,255) | | **Loss from Operations** | **(3,090)** | **(4,963)** | | Foreign exchange gain (loss) | 10 | (8) | | Change in fair value of derivative warrant liability | (487) | 1,395 | | Interest and other income, net | 205 | 235 | | Other (expense) income, net | (272) | 1,622 | | **Loss Before Income Tax Benefit** | **(3,362)** | **(3,341)** | | Income tax benefit | — | 724 | | **Net Loss and Total Comprehensive Loss** | **(3,362)** | **(2,617)** | | Basic and diluted loss per share | (0.21) | (0.24) | | Weighted average shares outstanding | 15,924,522 | 10,928,543 |
Orchestra BioMed (OBIO) - 2025 Q2 - Quarterly Report
2025-08-12 12:00
[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) Orchestra BioMed's H1 2025 financials show decreased assets, a **$38.1 million** net loss, and **$32.1 million** cash used in operations [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$42.8 million** by June 30, 2025, from **$76.2 million** at year-end 2024, mainly due to reduced cash and marketable securities Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $18,749 | $22,261 | | Marketable securities | $15,175 | $44,551 | | Total current assets | $35,882 | $69,171 | | **Total Assets** | **$42,825** | **$76,173** | | **Liabilities & Equity** | | | | Total current liabilities | $17,061 | $16,207 | | Total Liabilities | $42,530 | $43,215 | | Accumulated deficit | $(347,996) | $(309,878) | | **Total Stockholders' Equity** | **$295** | **$32,958** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net losses for Q2 and H1 2025 increased to **$19.4 million** and **$38.1 million**, driven by a **35% rise in R&D expenses** Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $836 | $778 | $1,704 | $1,398 | | Research and development | $13,853 | $11,126 | $27,335 | $20,238 | | Selling, general and administrative | $6,264 | $6,467 | $12,527 | $12,364 | | Loss from operations | $(19,327) | $(16,859) | $(38,248) | $(31,282) | | **Net loss** | **$(19,363)** | **$(15,980)** | **$(38,118)** | **$(29,443)** | | Net loss per share (basic and diluted) | $(0.50) | $(0.45) | $(0.99) | $(0.82) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$32.1 million** for H1 2025, with a **$3.5 million net decrease** in cash and cash equivalents Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(32,143) | $(23,320) | | Net cash provided by investing activities | $29,355 | $16,285 | | Net cash (used in) provided by financing activities | $(724) | $189 | | **Net decrease in cash and cash equivalents** | **$(3,512)** | **$(6,846)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail accounting policies, strategic partnerships, financing, and subsequent events, confirming sufficient capital for at least one year of operations - The company's flagship products are AVIM therapy for hypertension and Virtue SAB for atherosclerotic artery disease, developed through partnerships with Medtronic and Terumo, respectively[22](index=22&type=chunk) - Management has concluded that based on cash, cash equivalents, marketable securities as of June 30, 2025, and subsequent proceeds, there is sufficient capital to fund operations for at least one year from the issuance date of the financial statements[30](index=30&type=chunk) - The company is in a mediation procedure with Terumo to potentially resolve disagreements regarding the Virtue SAB commercialization agreement, expected to be completed by the end of Q3 2025[77](index=77&type=chunk) - Under the Medtronic agreement for AVIM therapy, the company reimburses Medtronic for certain R&D expenses, which increased significantly to approximately **$7.4 million** for H1 2025 from **$3.1 million** in H1 2024[93](index=93&type=chunk) - Subsequent to the quarter end, the company executed several major financing and strategic transactions in July and August 2025, including a revenue sharing agreement with Ligand, a loan agreement with Medtronic, a public offering, and amendments to its debt facility with Hercules[150](index=150&type=chunk)[158](index=158&type=chunk)[170](index=170&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=55&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The **29% increase in H1 2025 net loss** is due to a **35% rise in R&D expenses**, with **$76.2 million** in post-quarter financing extending the cash runway into H2 2027 [Results of Operations](index=68&type=section&id=Results%20of%20Operations) H1 2025 revenue increased **22% to $1.7 million**, but a **35% rise in R&D expenses** led to a **$38.1 million net loss** Comparison of Six Months Ended June 30, 2025 and 2024 (in thousands) | Metric | YTD 2025 | YTD 2024 | Change $ | Change % | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $1,704 | $1,398 | $306 | 22% | | Research and development | $27,335 | $20,238 | $7,097 | 35% | | Selling, general and administrative | $12,527 | $12,364 | $163 | 1% | | **Net loss** | **$(38,118)** | **$(29,443)** | **$(8,675)** | **(29)%** | - The **$7.1 million (35%) increase in R&D expenses** for H1 2025 was primarily due to increased clinical development costs (**$3.0 million**), higher personnel and consulting costs (**$2.2 million**), and increased non-clinical development costs (**$1.1 million**) to advance the BACKBEAT and Virtue SAB studies[220](index=220&type=chunk) Comparison of Three Months Ended June 30, 2025 and 2024 (in thousands) | Metric | Q2 2025 | Q2 2024 | Change $ | Change % | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $836 | $778 | $58 | 7% | | Research and development | $13,853 | $11,126 | $2,727 | 25% | | Selling, general and administrative | $6,264 | $6,467 | $(203) | (3)% | | **Net loss** | **$(19,363)** | **$(15,980)** | **$(3,383)** | **(21)%** | [Liquidity and Capital Resources](index=73&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held **$33.9 million** in liquid assets, with **$76.2 million** received post-quarter and **$35 million** committed for 2026, extending the cash runway into H2 2027 - As of June 30, 2025, the company held **$18.7 million** in cash and cash equivalents and **$15.2 million** in marketable securities[239](index=239&type=chunk) - On August 4, 2025, the company received **$76.2 million** from a combination of a public offering, private placements with Medtronic and Ligand, and a revenue sharing agreement with Ligand[239](index=239&type=chunk) - The company expects to receive an additional **$35.0 million** in committed capital in 2026, consisting of **$20.0 million** from a loan agreement with Medtronic and **$15.0 million** from Ligand[239](index=239&type=chunk) - Based on current plans and recent financing, the company projects its cash runway is sufficient to fund operations into the second half of 2027[241](index=241&type=chunk) [Critical Accounting Policies and Estimates](index=77&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Critical accounting policies involve significant judgment in revenue recognition for the Terumo partnership and stock-based compensation, with estimates impacting financials - Revenue from the Terumo Agreement is recognized using a proportional performance model, relying on management's estimate of total costs to complete the performance obligation, which can affect revenue recognition timing[266](index=266&type=chunk)[268](index=268&type=chunk) - Stock-based compensation expense totaled **$6.2 million** for H1 2025, with **$16.8 million** of unrecognized expense remaining as of June 30, 2025, to be recognized over 2.3 years[282](index=282&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=87&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Quantitative and qualitative disclosures regarding market risk are not applicable for this reporting period - The company has indicated that quantitative and qualitative disclosures about market risk are not applicable[290](index=290&type=chunk) [Controls and Procedures](index=87&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - Based on an evaluation as of June 30, 2025, the CEO and CFO concluded that the company's disclosure controls and procedures were effective[293](index=293&type=chunk) - No material changes to the company's internal control over financial reporting occurred during the fiscal quarter ended June 30, 2025[294](index=294&type=chunk) [PART II. OTHER INFORMATION](index=87&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=87&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings, nor is it aware of any pending or threatened actions - As of the filing date, the company reports no material legal proceedings[297](index=297&type=chunk) [Risk Factors](index=89&type=section&id=Item%201A.%20Risk%20Factors) No material changes to previously disclosed risk factors have occurred since the last annual and quarterly reports - The company states there are no material changes to its previously disclosed risk factors[298](index=298&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=89&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported during the period - None reported for the period[299](index=299&type=chunk) [Other Information](index=89&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the second quarter of 2025 - No directors or officers adopted or terminated a Rule 10b5-1 trading plan during the second quarter of 2025[302](index=302&type=chunk) [Exhibits](index=90&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents, financing agreements, and officer certifications
Smithfield Foods(SFD) - 2025 Q2 - Quarterly Results
2025-08-12 11:59
Smithfield Foods' Strategy Execution and Agile Business Model Drive Strong Second Quarter Results SMITHFIELD, Va., August 12, 2025 -- Smithfield Foods, Inc. (Nasdaq: SFD), an American food company and an industry leader in value-added packaged meats and fresh pork, today reported results for its fiscal 2025 second quarter ended June 29, 2025. Second Quarter Fiscal 2025 Financial Highlights First Six Months Fiscal 2025 Financial Highlights CEO Perspective • Net sales of $7.6 billion, up 10.2% from the first ...
Mereo BioPharma(MREO) - 2025 Q2 - Quarterly Report
2025-08-12 11:55
PART I – FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements.) This section presents unaudited condensed consolidated financial statements, including balance sheets, statements of operations, cash flows, and equity changes, with detailed notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 ($'000) | December 31, 2024 ($'000) | Change ($'000) | Change (%) | | :-------------------------------- | :--------------------- | :------------------------ | :------------- | :--------- | | Cash and cash equivalents | 56,125 | 69,802 | (13,677) | -19.59% | | Total current assets | 61,421 | 74,763 | (13,342) | -17.85% | | Total assets | 62,631 | 76,390 | (13,759) | -18.01% | | Total current liabilities | 7,557 | 13,848 | (6,291) | -45.43% | | Total liabilities | 8,454 | 15,421 | (6,967) | -45.18% | | Total shareholders' equity | 54,177 | 60,969 | (6,792) | -11.14% | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share) | Metric (3 Months Ended June 30) | 2025 ($'000) | 2024 ($'000) | Change ($'000) | Change (%) | | :------------------------------ | :----------- | :----------- | :------------- | :--------- | | Revenue | 500 | — | 500 | N/A | | Cost of revenue | (132) | — | (132) | N/A | | Research and development | (5,373) | (4,946) | (427) | 8.63% | | General and administrative | (5,494) | (7,868) | 2,374 | -30.17% | | Loss from operations | (10,499) | (12,814) | 2,315 | -18.07% | | Net loss | (14,616) | (12,255) | (2,361) | 19.27% | | Loss per share – basic and diluted | (0.02) | (0.02) | 0.00 | 0.00% | | Metric (6 Months Ended June 30) | 2025 ($'000) | 2024 ($'000) | Change ($'000) | Change (%) | | :------------------------------ | :----------- | :----------- | :------------- | :--------- | | Revenue | 500 | — | 500 | N/A | | Cost of revenue | (132) | — | (132) | N/A | | Research and development | (9,303) | (8,939) | (364) | 4.07% | | General and administrative | (12,766) | (13,777) | 1,011 | -7.34% | | Loss from operations | (21,701) | (22,716) | 1,015 | -4.47% | | Net loss | (27,503) | (21,208) | (6,295) | 29.68% | | Loss per share – basic and diluted | (0.03) | (0.03) | 0.00 | 0.00% | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity (Six Months Ended June 30) | 2025 ($'000) | 2024 ($'000) | Change ($'000) | Change (%) | | :-------------------------------------------- | :----------- | :----------- | :------------- | :--------- | | Net loss | (27,503) | (21,208) | (6,295) | 29.68% | | Net cash used in operating activities | (15,980) | (15,895) | (85) | 0.54% | | Net cash used in investing activities | (320) | (699) | 379 | -54.22% | | Net cash provided by financing activities | 288 | 46,781 | (46,493) | -99.38% | | (Decrease)/increase in cash and cash equivalents | (16,012) | 30,187 | (46,199) | -153.05% | | Cash and cash equivalents at June 30 | 56,125 | 87,431 | (31,306) | -35.81% | [Condensed Consolidated Statements of Changes in Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Equity) - As of June 30, 2025, the number of ordinary shares issued increased to **795,001,444** from **775,728,034** at December 31, 2024, primarily due to the non-cash conversion of the Novartis Loan Note (**17,105,450 shares**), the exercise of 2020 Novartis Warrants (**1,449,610 shares**), and the vesting of RSUs (**718,350 shares**)[23](index=23&type=chunk)[58](index=58&type=chunk)[59](index=59&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) [1. Nature of business](index=8&type=section&id=1.%20Nature%20of%20business) - **Mereo BioPharma Group plc** is a U.K.-based biopharmaceutical company focused on developing innovative therapeutics for rare diseases, with primary late-stage clinical product candidates **setrusumab** for **osteogenesis imperfecta (OI)** and **alvelestat** for **severe alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD)**[26](index=26&type=chunk) [2. Basis of presentation and summary of significant accounting policies](index=8&type=section&id=2.%20Basis%20of%20presentation%20and%20summary%20of%20significant%20accounting%20policies) - The unaudited condensed consolidated financial statements are prepared in **U.S. GAAP** and presented in **U.S. dollars**; the company, historically **loss-making** with an **accumulated deficit of $486.6 million** as of June 30, 2025, expects its **cash and cash equivalents of $56.1 million** to fund operations for **at least twelve months**[28](index=28&type=chunk)[32](index=32&type=chunk)[34](index=34&type=chunk) [3. Recent accounting pronouncements](index=9&type=section&id=3.%20Recent%20accounting%20pronouncements) - There have been **no recent accounting pronouncements or changes** in accounting guidance of significance to the Company beyond those previously disclosed in the **2024 Annual Report**[36](index=36&type=chunk) [4. Fair value measurement](index=9&type=section&id=4.%20Fair%20value%20measurement) Financial Assets and Liabilities Measured at Fair Value (in thousands) | Item | As of June 30, 2025 ($'000) | As of December 31, 2024 ($'000) | | :---------------------------------- | :-------------------------- | :----------------------------- | | Cash equivalents (money market funds) | 13,457 | N/A | | Warrant liabilities | 545 | 821 | [5. Prepaid expenses and other current assets](index=10&type=section&id=5.%20Prepaid%20expenses%20and%20other%20current%20assets) Prepaid Expenses and Other Current Assets (in thousands) | Item | June 30, 2025 ($'000) | December 31, 2024 ($'000) | | :--------------------------------- | :-------------------- | :------------------------ | | VAT receivable | 496 | 464 | | Prepaid research and development | 139 | 201 | | Milestone payment receivable | 500 | — | | Security deposits | 402 | 378 | | Prepaid insurance premiums | 185 | 1,003 | | Prepaid general and administrative | 823 | 129 | | **Total** | **2,545** | **2,175** | [6. Property and equipment, net](index=10&type=section&id=6.%20Property%20and%20equipment,%20net) Property and Equipment, Net (in thousands) | Item | June 30, 2025 ($'000) | December 31, 2024 ($'000) | | :--------------------------------- | :-------------------- | :------------------------ | | Property and equipment, at cost | 1,328 | 1,206 | | Less: accumulated depreciation | (1,110) | (949) | | **Property and equipment, net** | **218** | **257** | - Depreciation expense was **less than $0.1 million** for the three months ended June 30, 2025, and **$0.1 million** for the six months ended June 30, 2025[42](index=42&type=chunk) [7. Leases](index=10&type=section&id=7.%20Leases) - The Company leases office space in London, with lease terms for both the fourth and fifth floors ending in **June 2026**; total lease expense was **$0.2 million** for the three months and **$0.3 million** for the six months ended June 30, 2025[43](index=43&type=chunk)[44](index=44&type=chunk) Operating Lease Liabilities Maturity Analysis (in thousands) | Year Ending December 31 | As of June 30, 2025 ($'000) | | :---------------------- | :-------------------------- | | 2025 | 418 | | 2026 | 209 | | Total undiscounted payments | 627 | | Less: Present value discount | (26) | | **Lease liability** | **601** | [8. Other current liabilities](index=11&type=section&id=8.%20Other%20current%20liabilities) Other Current Liabilities (in thousands) | Item | June 30, 2025 ($'000) | December 31, 2024 ($'000) | | :---------------------------- | :-------------------- | :------------------------ | | Social security and other taxes | 296 | 503 | | Deferred consideration liability | 276 | 296 | | Equity issuance costs payable | 94 | 235 | | Other current liabilities | 111 | 61 | | **Total** | **777** | **1,095** | [9. Accrued expenses](index=11&type=section&id=9.%20Accrued%20expenses) Accrued Expenses (in thousands) | Item | June 30, 2025 ($'000) | December 31, 2024 ($'000) | | :------------------------------ | :-------------------- | :------------------------ | | Accrued research and development | 2,512 | 948 | | Accrued legal and professional fees | 608 | 727 | | Accrued bonus | 1,257 | 2,001 | | Accrued cost of revenue | 132 | — | | Accrued local taxes | 189 | 267 | | Other accrued expenses | 343 | 128 | | **Total** | **5,041** | **4,071** | [10. Convertible loan notes and equity classified warrants](index=12&type=section&id=10.%20Convertible%20loan%20notes%20and%20equity%20classified%20warrants) - On **February 7, 2025**, the **Novartis Loan Note**, with a net carrying amount of **$5.5 million** as of December 31, 2024, was converted into **17,105,450 ordinary shares**; additionally, **1,449,610 ordinary shares** were issued upon the exercise of the **2020 Novartis Warrants**, generating **$0.5 million**[52](index=52&type=chunk)[53](index=53&type=chunk)[55](index=55&type=chunk) - Interest expense related to the Novartis Loan Note **decreased significantly** to **$0.2 million** for the three and six months ended June 30, 2025, from **$0.3 million** and **$0.6 million** respectively in 2024, due to its conversion[54](index=54&type=chunk) [11. Warrant liability](index=12&type=section&id=11.%20Warrant%20liability) Warrant Liabilities (in thousands) | Metric | 2025 ($'000) | 2024 ($'000) | | :--------------- | :----------- | :----------- | | At January 1 | 821 | 412 | | At June 30 | 545 | 925 | - As of **June 30, 2025**, former lenders hold warrants to purchase **1,243,908 ordinary shares** at **£2.95 per share** (exercisable until **August 2027**) and **1,243,908 ordinary shares** at **$0.4144 per share** (exercisable until **August 2027-October 2028**), with fair value estimated using the **Black-Scholes option pricing model**[56](index=56&type=chunk)[57](index=57&type=chunk) [12. Shareholders' Equity](index=13&type=section&id=12.%20Shareholders'%20Equity) Ordinary Shares Activity (Number of Shares) | Event | Number of ordinary shares | | :---------------------------------- | :------------------------ | | At January 1, 2025 | 775,728,034 | | Vesting of RSUs | 718,350 | | Conversion of convertible loan notes | 17,105,450 | | Exercise of warrants | 1,449,610 | | **At June 30, 2025** | **795,001,444** | [13. Revenue and cost of revenue](index=13&type=section&id=13.%20Revenue%20and%20cost%20of%20revenue) - The Company recognized **$0.5 million** in revenue for the three and six months ended **June 30, 2025**, from a milestone payment under the **ReproNovo Licensing Agreement** for **leflutrozole** following a **Phase 2 trial** initiation, resulting in a corresponding **cost of revenue of $0.1 million** payable to **Novartis**[61](index=61&type=chunk)[62](index=62&type=chunk)[63](index=63&type=chunk) [14. Share based compensation](index=14&type=section&id=14.%20Share%20based%20compensation) Share-Based Compensation Expense (in thousands) | Plan (3 Months Ended June 30) | 2025 ($'000) | 2024 ($'000) | | :---------------------------- | :----------- | :----------- | | 2019 EIP | 1,617 | 1,568 | | 2019 NED EIP | 448 | 520 | | **Total** | **2,065** | **2,088** | | Plan (6 Months Ended June 30) | 2025 ($'000) | 2024 ($'000) | | :---------------------------- | :----------- | :----------- | | 2019 EIP | 3,214 | 3,027 | | 2019 NED EIP | 1,129 | 1,111 | | **Total** | **4,343** | **4,138** | - As of **June 30, 2025**, the total unrecognized compensation cost related to outstanding share awards was **$6.9 million**, expected to be recognized over a weighted-average period of **1.7 years**[66](index=66&type=chunk) [15. Loss per share](index=17&type=section&id=15.%20Loss%20per%20share) Loss Per Share (in thousands, except per share amounts) | Metric (3 Months Ended June 30) | 2025 ($'000) | 2024 ($'000) | | :------------------------------ | :----------- | :----------- | | Net loss | (14,616) | (12,255) | | Net loss per share - basic and diluted | (0.02) | (0.02) | | Weighted-average shares outstanding | 799,435,329 | 711,770,804 | | Metric (6 Months Ended June 30) | 2025 ($'000) | 2024 ($'000) | | :------------------------------ | :----------- | :----------- | | Net loss | (27,503) | (21,208) | | Net loss per share - basic and diluted | (0.03) | (0.03) | | Weighted-average shares outstanding | 794,022,295 | 706,407,371 | - **Potentially dilutive securities**, including share-based compensation awards, convertible loan notes (in 2024), and warrants, were excluded from diluted net loss per share calculations as their effect would be **anti-dilutive**[81](index=81&type=chunk)[82](index=82&type=chunk) [16. Commitments and contingencies](index=17&type=section&id=16.%20Commitments%20and%20contingencies) - The Company has agreed to future payments to **Novartis** based on **tiered annual worldwide net sales** of acquired assets and a percentage of proceeds from certain transactions; under the **Amended AstraZeneca Agreements**, potential future payments of **up to $114.3 million** in **cash and variable ADSs** are tied to milestones for **alvelestat**[84](index=84&type=chunk)[85](index=85&type=chunk)[88](index=88&type=chunk)[90](index=90&type=chunk) - Manufacturing commitments with CMOs totaled **$0.7 million** as of **June 30, 2025**, an **increase from $0.5 million** at **December 31, 2024**; the Company also has a manufacturing and supply agreement with **Ultragenyx** for **setrusumab**[92](index=92&type=chunk)[94](index=94&type=chunk) - As of **June 30, 2025**, the Company was **not a party to any material litigation** and had **no material contingency reserves**[95](index=95&type=chunk) [17. Related party disclosures](index=19&type=section&id=17.%20Related%20party%20disclosures) - There were **no reportable related party transactions** during the three and six months ended June 30, 2025 and 2024[96](index=96&type=chunk) [18. Segment information](index=19&type=section&id=18.%20Segment%20information) - The Company operates as a **single segment** focused on developing **rare disease therapies**, with performance assessed based on **consolidated net loss before income tax**[97](index=97&type=chunk)[98](index=98&type=chunk) R&D Expenses by Product Development Program (in thousands) | Program (3 Months Ended June 30) | 2025 ($'000) | 2024 ($'000) | Change ($'000) | Change (%) | | :------------------------------- | :----------- | :----------- | :------------- | :--------- | | Setrusumab (BPS-804/UX143) | (3,687) | (1,448) | (2,239) | 154.63% | | Alvelestat (MPH-966) | (1,396) | (2,902) | 1,506 | -51.90% | | Etigilimab (MPH-313) | (224) | (468) | 244 | -52.14% | | Other | (66) | (128) | 62 | -48.44% | | **Total R&D expenses** | **(5,373)** | **(4,946)** | **(427)** | **8.63%** | | Program (6 Months Ended June 30) | 2025 ($'000) | 2024 ($'000) | Change ($'000) | Change (%) | | :------------------------------- | :----------- | :----------- | :------------- | :--------- | | Setrusumab (BPS-804/UX143) | (5,930) | (2,357) | (3,573) | 151.59% | | Alvelestat (MPH-966) | (2,761) | (5,515) | 2,754 | -49.94% | | Etigilimab (MPH-313) | (431) | (818) | 387 | -47.31% | | Other | (181) | (249) | 68 | -27.31% | | **Total R&D expenses** | **(9,303)** | **(8,939)** | **(364)** | **4.07%** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and results of operations for the three and six months ended June 30, 2025, covering business overview, recent developments, performance, liquidity, and critical accounting estimates [Overview](index=20&type=section&id=Overview) - **Mereo BioPharma** is a biopharmaceutical company focused on **rare diseases**, with late-stage clinical product candidates **setrusumab (for OI)** and **alvelestat (for AATD-LD)**, leveraging prior investment and regulatory pathways[102](index=102&type=chunk)[103](index=103&type=chunk)[104](index=104&type=chunk) [Recent Developments](index=20&type=section&id=Recent%20Developments) - On **July 9, 2025**, **Mereo** and **Ultragenyx** announced the **Phase 3 Orbit study** for **setrusumab** in OI patients is progressing towards **final analysis by the end of 2025** with an **acceptable safety profile**, with the **Cosmic study** also proceeding to final analysis concurrently[105](index=105&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) [Comparison of three months ended June 30, 2025 and 2024](index=21&type=section&id=Comparison%20of%20three%20months%20ended%20June%2030,%202025%20and%202024) - **Revenue increased to $0.5 million** in **Q2 2025** from zero in Q2 2024, driven by a **milestone payment from ReproNovo for leflutrozole**, which also led to a new **cost of revenue of $0.1 million**[108](index=108&type=chunk)[109](index=109&type=chunk) - **Total R&D expenses increased by $0.4 million (8.6%) to $5.4 million**, primarily due to a **$2.2 million increase in setrusumab expenses** for manufacturing and real-world evidence activities, partially offset by decreases in alvelestat and etigilimab expenses[111](index=111&type=chunk)[112](index=112&type=chunk)[113](index=113&type=chunk)[114](index=114&type=chunk) - **General and administrative expenses decreased by $2.4 million (30.2%) to $5.5 million**, mainly due to a **$1.9 million reimbursement** for ADR program expenses and lower professional fees, with pre-commercial activities for setrusumab in Europe accounting for **$1.2 million of G&A expenses**[115](index=115&type=chunk)[116](index=116&type=chunk) - **Interest expense decreased by $0.3 million** due to the **conversion of convertible loan notes** in **February 2025**; a **net foreign exchange loss of $5.3 million** was recorded, compared to a **gain of less than $0.1 million** in Q2 2024, primarily due to a weakening U.S. dollar[118](index=118&type=chunk)[120](index=120&type=chunk) [Comparison of six months ended June 30, 2025 and 2024](index=23&type=section&id=Comparison%20of%20six%20months%20ended%20June%2030,%202025%20and%202024) - Revenue for the six months ended June 30, 2025, was **$0.5 million**, a new recognition from a **ReproNovo milestone payment**, with a corresponding **cost of revenue of $0.1 million**[126](index=126&type=chunk)[127](index=127&type=chunk) - **Total R&D expenses increased by $0.4 million (4.1%) to $9.3 million**, driven by a **$3.6 million increase for setrusumab**, partially offset by decreases for alvelestat and etigilimab due to completed manufacturing activities for alvelestat's Phase 3 study[129](index=129&type=chunk)[130](index=130&type=chunk)[131](index=131&type=chunk)[132](index=132&type=chunk) - **General and administrative expenses decreased by $1.0 million (7.3%) to $12.8 million**, primarily due to lower professional fees, with pre-commercial activities for setrusumab in Europe amounting to **$2.3 million**[133](index=133&type=chunk)[134](index=134&type=chunk) - **Interest expense decreased by $0.4 million** due to the **conversion of convertible loan notes**; a **net foreign exchange loss of $8.1 million** was recorded, compared to a **gain of $0.6 million** in the prior year, primarily due to a weakening U.S. dollar[136](index=136&type=chunk)[138](index=138&type=chunk) - The benefit from **R&D tax credit increased by $0.1 million to $0.9 million**, reflecting a higher level of qualifying expenditure[139](index=139&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) - The Company anticipates its current cash resources will **fund operations and capital expenditures into 2027**, though **additional external funding will be required** to complete development and commercialization plans, potentially from non-dilutive sources, equity/debt financing, or collaborations[141](index=141&type=chunk)[155](index=155&type=chunk)[156](index=156&type=chunk) - Historically, operations have been financed through **equity issuances, convertible debt, warrants, and license/collaboration agreements**, raising approximately **$259.0 million in gross proceeds**[142](index=142&type=chunk) Cash Flow Summary (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2025 ($'000) | 2024 ($'000) | Change ($'000) | | :----------------- | :----------- | :----------- | :------------- | | Operating | (15,980) | (15,895) | (85) | | Investing | (320) | (699) | 379 | | Financing | 288 | 46,781 | (46,493) | - **Net cash used in operating activities increased slightly by $0.1 million**, primarily due to the **absence of a $2.0 million D&O insurance claim reimbursement** received in 2024; **Net cash provided by financing activities decreased by $46.5 million** due to the **absence of a significant registered direct offering** in 2025, which provided **$46.2 million in 2024**[148](index=148&type=chunk)[150](index=150&type=chunk) - Future capital requirements depend on factors such as **setrusumab collaboration costs, manufacturing, regulatory approvals, commercialization activities, intellectual property, and potential new acquisitions or partnerships**[155](index=155&type=chunk) [Critical Accounting Estimates](index=28&type=section&id=Critical%20Accounting%20Estimates) - Management believes there are **no estimates and assumptions** in the unaudited condensed consolidated financial statements that rise to the level of **critical accounting estimates**, with **no significant changes** from those described in the **2024 Annual Report**[161](index=161&type=chunk)[162](index=162&type=chunk) [Recent accounting pronouncements](index=28&type=section&id=Recent%20accounting%20pronouncements) - **No recent accounting pronouncements or changes** in accounting guidance of significance to the Company have occurred beyond those previously included in the **2024 Annual Report**[163](index=163&type=chunk) [Safe Harbor](index=28&type=section&id=Safe%20Harbor) - This section refers to the **'Information Regarding Forward-Looking Statements'** at the beginning of the Quarterly Report, highlighting **risks and uncertainties** associated with forward-looking statements[164](index=164&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Mereo BioPharma Group PLC is not required to provide the information typically mandated by this item regarding market risk disclosures - The Company is **exempt** from providing quantitative and qualitative disclosures about market risk as it qualifies as a **'smaller reporting company'**[165](index=165&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, with the participation of the CEO and CFO, evaluated the effectiveness of the company's disclosure controls and procedures as of June 30, 2025, concluding they were effective; no material changes to internal control over financial reporting occurred during the period - Management, including the CEO and CFO, concluded that the Company's disclosure controls and procedures were **effective** as of June 30, 2025[166](index=166&type=chunk)[167](index=167&type=chunk) - **No changes in internal control over financial reporting** occurred during the three months ended June 30, 2025, that materially affected or are reasonably likely to materially affect internal control over financial reporting[168](index=168&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) As of June 30, 2025, Mereo BioPharma Group PLC was not involved in any material legal proceedings - As of June 30, 2025, the Company was **not a party to any material legal proceedings**[170](index=170&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the Company's 2024 Annual Report - **No material changes** have occurred from the risk factors previously disclosed in the Company's **2024 Annual Report**[171](index=171&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period - There were **no unregistered sales of equity securities or use of proceeds** to report[172](index=172&type=chunk) [Item 3. Defaults Upon Senior Securities](index=30&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the Company for the reporting period - This item is **not applicable**[173](index=173&type=chunk) [Item 4. Mine Safety Disclosures](index=30&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the Company for the reporting period - This item is **not applicable**[174](index=174&type=chunk) [Item 5. Other Information](index=30&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the three-month period ended June 30, 2025 - **No directors or officers** adopted, modified, or terminated **Rule 10b5-1 or non-Rule 10b5-1 trading arrangements** during the three-month period ended June 30, 2025[175](index=175&type=chunk) [Item 6. Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including certifications from the Chief Executive Officer and Chief Financial Officer, and Inline XBRL documents - The report includes **certifications from the Chief Executive Officer and Chief Financial Officer** (Exhibits 31.1, 31.2, 32.1, 32.2) and **Inline XBRL documents** (Exhibits 101.INS, 101.SCH, 104)[177](index=177&type=chunk) Signatures [Signatures](index=32&type=section&id=Signatures) The report was duly signed on August 12, 2025, by Denise Scots-Knight, Chief Executive Officer, and Christine Fox, Chief Financial Officer, on behalf of Mereo BioPharma Group PLC - The report was signed on **August 12, 2025**, by **Denise Scots-Knight (Chief Executive Officer)** and **Christine Fox (Chief Financial Officer)**[180](index=180&type=chunk)[182](index=182&type=chunk)
Xtant Medical (XTNT) - 2025 Q2 - Quarterly Results
2025-08-12 11:51
Exhibit 99.1 Xtant Medical Reports Second Quarter 2025 Financial Results Total Revenue of $35.4 Million Increased 18% Year-over-Year Delivers Positive Net Income, Adjusted EBITDA and Operating Cash Flow Raises FY25 Revenue Guidance to $131-$135 Million, Representing Growth of 11%-15% over FY24 BELGRADE, Mont., August 12, 2025 — Xtant Medical Holdings, Inc. (NYSE American: XTNT), a global medical technology company focused on surgical solutions for the treatment of spinal, orthopedic, and woundcare disorders ...
Sypris Solutions(SYPR) - 2025 Q2 - Quarterly Results
2025-08-12 11:50
Exhibit 99 For more information, contact: Rebecca R. Eckert Chief Accounting Officer (502) 329-2000 SYPRIS REPORTS SECOND QUARTER RESULTS ORDERS UP 110% TO $47 MILLION FOR SYPRIS ELECTRONICS STRONG DEMAND FROM ELECTRONIC WARFARE AND COMMUNICATIONS MARKETS LOUISVILLE, KY (August 12, 2025) – Sypris Solutions, Inc. (Nasdaq/GM: SYPR) today reported financial results for its second quarter ended June 29, 2025. HIGHLIGHTS - MORE - ● The Company's second quarter revenue decreased compared to the prior-year quarter ...
Bitfarms .(BITF) - 2025 Q2 - Quarterly Report
2025-08-12 11:47
[Interim Consolidated Statements of Financial Position](index=3&type=section&id=Interim%20Consolidated%20Statements%20of%20Financial%20Position) [Summary of Financial Position](index=3&type=section&id=Interim%20Consolidated%20Statements%20of%20Financial%20Position_Summary) The company's financial position as of June 30, 2025, shows significant increases in total assets, liabilities, and equity, primarily driven by business acquisitions and financing activities **Consolidated Statements of Financial Position (kUSD):** | Category | June 30, 2025 | December 31, 2024 | Change | | :--------------------------------------- | :------------ | :---------------- | :----- | | **Assets** | | | | | Total Current Assets | 278,261 | 213,709 | +64,552 | | Total Non-current Assets | 549,689 | 453,907 | +95,782 | | **Total Assets** | **827,950** | **667,616** | **+160,334** | | **Liabilities** | | | | | Total Current Liabilities | 89,470 | 36,270 | +53,200 | | Total Non-current Liabilities | 75,994 | 23,351 | +52,643 | | **Total Liabilities** | **165,464** | **59,621** | **+105,843** | | **Shareholders' Equity** | **662,486** | **607,995** | **+54,491** | | **Total Liabilities and Equity** | **827,950** | **667,616** | **+160,334** | - Significant increases in Property, Plant and Equipment (PPE) to **$477,086k** (from $348,525k) and Long-term Debt to **$50,999k** (from $1,430k) reflect capital investments and new financing[3](index=3&type=chunk) - Digital assets (excluding restricted) decreased to **$59,029k** from $87,298k, while restricted digital assets increased to **$66,922k** from $32,826k[3](index=3&type=chunk) [Interim Consolidated Statements of Profit or Loss and Comprehensive Profit or Loss](index=5&type=section&id=Interim%20Consolidated%20Statements%20of%20Profit%20or%20Loss%20and%20Comprehensive%20Profit%20or%20Loss) [Summary of Profit or Loss and Comprehensive Profit or Loss](index=5&type=section&id=Interim%20Consolidated%20Statements%20of%20Profit%20or%20Loss%20and%20Comprehensive%20Profit%20or%20Loss_Summary) For the six months ended June 30, 2025, revenues increased substantially, but higher costs, expenses, and impairment losses led to a larger net and comprehensive loss **Consolidated Statements of Profit or Loss (kUSD, except per share amounts):** | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenues | 77,800 | 41,548 | 144,648 | 91,865 | | Cost of revenues | (83,280) | (52,823) | (150,670) | (113,822) | | Gross loss | (5,480) | (11,275) | (6,022) | (21,957) | | Operating loss | (39,626) | (23,578) | (71,985) | (47,286) | | Net loss | (28,844) | (26,599) | (64,719) | (32,579) | | Total comprehensive loss, net of tax | (5,841) | (32,054) | (55,137) | (20,601) | | Loss per share (Basic and diluted) | (0.05) | (0.07) | (0.12) | (0.09) | - Revenues for the six months ended June 30, 2025, increased by **57.4% year-over-year**, reaching **$144,648k**[5](index=5&type=chunk) - Impairment of non-financial assets significantly impacted operating results, with a loss of **$31,850k** for the six months ended June 30, 2025, compared to nil in the prior year[5](index=5&type=chunk) [Interim Consolidated Statements of Changes in Equity](index=6&type=section&id=Interim%20Consolidated%20Statements%20of%20Changes%20in%20Equity) [Summary of Changes in Equity](index=6&type=section&id=Interim%20Consolidated%20Statements%20of%20Changes%20in%20Equity_Summary) Shareholders' equity increased for the six months ended June 30, 2025, primarily due to common share issuances and equity warrants, partially offset by net loss and revaluation surplus transfer **Consolidated Statements of Changes in Equity (kUSD, except number of shares):** | Metric | January 1, 2025 | June 30, 2025 | | :--------------------------------------- | :-------------- | :------------ | | Balance of shares | 479,332,885 | 557,548,857 | | Share capital | 852,286 | 947,329 | | Equity warrants | — | 11,477 | | Contributed surplus | 67,521 | 70,629 | | Accumulated deficit | (334,507) | (383,992) | | Revaluation surplus | 22,695 | 17,043 | | **Total equity** | **607,995** | **662,486** | **Key Changes (Six months ended June 30, 2025):** | Change | Value (kUSD) | | :--------------------------------------- | :----------- | | Net loss | (64,719) | | Change in revaluation surplus - digital assets, net of tax | 9,582 | | Issuance of common shares | 89,864 | | Issuance of equity warrants | 11,477 | | Share-based payment | 8,052 | - Total equity increased by **$54,491k** from January 1, 2025, to June 30, 2025[6](index=6&type=chunk) - Accumulated deficit increased by **$49,485k** due to the net loss and transfer of revaluation surplus[6](index=6&type=chunk) [Interim Consolidated Statements of Cash Flows](index=7&type=section&id=Interim%20Consolidated%20Statements%20of%20Cash%20Flows) [Summary of Cash Flows](index=7&type=section&id=Interim%20Consolidated%20Statements%20of%20Cash%20Flows_Summary) For the six months ended June 30, 2025, operating cash outflows increased, investing activities shifted to inflows, and financing activities continued substantial inflows, resulting in a net cash increase **Consolidated Statements of Cash Flows (kUSD):** | Category | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--------------------------------------- | :----------------------------- | :----------------------------- | | Net change in cash related to operating activities | (93,106) | (55,391) | | Net change in cash related to investing activities | 74,030 | (68,506) | | Net change in cash related to financing activities | 69,936 | 178,362 | | Net increase in cash | 50,860 | 54,465 | | Cash, beginning of the period | 59,542 | 84,038 | | Cash and restricted cash, end of the period | 110,439 | 138,619 | - Cash flows used in operating activities increased by **68.1% year-over-year**, reaching **$(93,106)k**[7](index=7&type=chunk) - Investing activities shifted from a net outflow of **$(68,506)k** in 2024 to a net inflow of **$74,030k** in 2025, largely due to proceeds from the sale of digital assets (**$137,734k**) and disposal of business (**$47,538k**)[7](index=7&type=chunk) [Notes to the Interim Condensed Consolidated Financial Statements (unaudited)](index=7&type=section&id=Notes%20to%20the%20Interim%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) [1. Nature of Operations](index=8&type=section&id=1.%20Nature%20of%20Operations) Bitfarms Ltd. is a cryptocurrency mining company focused on Bitcoin, operating data centers across multiple countries, and recently expanded into refuse power generation via acquisition - Bitfarms' core business involves selling computational power for cryptocurrency mining, primarily on the Bitcoin Blockchain, operating 24 hours a day[9](index=9&type=chunk)[10](index=10&type=chunk) - The company's operations are located in Canada, the United States, Paraguay, and Argentina[9](index=9&type=chunk) - On March 14, 2025, Bitfarms acquired Stronghold Digital Mining, Inc., gaining two refuse power generation facilities and diversifying into internal energy consumption for computational activities or selling energy to the local grid[11](index=11&type=chunk) [2. Liquidity](index=9&type=section&id=2.%20Liquidity) Operating in the volatile Bitcoin Mining industry, Bitfarms faces inherent risks; despite negative operating cash flows, it projects sufficient liquidity for commitments but may require external funding for planned capital investments - The Bitcoin Mining industry is highly volatile, with risks from cryptocurrency price declines, increased mining difficulty, and regulatory changes impacting operations and liquidity[13](index=13&type=chunk) - The company's operating cash flows are negative, as proceeds from BTC sales are classified under investing activities[14](index=14&type=chunk) - Current cash resources and BTC sales are anticipated to be insufficient for planned capital investments in high-performance computing data centers, potentially requiring additional external funding[15](index=15&type=chunk) - On April 1, 2025, the company secured a credit facility for up to **$300,000k** with Macquarie Equipment Capital, Inc., with **$50,000k** drawn as of June 30, 2025[16](index=16&type=chunk) [3. Basis of Presentation and Material Accounting Policy Information](index=10&type=section&id=3.%20Basis%20of%20Presentation%20and%20Material%20Accounting%20Policy%20Information) Interim financial statements are prepared under IFRS Accounting Standards on a historical cost basis with fair value adjustments, adopting new policies for business combinations, warrants, revenue, and RECs, with restated comparative cash flow figures [a. Basis of preparation and measurement](index=10&type=section&id=3a.%20Basis%20of%20preparation%20and%20measurement) Financial statements are prepared under IFRS Accounting Standards on a historical cost basis, with fair value adjustments for certain financial instruments and digital assets - Financial statements are prepared in accordance with International Financial Reporting Standards (IFRS Accounting Standards), specifically IAS 34, Interim Financial Reporting[18](index=18&type=chunk) - The statements are based on the historical cost basis, with exceptions for the revaluation of certain financial instruments and digital assets at fair value, and assets held for sale measured at the lower of carrying amount and fair value less costs to sell[20](index=20&type=chunk) [b. Material new accounting policy information](index=10&type=section&id=3b.%20Material%20new%20accounting%20policy%20information) New accounting policies cover business combinations, warrant liabilities, revenue recognition for energy and hosting, and renewable energy credits - Business combinations are accounted for using the acquisition method, with consideration measured at fair value and acquisition-related costs expensed[22](index=22&type=chunk) - Warrants with a cashless exercise clause are classified as financial liabilities (warrant liabilities) and measured at fair value through profit or loss, while those without are equity instruments (equity warrants)[25](index=25&type=chunk) - Revenue from cryptocurrency hosting and energy sales is recognized over time as performance obligations are met, with energy sales recognized based on invoiced amounts corresponding to delivered megawatt hours[26](index=26&type=chunk)[27](index=27&type=chunk) - Rights to Renewable Energy Credits (RECs) are recognized as intangible assets (IAS 38), with a corresponding contra expense in cost of revenues to offset fuel expenses (IAS 20)[32](index=32&type=chunk) [c. New accounting amendments issued and adopted by the Company](index=13&type=section&id=3c.%20New%20accounting%20amendments%20issued%20and%20adopted%20by%20the%20Company) The company adopted amendments to IAS 21, The Effects of Changes in Foreign Exchange Rates, effective January 1, 2025, with no material impact - Amendments to IAS 21, The Effects of Changes in Foreign Exchange Rates, were adopted for the annual period beginning January 1, 2025, with no impact on the company[35](index=35&type=chunk) [d. New accounting amendments and standards issued to be adopted at a later date](index=14&type=section&id=3d.%20New%20accounting%20amendments%20and%20standards%20issued%20to%20be%20adopted%20at%20a%20later%20date) The company is evaluating the impact of future amendments to IFRS 9, IFRS 7, and the new IFRS 18 on financial statement presentation and disclosure - Amendments to IFRS 9 and IFRS 7 (effective January 1, 2026) clarify financial instrument recognition/derecognition, contingent cash flow characteristics, and disclosure requirements; the company is evaluating the impact[37](index=37&type=chunk)[38](index=38&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk)[41](index=41&type=chunk) - IFRS 18, Presentation and Disclosure in Financial Statements (effective January 1, 2027), will replace IAS 1, introducing new concepts for profit or loss statement structure, management-defined performance measures, and aggregation principles; the company is evaluating the impact[41](index=41&type=chunk)[42](index=42&type=chunk) [e. Restatement of comparative figures](index=15&type=section&id=3e.%20Restatement%20of%20comparative%20figures) Comparative cash flow figures for June 30, 2024, were restated to reclassify proceeds from digital asset sales from operating to investing activities - The company restated comparative figures for the statement of cash flows for the six months ended June 30, 2024, reclassifying proceeds from the sale of digital assets from operating activities to investing activities[43](index=43&type=chunk) **Impact of Restatement on Cash Flows (Six months ended June 30, 2024, kUSD):** | Category | As Reported | Reclassification | As Restated | | :--------------------------------------- | :---------- | :--------------- | :---------- | | Net change in cash related to operating activities | 27,935 | (83,326) | (55,391) | | Net change in cash related to investing activities | (151,832) | 83,326 | (68,506) | [4. Significant Accounting Judgments and Estimates](index=14&type=section&id=4.%20Significant%20Accounting%20Judgments%20and%20Estimates) Management makes significant judgments and estimates for business combinations' fair value allocation and assessing significant influence in associates, which may differ from actual results - Significant judgments and estimates are required for business combinations, specifically in determining the fair value allocation of purchase consideration, which relies on forecasts of revenues, operating costs, capital expenditures, future digital currency prices, and income tax rates[47](index=47&type=chunk) - Determining the existence of significant influence in investments in associates requires judgment, even with less than 20% voting rights, based on factors like board representation, participation in policy-making, and material transactions[48](index=48&type=chunk) [5. Business Combination](index=15&type=section&id=5.%20Business%20Combination) On March 14, 2025, Bitfarms acquired Stronghold Digital Mining, Inc. for $144.7 million in a stock-for-stock merger, diversifying operations and expanding its U.S. presence through vertical integration - Bitfarms acquired **100%** of Stronghold Digital Mining, Inc. on March 14, 2025, in a stock-for-stock merger, issuing **59,866,609 common shares** and **12,893,650 warrants**[49](index=49&type=chunk) - The acquisition, valued at **$144,695k**, diversifies Bitfarms' operations and expands its U.S. presence through vertical integration of power generation and energy arbitrage capabilities[51](index=51&type=chunk)[53](index=53&type=chunk) **Stronghold's Contribution to Bitfarms (kUSD):** | Metric | Proforma (Jan 1 - Jun 30, 2025) | Actual Contribution (Mar 15 - Jun 30, 2025) | | :--------------------------------------- | :------------------------------ | :------------------------------------------ | | Revenue | 154,805 | 27,474 | | Net loss | (80,838) | (2,213) | - Total acquisition-related costs amounted to **$7,081k**, expensed as general and administrative expenses[55](index=55&type=chunk) [6. Sale of the Yguazu Mining Site](index=19&type=section&id=6.%20Sale%20of%20the%20Yguazu%20Mining%20Site) On March 17, 2025, Bitfarms sold its Yguazu, Paraguay mining site to HIVE Digital Technologies Ltd. for $63,260k, realizing a gain of $5,225k - Bitfarms sold its **100%** ownership stake in the Yguazu, Paraguay Bitcoin data center to HIVE Digital Technologies Ltd. on March 17, 2025[59](index=59&type=chunk) **Yguazu Mining Site Sale Details (kUSD):** | Metric | Value | | :--------------------------------------- | :---- | | Total consideration | 63,260 | | Total net assets transferred | 58,035 | | **Gain on disposal of subsidiary** | **5,225** | | Remaining net receivable (June 30, 2025) | 15,087 | [7. Rights to energy credits](index=19&type=section&id=7.%20Rights%20to%20energy%20credits) Rights to energy credits, specifically RECs, increased to $5,572k as of June 30, 2025, driven by the Stronghold acquisition and earned RECs, partially offset by disposals **Movement in Rights to Energy Credits (kUSD):** | Metric | Six-month period ended June 30, 2025 | | :--------------------------------------- | :----------------------------------- | | Balance as of January 1, | — | | Addition related to business combination | 3,102 | | Additions during the period: rights to renewable energy credits | 6,540 | | Less: disposal of renewable energy credits to third parties | (4,070) | | **Balance as of period end** | **5,572** | [8. Digital Assets](index=19&type=section&id=8.%20Digital%20Assets) As of June 30, 2025, the company held 1,176 BTC valued at $125,951k, with 625 BTC restricted, earning 1,411 BTC and selling 1,480 BTC for cash, realizing a gain on disposition but an unrealized loss on revaluation **Digital Assets Balance (June 30, 2025, kUSD):** | Category | Quantity (BTC) | Value | | :--------------------------------------- | :------------- | :---- | | Balance of digital assets including restricted | 1,176 | 125,951 | | Less restricted digital assets | (625) | (66,922) | | **Balance of digital assets excluding restricted** | **551** | **59,029** | **Key BTC Transactions (Six months ended June 30, 2025, kUSD):** | Transaction | Quantity (BTC) | Value | | :--------------------------------------- | :------------- | :---- | | BTC earned | 1,411 | 134,405 | | BTC exchanged for cash | (1,480) | (137,734) | | Realized gain on disposition of digital assets | — | 20,753 | | Change in unrealized loss on revaluation of digital assets | — | (7,714) | - Restricted digital assets include **198 BTC** pledged as deposits for Miners and **427 BTC** held by a financial institution for BTC selling contracts[64](index=64&type=chunk) - A redemption obligation of **$18,396k** was recorded as of June 30, 2025, for BTC Pledged for Miners that have been shipped[65](index=65&type=chunk) [9. Inventories](index=22&type=section&id=9.%20Inventories) Inventories significantly increased to $7,112k as of June 30, 2025, primarily due to the addition of waste, limestone, and fuel oil from the Stronghold business combination **Inventories (kUSD):** | Category | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :------------ | :---------------- | | Waste, limestone and fuel oil | 4,420 | — | | Electronic and networking components | 2,692 | 1,180 | | **Total Inventories** | **7,112** | **1,180** | - Additions from the Stronghold business combination contributed **$3,269k** to inventories[67](index=67&type=chunk) [10. Derivative Assets and Liabilities](index=22&type=section&id=10.%20Derivative%20Assets%20and%20Liabilities) The company uses BTC option and selling contracts and embedded BTC Redemption Options to manage price volatility, reporting total derivative assets of $15,705k and liabilities of $13,082k as of June 30, 2025 - BTC option contracts are purchased to reduce the risk of BTC price volatility and stabilize cash flows from future digital asset sales[68](index=68&type=chunk) - BTC Redemption Options, embedded derivatives in Miner purchase orders, allow the company to redeem pledged BTC at the original pledged price[69](index=69&type=chunk) **Derivative Assets and Liabilities (kUSD):** | Category | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :------------ | :---------------- | | Total derivative assets | 15,705 | 3,418 | | Total derivative liabilities | (13,082) | (128) | **Gain (Loss) on Derivatives (Six months ended June 30, 2025, kUSD):** | Category | Value | | :--------------------------------------- | :---- | | Gain (loss) on BTC options and selling contracts | 453 | | Gain (loss) on BTC Redemption Option | (383) | | Loss on warrants of private company | (44) | | **Total gain (loss)** | **26** | [11. Assets Held for Sale](index=25&type=section&id=11.%20Assets%20Held%20for%20Sale) Assets held for sale, mainly Miners and mining electrical components, decreased to $5,185k as of June 30, 2025, with an impairment loss of $1,320k recorded on Miners **Assets Held for Sale (kUSD):** | Category | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :------------ | :---------------- | | Miners | 4,519 | 4,806 | | Mining electrical components | 666 | 1,117 | | **Total Assets Held for Sale** | **5,185** | **5,923** | - An impairment loss of **$1,320k** was recorded on Miners held for sale during the six months ended June 30, 2025[77](index=77&type=chunk)[78](index=78&type=chunk) [12. Impairment](index=25&type=section&id=12.%20Impairment) Bitfarms recognized significant impairment losses totaling $31,850k for the six months ended June 30, 2025, primarily on its Argentina CGU due to market and operational factors **Impairment Loss (kUSD):** | Category | Three months ended June 30, 2025 | Six months ended June 30, 2025 | | :--------------------------------------- | :------------------------------- | :----------------------------- | | Argentina CGU | 14,620 | 30,530 | | Miners held for sale | — | 1,320 | | **Total Impairment Loss** | **14,620** | **31,850** | - Impairment on the Argentina CGU in Q1 2025 was due to a decline in market capitalization, BTC price, and increased gas prices, totaling **$15,910k**[79](index=79&type=chunk) - A further impairment of **$14,620k** was recorded on the Argentina CGU in Q2 2025 following the halting of electricity supply at the Rio Cuarto facility, leading to a decision to discontinue operations there by November 11, 2025[82](index=82&type=chunk)[83](index=83&type=chunk)[160](index=160&type=chunk) [13. Property, Plant and Equipment](index=28&type=section&id=13.%20Property%2C%20Plant%20and%20Equipment) The net book value of PPE significantly increased to $477,086k as of June 30, 2025, driven by substantial additions from the Stronghold acquisition, partially offset by dispositions and impairment losses **Property, Plant and Equipment (kUSD):** | Metric | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :------------ | :---------------- | | Cost | 709,501 | 521,448 | | Accumulated Depreciation | (232,415) | (172,923) | | **Net book value** | **477,086** | **348,525** | - Additions to PPE for the six months ended June 30, 2025, totaled **$110,149k**, with an additional **$156,687k** from the Stronghold business combination[84](index=84&type=chunk) - Dispositions of PPE amounted to **$(46,177)k**, including **$34,006k** from the sale of the Yguazu Mining Site[84](index=84&type=chunk)[86](index=86&type=chunk) - Impairment losses on PPE totaled **$28,766k** for the six months ended June 30, 2025[84](index=84&type=chunk) [14. Long-term Deposits and Equipment Prepayments](index=29&type=section&id=14.%20Long-term%20Deposits%20and%20Equipment%20Prepayments) Long-term deposits and equipment prepayments decreased significantly to $15,139k as of June 30, 2025, due to the realization of prepayments for received Miners and the sale of deposits with the Yguazu Mining Site **Long-term Deposits and Equipment Prepayments (kUSD):** | Category | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :------------ | :---------------- | | Security deposits for energy, insurance and rent | 10,878 | 4,513 | | Equipment and construction prepayments | 1,627 | 51,854 | | Deferred transaction fees - undrawn tranche of the credit facility | 2,634 | — | | **Total** | **15,139** | **56,367** | - The sale of the Yguazu Mining Site included **$18,321k** of long-term deposits and equipment prepayments[87](index=87&type=chunk) - All Miners from the March 2024 Purchase Order and March 2025 Swap Order were received by June 30, 2025, reducing equipment prepayment amounts to nil[89](index=89&type=chunk)[90](index=90&type=chunk) [15. Refundable Deposits](index=30&type=section&id=15.%20Refundable%20Deposits) Refundable deposits decreased to $5,430k as of June 30, 2025, mainly due to the settlement of Refundable Hosting Deposits post-Stronghold acquisition and derecognition of security deposits from the Yguazu Mining Site disposal **Refundable Deposits (kUSD):** | Category | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :------------ | :---------------- | | Security deposits for energy | 5,080 | 7,740 | | Refundable Hosting Deposits | — | 14,216 | | Other | 350 | — | | **Total** | **5,430** | **21,956** | - Refundable Hosting Deposits were terminated and settled following the acquisition of Stronghold on March 14, 2025, resulting in a gain on settlement of **$945k**[93](index=93&type=chunk)[124](index=124&type=chunk) - Security deposits for energy decreased due to the disposal of the Yguazu Mining site[92](index=92&type=chunk)[123](index=123&type=chunk) [16. Investment in Associate](index=31&type=section&id=16.%20Investment%20in%20Associate) In May 2025, Bitfarms acquired a minority interest in a privately held Canadian company, accounted for using the equity method, resulting in a recognized share of net loss of $3k - In May 2025, the company acquired a minority interest in a privately held Canadian company (PHCC), consisting of preferred shares (**$875k**) and warrants to purchase preferred shares (**$375k**)[94](index=94&type=chunk) - The investment provides significant influence and is accounted for using the equity method[94](index=94&type=chunk) - The company's share of the PHCC's net loss for the three and six months ended June 30, 2025, was **$3k**, included in Net financial income (expenses)[95](index=95&type=chunk) [17. Trade Payables and Accrued Liabilities](index=31&type=section&id=17.%20Trade%20Payables%20and%20Accrued%20Liabilities) Trade payables and accrued liabilities significantly increased to $48,853k as of June 30, 2025, driven by the Stronghold business combination and increases in government remittances and BTC option payables **Trade Payables and Accrued Liabilities (kUSD):** | Category | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :------------ | :---------------- | | Trade accounts payable and accrued liabilities | 35,709 | 21,915 | | Government remittances | 10,757 | 3,736 | | BTC option and selling contracts payable | 2,387 | 243 | | **Total** | **48,853** | **25,894** | - Additions from the Stronghold business combination amounted to **$22,304k** for trade accounts payable and accrued liabilities[96](index=96&type=chunk) [18. Warrant Liabilities](index=31&type=section&id=18.%20Warrant%20Liabilities) Warrant liabilities decreased to $5,151k as of June 30, 2025, including 2023 private placement warrants and new 2025 warrants from the Macquarie credit facility, classified as financial liabilities due to a cashless exercise clause **Warrant Liabilities (kUSD):** | Category | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :------------ | :---------------- | | 2023 Private Placement | 2,228 | 8,013 | | 2025 Warrants | 2,923 | — | | **Total** | **5,151** | **8,013** | - In April 2025, **5,330,946 warrants** (2025 Warrants) were granted to Macquarie in connection with the credit facility[98](index=98&type=chunk) - Warrants are classified as financial liabilities due to a contingent cashless exercise clause and are measured at fair value through profit or loss[99](index=99&type=chunk) - The weighted average contractual life of the warrants as of June 30, 2025, was **2.5 years**[100](index=100&type=chunk) [19. Long-term Debt](index=33&type=section&id=19.%20Long-term%20Debt) Long-term debt, net, significantly increased to $51,580k as of June 30, 2025, primarily due to the initial $50,000k tranche from a new $300,000k credit facility with Macquarie and Stronghold additions **Long-term Debt (kUSD):** | Category | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :------------ | :---------------- | | Building financing | 1,690 | 1,576 | | Equipment financing | 1,434 | — | | Credit Facility | 51,486 | — | | Unamortized transaction costs and warrants | (3,030) | — | | **Total long-term debt, net** | **51,580** | **1,576** | | Less current portion | (581) | (146) | | **Non-current portion** | **50,999** | **1,430** | - A credit facility for up to **$300,000k** was signed with Macquarie in April 2025, with an initial **$50,000k** tranche drawn at **8% interest per annum** (effective rate 16.8%)[104](index=104&type=chunk)[105](index=105&type=chunk) - A second tranche of **$250,000k** will be available in October 2025 upon achieving specific development milestones[106](index=106&type=chunk) - The credit facility includes various financial and non-financial covenants, requiring a restricted cash balance of **$25,000k**, and the company was in compliance as of July 31, 2025[109](index=109&type=chunk)[110](index=110&type=chunk) [20. Income Taxes](index=35&type=section&id=20.%20Income%20Taxes) For the six months ended June 30, 2025, the company recognized a total income tax recovery of $3,013k, primarily from deferred tax recovery, a decrease from the prior year **Income Tax (Expense) Recovery (kUSD):** | Category | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Current tax (expense) recovery | 319 | 262 | (444) | 262 | | Deferred tax recovery (expense) | 8,320 | (1,966) | 3,457 | 4,319 | | **Total tax (expense) recovery** | **8,639** | **(1,704)** | **3,013** | **4,581** | - The total income tax recovery for the six months ended June 30, 2025, was **$3,013k**, a decrease from **$4,581k** in the prior year[111](index=111&type=chunk) [21. Share Capital](index=35&type=section&id=21.%20Share%20Capital) Common shares outstanding significantly increased to 557.5 million as of June 30, 2025, driven by the Stronghold acquisition and ATM equity offering, with additional equity warrants issued **Common Shares Outstanding:** | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :----------------------------- | :----------------------------- | | Outstanding, January 1, | 479,332,885 | 334,153,330 | | Issuance through at-the market equity offering program | 14,444,643 | 84,196,144 | | Issuance through business combination | 59,866,609 | — | | Exercise of stock options | 13,900 | 2,289,148 | | Settlement of share awards | 1,543,320 | — | | Settlement of restricted share units | 2,347,500 | 125,000 | | **Outstanding, June 30,** | **557,548,857** | **425,874,733** | - The ATM Program resulted in the issuance of **14,444,643 common shares** for gross proceeds of **$24,386k** during the six months ended June 30, 2025[113](index=113&type=chunk) - **12,893,650 equity warrants**, valued at **$11,477k**, were issued on March 14, 2025, as part of the Stronghold acquisition[114](index=114&type=chunk) [22. Financial Instruments](index=37&type=section&id=22.%20Financial%20Instruments) Financial assets and liabilities are classified by measurement basis, with derivatives and warrant liabilities measured at fair value through profit or loss, categorized as Level 2 or 3 in the fair value hierarchy **Financial Instruments Carrying and Fair Values (June 30, 2025, kUSD):** | Category | Value | | :--------------------------------------- | :---- | | Financial assets at amortized cost | 136,618 | | Financial assets at fair value through profit and loss | 15,705 | | **Total financial assets** | **152,323** | | Financial liabilities at amortized cost | (108,072) | | Financial liabilities at fair value through profit and loss | (18,233) | | **Total financial liabilities** | **(126,305)** | | **Net carrying amount and fair value** | **26,018** | - Warrant liabilities and derivatives (BTC option/selling contracts and BTC Redemption Options) are measured at fair value through profit or loss, categorized as Level 2 or 3 in the fair value hierarchy[117](index=117&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk) - Refundable Hosting Deposits were settled following the Stronghold acquisition on March 14, 2025, and security deposits for energy related to the Yguazu Mining site were derecognized[122](index=122&type=chunk)[123](index=123&type=chunk) [23. Net Loss Per Share](index=40&type=section&id=23.%20Net%20Loss%20Per%20Share) Potentially dilutive securities were excluded from diluted loss per share calculations for the three and six months ended June 30, 2025 and 2024, as their effect was anti-dilutive **Loss Per Share:** | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Basic and diluted loss per share | (0.05) | (0.07) | (0.12) | (0.09) | | Weighted average number of common shares outstanding (Basic and diluted) | 555,843,347 | 401,238,798 | 528,157,206 | 369,991,664 | - Potentially dilutive securities were not included in the diluted loss per share calculation because their effect was anti-dilutive[125](index=125&type=chunk) [24. Share-based Payments](index=40&type=section&id=24.%20Share-based%20Payments) Share-based payment expense increased to $8,052k for the six months ended June 30, 2025, including grants of stock options and RSUs, with a significant portion for Stronghold employees and management **Share-based Payment Expense (kUSD):** | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Equity-settled share-based payment plans | 3,615 | 1,675 | 8,052 | 4,769 | - During the six months ended June 30, 2025, **2,536,227 stock options** were granted, including **302 options** to Stronghold employees[127](index=127&type=chunk) - **2,783,425 RSUs** were granted, with **1,890,000** to Stronghold employees and executive management as part of the business combination[130](index=130&type=chunk) - **1,543,320 share awards** were granted to a former Stronghold executive, which fully vested in April 2025[132](index=132&type=chunk) [25. Additional Details to the Statement of Profit or Loss and Comprehensive Profit or Loss](index=42&type=section&id=25.%20Additional%20Details%20to%20the%20Statement%20of%20Profit%20or%20Loss%20and%20Comprehensive%20Profit%20or%20Loss) Revenues significantly increased for the six months ended June 30, 2025, driven by mining and energy sales, but were offset by higher energy, infrastructure, and general and administrative costs **Revenues (kUSD):** | Category | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--------------------------------------- | :----------------------------- | :----------------------------- | | Cryptocurrency Mining | 136,155 | 89,806 | | Cryptocurrency Hosting | 3,124 | — | | Electrical services | 2,100 | 2,059 | | Energy sales | 3,269 | — | | **Total Revenues** | **144,648** | **91,865** | **Cost of Revenues (kUSD):** | Category | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--------------------------------------- | :----------------------------- | :----------------------------- | | Energy (net of RECs) | (55,516) | (38,808) | | Depreciation and amortization | (66,701) | (96,314) | | Hosting expenses | (7,735) | — | | Infrastructure expenses | (19,011) | (2,896) | | **Total Cost of Revenues** | **(150,670)** | **(113,822)** | **General and Administrative Expenses (kUSD):** | Category | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--------------------------------------- | :----------------------------- | :----------------------------- | | Salaries and wages | (14,277) | (10,079) | | Share-based payments | (8,052) | (4,769) | | Professional services | (9,978) | (7,353) | | **Total G&A Expenses** | **(41,596)** | **(25,598)** | **Net Financial Income (Expenses) (kUSD):** | Category | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--------------------------------------- | :----------------------------- | :----------------------------- | | Gain (loss) on revaluation of warrants | 5,763 | 7,585 | | Gain (loss) on derivative assets and liabilities | 26 | 355 | | Gain on settlement of Refundable Hosting Deposits | 945 | — | | Interest on long-term debt and lease liabilities | (2,795) | (727) | | **Total Net Financial Income (Expenses)** | **4,253** | **10,126** | [26. Geographical Information](index=44&type=section&id=26.%20Geographical%20Information) Bitfarms operates as a single cryptocurrency Mining segment, with significant revenue growth in North America and increased non-current assets in the U.S. for the six months ended June 30, 2025 - The company is organized into one operating segment: cryptocurrency Mining[139](index=139&type=chunk) **Revenues by Country (kUSD):** | Country | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--------------------------------------- | :----------------------------- | :----------------------------- | | Canada | 58,707 | 60,267 | | United States | 51,098 | 8,183 | | Paraguay | 24,231 | 3,860 | | Argentina | 10,612 | 19,555 | | **Global total** | **144,648** | **91,865** | **Property, Plant and Equipment and other non-current assets by Country (June 30, 2025, kUSD):** | Country | PPE | Other | Total non-current assets | | :--------------------------------------- | :---- | :---- | :----------------------- | | Canada | 88,906 | 18,269 | 107,175 | | United States | 299,430 | 20,052 | 319,482 | | Paraguay | 67,834 | 1,656 | 69,490 | | Argentina | 20,916 | 2,196 | 23,112 | | **Total** | **477,086** | **42,173** | **519,259** | [27. Additional Details to the Statements of Cash Flows](index=45&type=section&id=27.%20Additional%20Details%20to%20the%20Statements%20of%20Cash%20Flows) Changes in working capital resulted in a cash inflow of $13,933k for the six months ended June 30, 2025, with notable non-cash transactions including share and warrant issuances for the Stronghold acquisition **Changes in Working Capital Components (Six months ended June 30, kUSD):** | Component | 2025 | 2024 | | :--------------------------------------- | :--- | :--- | | Increase in trade receivables, net | (374) | (21) | | Decrease (increase) in other current assets | 7,375 | (6,723) | | Increase in inventories | (2,663) | (370) | | Decrease (increase) in deposits | 8,569 | (1,822) | | Increase (decrease) in trade payables and accrued liabilities | 1,576 | (2,588) | | Decrease in taxes payable | (254) | (509) | | Decrease in other non-current liabilities | (296) | — | | **Total** | **13,933** | **(12,033)** | - Significant non-cash transactions for the six months ended June 30, 2025, included the issuance of **$78,161k** in common shares, warrants, and RSUs for the Stronghold acquisition[142](index=142&type=chunk) - Equipment prepayments of **$41,045k** were realized as additions to property, plant and equipment[142](index=142&type=chunk) - Depreciation and Amortization totaled **$66,701k** for the six months ended June 30, 2025[142](index=142&type=chunk) [28. Contingent Liability and Lawsuits](index=45&type=section&id=28.%20Contingent%20Liability%20and%20Lawsuits) Bitfarms faces a potential $9,424k U.S. importation duty on Miners, has accrued $3,101k for legal settlements, and is unable to estimate the loss from a new class action lawsuit filed in May 2025 - A potential U.S. importation duty of **$9,424k** on Miners is not considered probable to result in a future cash outflow by management[143](index=143&type=chunk)[144](index=144&type=chunk) **Legal Settlement Accruals (June 30, 2025, kUSD):** | Category | Value | | :--------------------------------------- | :---- | | FERC Matters | 1,065 | | Stronghold Shareholder Securities Lawsuit | 2,036 | | **Total settlement accruals** | **3,101** | - Scrubgrass agreed to a settlement of **$1,420k** for FERC matters, with **$1,065k** remaining to be paid in installments as of June 30, 2025[147](index=147&type=chunk) - The Stronghold shareholder securities lawsuit settlement involves **$4,750k cash** and **25 BTC**, with **$2,036k** (representing 19 remaining BTC) accrued as of June 30, 2025[149](index=149&type=chunk) - A new class action lawsuit, Olympio v. Bitfarms Ltd., was filed on May 9, 2025, alleging violations of the Securities Exchange Act, but the company is currently unable to estimate the reasonably possible loss[150](index=150&type=chunk) [29. Subsequent Events](index=48&type=section&id=29.%20Subsequent%20Events) Subsequent events include a Miner swap, a share buyback program repurchasing 4.9 million shares, land purchases, and the decision to discontinue Rio Cuarto, Argentina operations by November 2025 - In July 2025, the company entered a Miner swap agreement, returning **10,467 Bitmain T21 Miners** for a **$23,865k credit** and purchasing **8,585 Bitmain S21+ Miners** for **$29,831k**[151](index=151&type=chunk) - The TSX approved a Corporate Share Buyback Program (NCIB) on July 22, 2025, allowing the repurchase of up to **49,943,031 common shares**; by August 11, 2025, **4,949,244 shares** were repurchased for **$6,147k**[153](index=153&type=chunk)[155](index=155&type=chunk) - Agreements were made in August 2025 to purchase **3 acres of land in Washington State** for **$1,898k** and **181 acres in Pennsylvania** for **$3,500k**[156](index=156&type=chunk)[157](index=157&type=chunk) - The company determined to discontinue its Bitcoin data center operations in Rio Cuarto, Argentina, by November 11, 2025, due to halted energy supply and future economic uncertainty; an agreement with GMSA includes repayment of a **$3,500k energy deposit** and elimination of a **$2,807k asset retirement obligation**[159](index=159&type=chunk)[160](index=160&type=chunk)
Madison Square Garden Sports (MSGS) - 2025 Q4 - Annual Results
2025-08-12 11:46
MADISON SQUARE GARDEN SPORTS CORP. REPORTS FISCAL 2025 FOURTH QUARTER AND FULL-YEAR RESULTS The fiscal 2025 fourth quarter was highlighted by the New York Knicks' (the "Knicks") participation in the NBA playoffs, which included nine home playoff games at the Madison Square Garden Arena ("The Garden") and culminated with the team's appearance in the Eastern Conference Finals. This compared to fifteen combined home playoff games for the Knicks and the New York Rangers (the "Rangers") in the prior year quarter ...
ADC Therapeutics(ADCT) - 2025 Q2 - Quarterly Results
2025-08-12 11:41
[Key Highlights and Strategic Overview](index=1&type=section&id=Key%20Highlights%20and%20Strategic%20Overview) ADC Therapeutics reported strong Q2 2025 results, with ZYNLONTA® showing **93.3% ORR** and a **$100 million** private placement extending cash runway - ZYNLONTA® in combination with glofitamab (LOTIS-7 trial) demonstrated a **93.3% overall response rate (ORR)** and an **86.7% complete response (CR) rate** in 30 efficacy evaluable patients with relapsed/refractory DLBCL[1](index=1&type=chunk)[3](index=3&type=chunk) - Completed a **$100 million private placement (PIPE financing)**, securing net proceeds of **$93.1 million** and extending the company's expected cash runway into 2028[1](index=1&type=chunk)[3](index=3&type=chunk) - The company has streamlined its strategic focus to pursue the expansion of ZYNLONTA® into earlier lines of therapy, leveraging its strengthened financial foundation[2](index=2&type=chunk) [Operational and Clinical Development Updates](index=1&type=section&id=Operational%20and%20Clinical%20Development%20Updates) The company advances ZYNLONTA® clinical programs and a new PSMA-targeting ADC, while restructuring to focus resources and reduce its workforce by **30%** [ZYNLONTA® Clinical Programs](index=1&type=section&id=ZYNLONTA%C2%AE%20Clinical%20Programs) ZYNLONTA® showed high efficacy in LOTIS-7 for r/r DLBCL, with FDA engagement planned, while LOTIS-5 is on track for 2025 completion, and an investigator-initiated trial showed **84.6% ORR** in marginal zone lymphoma - LOTIS-7 (ZYNLONTA® + glofitamab): The Phase 1b trial is being expanded to **100 patients** with r/r DLBCL following strong efficacy data (**93.3% ORR, 86.7% CR**), with plans to engage with the FDA in H2 2025[1](index=1&type=chunk)[3](index=3&type=chunk) - LOTIS-5 (ZYNLONTA® + rituximab): The Phase 3 confirmatory trial is expected to reach its prespecified progression-free survival (PFS) events by the end of 2025, with a potential sBLA submission anticipated in H1 2026[1](index=1&type=chunk)[5](index=5&type=chunk) - Marginal Zone Lymphoma: An investigator-initiated trial of ZYNLONTA® monotherapy demonstrated an **ORR of 84.6%** and a **CR of 69.2%** in 26 patients, with plans to assess a potential regulatory pathway[5](index=5&type=chunk) [Pipeline and Corporate Strategy](index=2&type=section&id=Pipeline%20and%20Corporate%20Strategy) The company advances a new PSMA-targeting ADC, with IND-enabling activities concluding by year-end 2025, while strategically restructuring to focus on ZYNLONTA® and reduce its global workforce by **30%** - A new exatecan-based, prostate-specific membrane antigen (PSMA)-targeting ADC is advancing, with IND-enabling activities expected to be completed by the end of 2025[5](index=5&type=chunk) - Announced a strategic restructuring to focus on ZYNLONTA®, which includes discontinuing early solid tumor programs, shutting down the UK facility, and reducing the global workforce by approximately **30%**[5](index=5&type=chunk) [Second Quarter and First Half 2025 Financial Results](index=2&type=section&id=Second%20Quarter%20and%20First%20Half%202025%20Financial%20Results) ADC Therapeutics reported Q2 2025 net product revenues of **$18.1 million**, with net loss widening to **$56.6 million** due to increased R&D and **$13.1 million** restructuring costs, ending with **$264.6 million** cash Q2 & H1 2025 Key Financial Metrics (in millions USD, except per share data) | Metric | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--- | :--- | :--- | :--- | :--- | | **Product Revenues, Net** | $18.1 | $17.0 | $35.5 | $34.9 | | **Total Operating Expense** | $63.0 | $46.5 | $114.5 | $98.1 | | **R&D Expense** | $30.1 | $24.3 | $59.0 | $50.0 | | **Restructuring Costs** | $13.1 | $0.0 | $13.1 | $0.0 | | **Net Loss** | ($56.6) | ($36.5) | ($95.2) | ($83.2) | | **Net Loss Per Share** | ($0.50) | ($0.38) | ($0.86) | ($0.93) | | **Adjusted Net Loss** | ($28.7) | ($24.4) | ($52.6) | ($55.5) | | **Adjusted Net Loss Per Share**| ($0.25) | ($0.25) | ($0.48) | ($0.62) | - The increase in R&D expenses was driven by the timing and enrollment of the ZYNLONTA® clinical trials LOTIS-5 and LOTIS-7, and IND-enabling activities for the PSMA-targeting ADC[5](index=5&type=chunk) - The company incurred **$13.1 million** in restructuring and impairment costs in Q2 2025, consisting of **$6.7 million** in employee severance and **$6.4 million** in non-cash asset impairments related to the UK facility closure[5](index=5&type=chunk)[6](index=6&type=chunk) - Cash and cash equivalents stood at **$264.6 million** as of June 30, 2025, compared to **$250.9 million** at the end of 2024, with the increase primarily due to the **$100 million PIPE financing**[10](index=10&type=chunk) [Appendix: Financial Statements](index=7&type=section&id=Appendix%3A%20Financial%20Statements) This section presents unaudited condensed consolidated financial statements for Q2 and H1 2025, including Statements of Operations, Balance Sheets, and a detailed reconciliation of GAAP to Non-GAAP financial measures [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This statement details the company's revenues, operating expenses, and other income/expenses, culminating in a net loss of **$56.6 million** for Q2 2025 and **$95.2 million** for H1 2025 Condensed Consolidated Statements of Operations (Unaudited, in thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | **Total revenue, net** | $18,839 | $17,410 | $41,872 | $35,463 | | **Total operating expense** | $(62,986) | $(46,451) | $(114,483) | $(98,117) | | **Loss from operations** | $(44,147) | $(29,041) | $(72,611) | $(62,654) | | **Net loss** | $(56,646) | $(36,544) | $(95,248) | $(83,150) | | **Net loss per share, basic and diluted** | $(0.50) | $(0.38) | $(0.86) | $(0.93) | [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2025, shows total assets of **$321.6 million**, total liabilities of **$520.7 million**, and a total shareholders' deficit of **$199.2 million**, with cash at **$264.6 million** Condensed Consolidated Balance Sheets (Unaudited, in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $264,560 | $250,867 | | Total current assets | $318,755 | $307,390 | | **Total assets** | **$321,561** | **$321,980** | | **LIABILITIES AND SHAREHOLDERS' (DEFICIT) EQUITY** | | | | Total current liabilities | $64,600 | $80,469 | | **Total liabilities** | **$520,745** | **$524,622** | | **Total shareholders' (deficit) equity** | **$(199,184)** | **$(202,642)** | [Reconciliation of GAAP to Non-GAAP Measures](index=10&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Measures) This table reconciles GAAP net loss to non-GAAP adjusted net loss, showing Q2 2025 GAAP net loss of **$56.6 million** adjusted to **$28.7 million** after specific non-cash and restructuring items Reconciliation of Net Loss to Adjusted Net Loss (Unaudited, in thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | **Net loss (GAAP)** | **$(56,646)** | **$(36,544)** | **$(95,248)** | **$(83,150)** | | Share-based compensation expense | $2,062 | $1,988 | $4,483 | $2,146 | | Restructuring charges | $6,677 | $— | $6,677 | $— | | Impairment charges | $6,414 | $— | $6,414 | $— | | Other non-cash/non-recurring items | $12,813 | $10,216 | $25,031 | $24,853 | | **Adjusted net loss (Non-GAAP)** | **$(28,680)** | **$(24,370)** | **$(52,643)** | **$(55,517)** |
Bicara Therapeutics Inc.(BCAX) - 2025 Q2 - Quarterly Results
2025-08-12 11:41
Bicara Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update Updated data from Phase 1/1b trial presented at 2025 ASCO Annual Meeting demonstrated deep and durable responses in 1L HPV-negative R/M HNSCC Data from additional Phase 1/1b expansion cohorts evaluating alternate dose regimens in HPV-negative patients expected by Q1 2026 Strong financial position with approximately $437 million in cash and cash equivalents as of June 30, 2025 expected to fund operations into the f ...