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Ainos(AIMD) - 2025 Q2 - Quarterly Report
2025-08-13 20:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from____to____ Commission File No. 001-41461 AINOS, INC. (Exact name of registrant as specified in its charter) | TEXAS | 75-1974352 | | --- | --- | | (State or oth ...
1RT Acquisition Corp Unit(ONCHU) - 2025 Q2 - Quarterly Report
2025-08-13 20:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (MARK ONE) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarter ended June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-42731 1RT Acquisition Corp. (Exact Name of Registrant as Specified in Its Charter) | Cayman Islands | 33-1579459 | | --- | --- | | (State or ...
Hyperfine(HYPR) - 2025 Q2 - Quarterly Report
2025-08-13 20:15
FORM 10-Q Filing Information [Registrant Information](index=1&type=section&id=Registrant%20Information) Provides the basic identification details for Hyperfine, Inc, including its legal name, jurisdiction of incorporation, address, telephone number, and SEC filing status - Hyperfine, Inc. is incorporated in Delaware with its principal executive offices in Guilford, Connecticut[2](index=2&type=chunk) Registrant Information | Indicator | Value | | :---------- | :---- | | Commission File Number | 001-39949 | | Filer Status | Non-accelerated filer, Smaller reporting company, Emerging growth company | | Class A Common Stock Outstanding (as of Aug 1, 2025) | 63,525,713 shares | | Class B Common Stock Outstanding (as of Aug 1, 2025) | 15,055,288 shares | Cautionary Statement Regarding Forward-Looking Statements [Nature of Forward-Looking Statements](index=3&type=section&id=Nature%20of%20Forward-Looking%20Statements) The report contains forward-looking statements based on management's beliefs and assumptions, which are inherently subject to risks and are not guarantees of future performance - Forward-looking statements relate to future events or financial performance, including plans, strategies, and prospects[8](index=8&type=chunk) - Statements are based on management's beliefs and assumptions, but **actual results may differ** due to inherent risks and uncertainties[8](index=8&type=chunk) [Key Areas of Forward-Looking Statements](index=3&type=section&id=Key%20Areas%20of%20Forward-Looking%20Statements) Forward-looking statements cover critical aspects of the Company's operations, including product development, commercialization, regulatory approvals, and financial performance - Success, cost, and timing of product development activities[8](index=8&type=chunk) - Commercialization and adoption of existing and future product offerings[8](index=8&type=chunk) - Ability to obtain and maintain regulatory approval for products[8](index=8&type=chunk) - Size and growth potential of markets for products and services[9](index=9&type=chunk) - History of losses and ability to continue as a going concern[9](index=9&type=chunk) - Estimates regarding expenses, revenue, capital requirements, and needs for additional financing[9](index=9&type=chunk) - Impact of market conditions, global and economic factors (inflation, geopolitical conflicts, export controls, tariffs)[10](index=10&type=chunk) - Intense competition and competitive pressures[10](index=10&type=chunk) - Ability to retain or recruit key employees and directors[10](index=10&type=chunk) PART I — FINANCIAL INFORMATION [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Presents the unaudited condensed consolidated financial statements for Hyperfine, Inc, including balance sheets, statements of operations, and cash flows, with detailed notes [Condensed Consolidated Balance Sheets (unaudited)](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(unaudited)) Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | **ASSETS** | | | | Cash and cash equivalents | $25,420 | $37,645 | | Total current assets | $40,096 | $53,710 | | Total assets | $45,234 | $58,901 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Total current liabilities | $7,988 | $8,729 | | Warrant liabilities | $1,194 | — | | Total liabilities | $10,108 | $9,861 | | Total stockholders' equity | $35,126 | $49,040 | - **Total assets decreased by $13,667 thousand (23.2%)** from December 31, 2024, to June 30, 2025, primarily due to a decrease in cash and cash equivalents[13](index=13&type=chunk) - **Total stockholders' equity decreased by $13,914 thousand (28.4%)** from December 31, 2024, to June 30, 2025, mainly due to accumulated deficit[13](index=13&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20(unaudited)) Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | 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 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total sales | $2,696 | $3,631 | $4,833 | $6,926 | | Total cost of sales | $1,368 | $1,828 | $2,622 | $3,769 | | Gross margin | $1,328 | $1,803 | $2,211 | $3,157 | | Total operating expenses | $10,923 | $12,649 | $22,708 | $24,653 | | Loss from operations | $(9,595) | $(10,846) | $(20,497) | $(21,496) | | Net loss and comprehensive loss | $(9,225) | $(10,156) | $(18,643) | $(20,004) | | Net loss per common share, basic and diluted | $(0.12) | $(0.14) | $(0.24) | $(0.28) | - **Total sales decreased by 25.8%** for the three months ended June 30, 2025, and by **30.2%** for the six months ended June 30, 2025, compared to the respective prior periods[16](index=16&type=chunk) - **Net loss improved by 9.2%** for the three months ended June 30, 2025, and by **6.8%** for the six months ended June 30, 2025, compared to the respective prior periods[16](index=16&type=chunk) - **Operating expenses decreased by 13.6%** for the three months ended June 30, 2025, and by **7.9%** for the six months ended June 30, 2025, primarily due to reduced R&D and G&A expenses[16](index=16&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity (unaudited)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity%20(unaudited)) Changes in Stockholders' Equity (in thousands, except share amounts) | Metric | Balance, Dec 31, 2024 | Net Loss (Q1 2025) | Issuance of common stock and warrants, net | Stock-based compensation expense (Q1 2025) | Balance, Mar 31, 2025 | Net Loss (Q2 2025) | Stock-based compensation expense (Q2 2025) | Balance, June 30, 2025 | | :--------------------------------------- | :-------------------- | :------------------- | :----------------------------------------- | :--------------------------------------- | :-------------------- | :------------------- | :--------------------------------------- | :--------------------- | | Total Stockholders' Equity | $49,040 | $(9,418) | $2,385 | $945 | $43,114 | $(9,225) | $547 | $35,126 | - **Total stockholders' equity decreased** from $49,040 thousand at December 31, 2024, to **$35,126 thousand** at June 30, 2025, primarily due to net losses[19](index=19&type=chunk) - The company issued **4,511,278 shares of Class A common stock and warrants**, generating **$2,385 thousand** in additional paid-in capital during the first quarter of 2025[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows (unaudited)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(unaudited)) Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(17,159) | $(21,893) | | Net cash used in investing activities | $(992) | $(216) | | Net cash provided by financing activities | $6,056 | $114 | | Net decrease in cash and cash equivalents and restricted cash | $(12,095) | $(21,995) | | Cash, cash equivalents and restricted cash, end of period | $25,578 | $53,809 | - **Net cash used in operating activities decreased by $4,734 thousand (21.6%)** for the six months ended June 30, 2025, compared to the same period in 2024[23](index=23&type=chunk) - **Net cash provided by financing activities significantly increased to $6,056 thousand** in 2025, primarily due to proceeds from common stock and warrant issuance[23](index=23&type=chunk) - Overall **net decrease in cash and cash equivalents and restricted cash improved by $9,900 thousand (45.0%)** in 2025 compared to 2024[23](index=23&type=chunk) [Notes to Condensed Consolidated Financial Statements (unaudited)](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) [1. Organization and Description of Business](index=9&type=section&id=1.%20ORGANIZATION%20AND%20DESCRIPTION%20OF%20BUSINESS) Hyperfine, Inc develops and commercializes the AI-powered portable ultra-low-field (ULF) MR brain imaging Swoop® system, which has multiple FDA clearances and international marketing authorizations - Hyperfine, Inc develops AI-powered portable ultra-low-field (ULF) MR brain imaging systems, specifically the Swoop® system[25](index=25&type=chunk) - Received initial FDA 510(k) clearance for brain imaging in 2020[26](index=26&type=chunk) - Received 510(k) clearance for ninth-generation AI-powered software in July 2024, reducing scan times[26](index=26&type=chunk) - Received 510(k) clearance for tenth-generation Optive AI™ software in May 2025, enhancing image clarity and detail[27](index=27&type=chunk) - Next-generation Swoop® system with Optive AI™ software features new hardware for highest signal-to-noise ratio and exceptional image quality[27](index=27&type=chunk) - Swoop® system has marketing authorization in EU (CE Mark), UK (UKCA Mark), Canada, Australia, and New Zealand[28](index=28&type=chunk) [2. Summary of Significant Accounting Policies](index=10&type=section&id=2.%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) Outlines the company's accounting policies, going concern assumption, risks, and use of significant estimates in financial reporting - The financial statements are prepared on a going concern basis, but the company has limited revenues and a history of negative working capital, requiring future financing[29](index=29&type=chunk)[30](index=30&type=chunk) - Subject to risks from geopolitical and macroeconomic impacts (conflicts, inflation, tariffs)[35](index=35&type=chunk) - Relies on single-source manufacturers and suppliers, posing supply chain disruption risks[36](index=36&type=chunk) - Cash and cash equivalents are deposited with major financial institutions, exceeding insured amounts at times[43](index=43&type=chunk) - Significant estimates include revenue recognition, allowance for credit losses, inventory valuation, deferred tax assets, stock-based compensation, and warrant liabilities valuation[43](index=43&type=chunk) Customer Concentration (Revenue > 10%) | Period | Number of Customers | Revenue Contribution (in thousands) | | :-------------------------------- | :------------------ | :-------------------------------- | | Three Months Ended June 30, 2025 | 4 | $402, $362, $321, $310 | | Six Months Ended June 30, 2025 | None | N/A | | Three Months Ended June 30, 2024 | 4 | $721, $434, $394, $378 | | Six Months Ended June 30, 2024 | 2 | $1,146, $721 | - A new accounting pronouncement, ASU 2024-03, on expense disaggregation disclosures, is effective for fiscal years beginning after December 15, 2026, and is currently being evaluated for impact[42](index=42&type=chunk) [3. Revenue Recognition](index=13&type=section&id=3.%20REVENUE%20RECOGNITION) Details revenue disaggregation by product type, recognition timing, and remaining performance obligations Disaggregated Revenue (in thousands) | Revenue Type | Recognition Pattern | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------- | :------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Device | Point in time | $2,128 | $2,970 | $3,650 | $5,674 | | Service | Over time | $568 | $661 | $1,183 | $1,252 | | Total revenue | | $2,696 | $3,631 | $4,833 | $6,926 | Contract Balances (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Accounts receivable, net | $5,057 | $5,956 | | Unbilled receivables - current | $1,892 | $2,349 | | Unbilled receivables - non-current | $937 | $825 | | Deferred revenue | $1,370 | $1,460 | | Long term deferred revenue | $914 | $1,054 | - Revenue recognized from beginning deferred revenue balance: **$430 thousand** (Q2 2025), **$829 thousand** (H1 2025), **$489 thousand** (Q2 2024), **$879 thousand** (H1 2024)[49](index=49&type=chunk) - Remaining performance obligations: **$5,939 thousand** (June 30, 2025) vs **$5,644 thousand** (Dec 31, 2024)[50](index=50&type=chunk) - Expects to recognize **~17%** of remaining performance obligations in FY2025 and **~83%** in FY2026 and thereafter[55](index=55&type=chunk) [4. Fair Value of Financial Instruments](index=15&type=section&id=4.%20FAIR%20VALUE%20OF%20FINANCIAL%20INSTRUMENTS) Financial instruments are measured at fair value using a three-tier hierarchy, with warrant liabilities classified as Level 3 - Cash and cash equivalents are measured at fair value using **Level 1 inputs** (quoted prices in active markets)[61](index=61&type=chunk) Warrant Liabilities Fair Value (in thousands) | Date | Fair Value | | :---------------- | :--------- | | June 30, 2025 | $1,194 | | February 12, 2025 | $2,858 | - Warrant liabilities are measured at fair value using **Level 3 inputs**, with a decrease in fair value from February 12, 2025, to June 30, 2025, primarily due to changes in Class A common stock price[61](index=61&type=chunk)[135](index=135&type=chunk) [5. Inventories](index=16&type=section&id=5.%20INVENTORIES) Details the composition of inventory, which consists of raw materials and finished goods, and shows a decrease in total value Inventories (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :----------- | :------------ | :---------------- | | Raw materials | $2,463 | $3,070 | | Finished goods | $2,419 | $2,762 | | Total inventories | $4,882 | $5,832 | - **Total inventories decreased by $950 thousand (16.3%)** from December 31, 2024, to June 30, 2025[63](index=63&type=chunk) [6. Property and Equipment, Net](index=16&type=section&id=6.%20PROPERTY%20AND%20EQUIPMENT,%20NET) Property and equipment, net, remained stable, with depreciation expense detailed for the reporting periods Property and Equipment, Net (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Total historical cost | $7,163 | $6,679 | | Less: Accumulated depreciation | $(4,041) | $(3,557) | | Property and equipment, net | $3,122 | $3,122 | Depreciation Expense (in thousands) | Period | 2025 | 2024 | | :-------------------------------- | :--- | :--- | | Three Months Ended June 30, | $283 | $253 | | Six Months Ended June 30, | $512 | $516 | [7. Right-of-Use (ROU) Assets and Leases Liabilities](index=17&type=section&id=7.%20RIGHT-OF-USE%20(ROU)%20ASSETS%20AND%20LEASES%20LIABILITIES) Details operating lease ROU assets and liabilities for corporate offices and a warehouse Operating Lease Balances (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Operating lease ROU assets | $254 | $341 | | Current lease liabilities | $238 | $269 | | Non-current lease liabilities | $12 | $78 | - Weighted-average remaining lease term: **14 months**[67](index=67&type=chunk) - Annual weighted-average discount rate: **9.78%**[67](index=67&type=chunk) - Future minimum commitments: **$136 thousand** for 2025 and **$114 thousand** thereafter[68](index=68&type=chunk) [8. Accrued Expenses and Other Current Liabilities](index=17&type=section&id=8.%20ACCRUED%20EXPENSES%20AND%20OTHER%20CURRENT%20LIABILITIES) Accrued expenses and other current liabilities decreased, driven primarily by lower bonuses and contracted services Accrued Expenses and Other Current Liabilities (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Bonuses | $1,277 | $2,144 | | Contracted services | $657 | $1,755 | | Legal fees | $474 | $176 | | Payroll and related benefits | $559 | $756 | | Operating lease liabilities | $238 | $269 | | Other | $225 | $473 | | Total | $3,430 | $5,573 | - The decrease of **$2,143 thousand (38.4%)** was mainly driven by lower bonuses and contracted services[69](index=69&type=chunk) [9. Stockholders' Equity](index=17&type=section&id=9.%20STOCKHOLDERS%27%20EQUITY) Details changes in stockholders' equity, including capital raised from stock offerings and equity plan activity - Under the ATM program, **1,579,912 Class A common shares** were issued as of June 30, 2025, for net proceeds of **$1,633 thousand**[71](index=71&type=chunk) - In February 2025, the company issued **4,511,278 Class A common shares and warrants** in a registered direct offering, generating **$6,000 thousand** in gross proceeds[72](index=72&type=chunk) - **Outstanding stock options decreased** from 18,396,536 at January 1, 2025, to **17,016,565** at June 30, 2025, due to exercises and forfeitures/cancellations[74](index=74&type=chunk) - **Outstanding RSUs increased significantly** from 138,902 at January 1, 2025, to **2,567,691** at June 30, 2025, primarily due to new hire and annual employee grants[79](index=79&type=chunk) Stock-Based Compensation Expense (in thousands) | Functional Line Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Cost of sales | $48 | $24 | $66 | $48 | | Research and development | $367 | $387 | $712 | $724 | | Sales and marketing | $71 | $47 | $134 | $86 | | General and administrative | $61 | $716 | $580 | $1,348 | | Total | $547 | $1,174 | $1,492 | $2,206 | [10. Net Loss Per Share](index=19&type=section&id=10.%20NET%20LOSS%20PER%20SHARE) Reports basic and diluted net loss per share, noting that all common equivalent shares were anti-dilutive Net Loss Per Share (Basic and Diluted) | 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 | | :------------------------------------------------------------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net Loss (in thousands) | $(9,225) | $(10,156) | $(18,643) | $(20,004) | | Weighted-average shares used to compute net loss per share (basic and diluted) | 78,077,118 | 72,041,332 | 76,893,733 | 71,987,688 | | Basic and dilutive net loss per share | $(0.12) | $(0.14) | $(0.24) | $(0.28) | - The inclusion of outstanding stock options, RSUs, and warrants would have been **anti-dilutive** for all periods presented due to the net loss position[81](index=81&type=chunk)[83](index=83&type=chunk) [11. Income Taxes](index=20&type=section&id=11.%20INCOME%20TAXES) The effective income tax rate was 0.0% due to a full valuation allowance against net deferred tax assets - The effective tax rate was **0.0%** for the three and six months ended June 30, 2025, due to a full valuation allowance against deferred tax assets[85](index=85&type=chunk)[86](index=86&type=chunk) - The primary reconciling items to the federal statutory rate of 21.0% were deferred state income taxes, R&D credits, stock-based compensation, and the valuation allowance[85](index=85&type=chunk) - The One Big Beautiful Bill Act (OBBBA), enacted on July 4, 2025, will be evaluated for its impact on future tax rates[87](index=87&type=chunk) [12. Related Party Transactions](index=21&type=section&id=12.%20RELATED%20PARTY%20TRANSACTIONS) Details related party transactions with 4Catalyzer Corporation (4C) for office space and administrative services Related Party Payments to 4C (in thousands) | Service | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2024 | | :---------------- | :------------------------------- | :----------------------------- | :------------------------------- | :----------------------------- | | Rent | $115 | $203 | $120 | $248 | | Master Services Agreement | $33 | $58 | $31 | $65 | - As of June 30, 2025, **$59 thousand** was due to 4C for expenses paid on Hyperfine's behalf[89](index=89&type=chunk) [13. Commitments and Contingencies](index=21&type=section&id=13.%20COMMITMENTS%20AND%20CONTINGENCIES) Outlines commitments related to a 401(k) plan, BMGF grants, and purchase orders, with no material legal contingencies - No matching contributions were made to the 401(k) plan for the reported periods[90](index=90&type=chunk) - Awarded **$4.9 million** in grants from BMGF (2020-2021) for deploying 25 Swoop® systems for a multi-site study, completed by February 2024[91](index=91&type=chunk) - Awarded an additional **$3.354 million** BMGF grant in May 2023 to develop scalable neurodevelopment measurement via ULF MRI in neonates/infants in low-to-middle income countries through February 2026[91](index=91&type=chunk) - During H1 2025, completed **$492 thousand** in grant deliverables and received **$616 thousand** in cash funding[92](index=92&type=chunk) - As of June 30, 2025, restricted cash of **$158 thousand** was offset by deferred grant funding[92](index=92&type=chunk) - Purchase commitments are primarily short-term and generally allow for cancellation or rescheduling[92](index=92&type=chunk) - The company is not a party to any material litigation and has not recorded any liability for indemnification obligations[93](index=93&type=chunk)[94](index=94&type=chunk) [14. Reportable Segments and Geographic Information](index=22&type=section&id=14.%20REPORTABLE%20SEGMENTS%20AND%20GEOGRAPHIC%20INFORMATION) The company operates as a single business segment with all long-lived assets located in the United States - The company operates in **one business segment**, managed by the CEO as the chief operating decision maker[95](index=95&type=chunk) - All long-lived assets are located in the **United States**[96](index=96&type=chunk) Non-U.S. Revenue (in thousands) | Period | 2025 | 2024 | | :-------------------------------- | :--- | :--- | | Three Months Ended June 30, | $492 | $1,901 | | Six Months Ended June 30, | $1,566 | $4,335 | [15. Subsequent Events](index=22&type=section&id=15.%20SUBSEQUENT%20EVENTS) No subsequent events requiring disclosure were identified through the financial statement issuance date - No subsequent events requiring disclosure were identified through the financial statement issuance date[97](index=97&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Provides management's perspective on financial condition, results of operations, key performance metrics, and critical accounting policies [Overview](index=23&type=section&id=Overview) Hyperfine is a health technology company commercializing its AI-powered portable ULF MR brain imaging Swoop® system to increase access to MRI in various care settings - Hyperfine's mission is to revolutionize patient care globally through accessible, affordable, AI-powered portable ULF MR brain imaging with the Swoop® system[100](index=100&type=chunk) - Swoop® system is the **first FDA-cleared, portable, ULF, MR brain imaging system**[101](index=101&type=chunk) - Estimated U.S. total addressable market for Swoop® system device placements is **over $16 billion**[102](index=102&type=chunk) - The system integrates deep learning (AI) to enhance image quality and reduce scan artifacts[103](index=103&type=chunk) - Received FDA 510(k) clearance for ninth-generation software (July 2024) and tenth-generation Optive AI™ software (May 2025), improving scan times and image clarity[105](index=105&type=chunk) - Next-generation Swoop® system with Optive AI™ software features new hardware for exceptional low-field MRI image quality[106](index=106&type=chunk) [Key Performance Metrics](index=24&type=section&id=Key%20Performance%20Metrics) Management monitors total revenues and Swoop® system units sold, both of which decreased year-over-year Key Performance Metrics | 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 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenues (in millions) | $2.7 | $3.6 | $4.8 | $6.9 | | Total Swoop® system units sold | 8 | 13 | 14 | 26 | - **Total revenues decreased by 25.8% (Q2) and 30.2% (H1) YoY**, primarily due to fewer units sold[109](index=109&type=chunk) - **Total Swoop® system units sold decreased by 38.5% (Q2) and 46.2% (H1) YoY**[109](index=109&type=chunk) [Factors Affecting Results of Operations](index=24&type=section&id=Factors%20Affecting%20Results%20of%20Operations) Key factors influencing results include technical innovation, U.S. commercialization, and global expansion - Continuous investment in technical innovation, including AI and cloud technology, to improve image quality and develop new applications[110](index=110&type=chunk) - U.S. commercialization efforts expanding beyond critical care to emergency departments and neurology clinics, supported by the next-generation Swoop® system with Optive AI™ software[111](index=111&type=chunk) - International expansion in Canada, Europe, Australia, and New Zealand, bolstered by CE Mark and UKCA Mark approval for ninth-generation software[112](index=112&type=chunk)[113](index=113&type=chunk) - Grant funding from the Bill and Melinda Gates Foundation (BMGF) supports global expansion and deployment of Swoop® systems in low-to-middle income countries for neurodevelopment research[114](index=114&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Compares results of operations year-over-year, showing decreased sales but an improved net loss due to reduced operating expenses and a gain from warrant liabilities Sales Performance (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (%) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (%) | | :---------- | :------------------------------- | :------------------------------- | :--------- | :----------------------------- | :----------------------------- | :--------- | | Device sales | $2,128 | $2,970 | (28.4)% | $3,650 | $5,674 | (35.7)% | | Service sales | $568 | $661 | (14.1)% | $1,183 | $1,252 | (5.5)% | | Total sales | $2,696 | $3,631 | (25.8)% | $4,833 | $6,926 | (30.2)% | - **Device sales decreased** primarily due to lower units sold, partially offset by an increase in average selling price[118](index=118&type=chunk)[119](index=119&type=chunk) - **Service sales decreased** due to one-time revenue in 2024 and a subscription business model in prior years[120](index=120&type=chunk)[121](index=121&type=chunk) Cost of Sales Performance (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (%) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (%) | | :---------------- | :------------------------------- | :------------------------------- | :--------- | :----------------------------- | :----------------------------- | :--------- | | Device cost of sales | $1,097 | $1,422 | (22.9)% | $2,082 | $2,921 | (28.7)% | | Service cost of sales | $271 | $406 | (33.3)% | $540 | $848 | (36.3)% | | Total cost of sales | $1,368 | $1,828 | (25.2)% | $2,622 | $3,769 | (30.4)% | | Percentage of revenue | 50.7% | 50.3% | | 54.3% | 54.4% | | - **Cost of device sales decreased** due to lower units sold[122](index=122&type=chunk)[123](index=123&type=chunk) - **Cost of service sales decreased** due to lower headcount and infrastructure costs[124](index=124&type=chunk) Operating Expenses (in thousands) | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (%) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (%) | | :----------------------- | :------------------------------- | :------------------------------- | :--------- | :----------------------------- | :----------------------------- | :--------- | | Research and development | $4,541 | $5,959 | (23.8)% | $9,578 | $11,529 | (16.9)% | | General and administrative | $3,859 | $4,421 | (12.7)% | $8,067 | $8,851 | (8.9)% | | Sales and marketing | $2,523 | $2,269 | 11.2% | $5,063 | $4,273 | 18.5% | | Total operating expenses | $10,923 | $12,649 | (13.6)% | $22,708 | $24,653 | (7.9)% | - **R&D expenses decreased** due to lower headcount and consulting expenses[125](index=125&type=chunk)[126](index=126&type=chunk) - **G&A expenses decreased** primarily due to lower stock-based compensation[128](index=128&type=chunk)[129](index=129&type=chunk) - **Sales and marketing expenses increased** due to higher salary and benefits and marketing expenses[130](index=130&type=chunk)[131](index=131&type=chunk) Other Income/Expense (in thousands) | Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (%) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (%) | | :-------------------------------- | :------------------------------- | :------------------------------- | :--------- | :----------------------------- | :----------------------------- | :--------- | | Interest income | $239 | $675 | (64.6)% | $556 | $1,471 | (62.2)% | | Change in fair value of warrant liabilities | $46 | — | NM | $1,664 | — | NM | | Other income (expense), net | $85 | $15 | NM | $(366) | $21 | NM | - **Interest income decreased** due to lower cash balances[132](index=132&type=chunk)[133](index=133&type=chunk) - **Gain from change in fair value of warrant liabilities (H1 2025) was $1.7 million**, primarily due to changes in Class A common stock price[134](index=134&type=chunk)[135](index=135&type=chunk) - **Other income (expense), net, decreased** for H1 2025 due to financing costs allocated to warrant liabilities, partially offset by favorable foreign exchange[136](index=136&type=chunk)[137](index=137&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) The company has a history of net losses and expects existing cash to fund operations for at least 12 months, but may require additional financing - Funded operations primarily through common stock, preferred stock, and warrants[138](index=138&type=chunk) - Incurred a **net loss of $18.6 million** for H1 2025 and an **accumulated deficit of $313.1 million** as of June 30, 2025[139](index=139&type=chunk) - Cash and cash equivalents: **$25.4 million** as of June 30, 2025[139](index=139&type=chunk) - Expects existing cash and sales to fund operations for **at least 12 months**, but future cash needs may accelerate[140](index=140&type=chunk) - Filed a **$150 million shelf registration statement** in November 2023, including a **$50 million 'at-the-market' (ATM) equity program**[141](index=141&type=chunk) - Under ATM, **1,579,912 shares** of Class A common stock sold for **$1,633 thousand net proceeds** as of June 30, 2025[141](index=141&type=chunk) - Closed a **$6.0 million gross proceeds** registered direct offering of 4,511,278 Class A common shares and warrants in February 2025[141](index=141&type=chunk) - Future cash requirements depend on market adoption, sales/marketing expansion, R&D costs, regulatory approvals, and competitive developments; inability to obtain additional funds could lead to delays or cessation of operations[143](index=143&type=chunk)[144](index=144&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(17,159) | $(21,893) | | Net cash used in investing activities | $(992) | $(216) | | Net cash provided by financing activities | $6,056 | $114 | | Net decrease in cash, cash equivalents, and restricted cash | $(12,095) | $(21,995) | - **Net cash used in operating activities decreased** due to lower net loss and favorable changes in working capital[146](index=146&type=chunk)[147](index=147&type=chunk) - **Net cash used in investing activities increased** due to higher purchases of property and equipment[149](index=149&type=chunk)[150](index=150&type=chunk) - **Net cash provided by financing activities significantly increased** due to proceeds from the issuance of common stock and warrants[151](index=151&type=chunk)[152](index=152&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=32&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) No material changes were made to critical accounting policies, which rely on significant estimates and assumptions - Financial statements require significant estimates and assumptions, which are evaluated on an ongoing basis[157](index=157&type=chunk) - No material changes to critical accounting policies were reported, except for the evaluation of ASU 2024-03[158](index=158&type=chunk)[159](index=159&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risks from interest rates, inflation, and foreign exchange fluctuations - **Interest Rate Risk:** Primarily affects cash, cash equivalents, and restricted cash; a 0.5 percentage point decrease in interest rates would decrease earnings before income taxes by **$0.1 million** annually[161](index=161&type=chunk)[162](index=162&type=chunk) - **Inflation Risk:** Not deemed to have a material effect on the business, but inability to offset higher costs through price increases could be harmful[163](index=163&type=chunk) - **Foreign Exchange Risk:** Limited exposure as most transactions are in U.S. dollars; no hedging strategies are currently utilized[164](index=164&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were deemed effective, with no material changes to internal controls - Disclosure controls and procedures were **effective** at a reasonable assurance level as of June 30, 2025[165](index=165&type=chunk) - **No material changes** in internal control over financial reporting occurred during the three months ended June 30, 2025[166](index=166&type=chunk) PART II — OTHER INFORMATION [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not currently involved in any material legal proceedings[169](index=169&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors were reported, except for an update on international trade disputes - No material changes to risk factors from the 2024 Annual Report on Form 10-K, except for an update on international trade disputes[170](index=170&type=chunk) - Changes in U.S. trade policy, including new or increased tariffs, could raise material or component costs, reducing margins or impacting product affordability[171](index=171&type=chunk) - Retaliatory tariffs could delay supplies and adversely affect international market operations or growth[171](index=171&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable for the reporting period - Not applicable[172](index=172&type=chunk) [Item 3. Defaults Upon Senior Securities](index=34&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable for the reporting period - Not applicable[174](index=174&type=chunk) [Item 4. Mine Safety Disclosures](index=34&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable for the reporting period - Not applicable[175](index=175&type=chunk) [Item 5. Other Information](index=34&type=section&id=Item%205.%20Other%20Information) No Rule 10b5-1 trading arrangements were adopted, modified, or terminated by officers or directors - No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted, modified, or terminated by officers or directors during the three and six months ended June 30, 2025[176](index=176&type=chunk) [Item 6. Exhibits](index=35&type=section&id=Item%206.%20Exhibits) Lists the exhibits filed with the report, including officer certifications and XBRL documents - Includes Certifications of the Principal Executive Officer and Principal Financial Officer pursuant to Section 302 and Section 906 of the Sarbanes-Oxley Act of 2002[178](index=178&type=chunk) - Contains Inline XBRL Instance Document, Taxonomy Extension Schema Document, and Cover Page Interactive Data File[178](index=178&type=chunk) Signatures [Authorized Signatories](index=36&type=section&id=Authorized%20Signatories) The report was duly signed by the President and CEO, and the CAO and CFO on August 13, 2025 - The report was signed by Maria Sainz (President and CEO) and Brett Hale (CAO, CFO, Treasurer, and Corporate Secretary) on August 13, 2025[182](index=182&type=chunk)
Crescent Capital BDC(CCAP) - 2025 Q2 - Quarterly Results
2025-08-13 20:15
[Crescent Capital BDC, Inc. Q2 2025 Earnings Release](index=1&type=section&id=Crescent%20Capital%20BDC%2C%20Inc.%20Q2%202025%20Earnings%20Release) [Financial and Operational Highlights](index=1&type=section&id=Financial%20and%20Operational%20Highlights) Crescent BDC reported Q2 2025 net investment income of **$0.46 per share** and **NAV of $19.55 per share**, declared a **$0.42 dividend**, and authorized a **$20 million stock repurchase program** Q2 2025 Key Per-Share Metrics | Metric | Value ($ per Share) | | :--- | :--- | | Net Investment Income | $0.46 | | Net Income | $0.41 | | Net Asset Value (NAV) | $19.55 | - The Board of Directors declared a third-quarter 2025 regular cash dividend of **$0.42 per share**[3](index=3&type=chunk) - A new stock repurchase program was authorized to buy back up to **$20.0 million** of common stock when trading below NAV[4](index=4&type=chunk) Quarterly Financial Trends | Metric | June 30, 2025 | March 31, 2025 | June 30, 2024 | | :--- | :--- | :--- | :--- | | Net asset value per share | $19.55 | $19.62 | $20.30 | | Net investment income per share | $0.46 | $0.45 | $0.59 | | Investments, at fair value | $1,600.7M | $1,620.7M | $1,610.8M | [Portfolio and Investment Activity](index=1&type=section&id=Portfolio%20and%20Investment%20Activity) The company's Q2 2025 portfolio fair value was **$1.6 billion**, primarily first lien debt, with net investment outflows Portfolio Composition by Asset Type (June 30, 2025) | Investment Type | Fair Value ($M) | Percentage | | :--- | :--- | :--- | | Senior secured first lien | $381.3 | 23.8% | | Unitranche first lien | $1,043.6 | 65.2% | | Unitranche first lien - last out | $26.2 | 1.6% | | Senior secured second lien | $23.4 | 1.5% | | Other (Unsecured, Equity, etc.) | $126.2 | 7.9% | | **Total investments** | **$1,600.7** | **100.0%** | Q2 2025 Investment Activity | Activity | Amount ($M) | | :--- | :--- | | New Investments & Fundings | $57.5 | | Exits, Sales & Repayments | $92.7 | [Results of Operations](index=2&type=section&id=Results%20of%20Operations) Q2 2025 total investment income increased to **$43.0 million** sequentially, driven by higher dividend income, with total net expenses also rising Investment Income Comparison (QoQ) | Income Type | Q2 2025 ($M) | Q1 2025 ($M) | | :--- | :--- | :--- | | Interest Income | $40.1 | $39.7 | | Dividend Income | $1.8 | $1.5 | | Other Income | $1.0 | $0.9 | | **Total Investment Income** | **$43.0** | **$42.1** | - Total net expenses for the three months ended June 30, 2025, were **$26.1 million**, compared to **$25.5 million** for the quarter ended March 31, 2025[9](index=9&type=chunk) [Liquidity and Capital Resources](index=2&type=section&id=Liquidity%20and%20Capital%20Resources) Crescent BDC maintained **$26.1 million** in cash and **$227.2 million** undrawn credit capacity, with a stable **1.23x** debt-to-equity ratio Liquidity and Leverage (June 30, 2025) | Metric | Value | | :--- | :--- | | Cash and Cash Equivalents | $26.1 million | | Undrawn Credit Facility Capacity | $227.2 million | | Weighted Average Cost of Debt | 6.09% | | Debt to Equity Ratio | 1.23x | [Consolidated Financial Statements](index=6&type=section&id=Consolidated%20Financial%20Statements) Consolidated financial statements show total net assets of **$724.7 million** and Q2 net investment income of **$16.9 million** [Consolidated Statements of Assets and Liabilities](index=6&type=section&id=Consolidated%20Statements%20of%20Assets%20and%20Liabilities) The balance sheet shows total assets of **$1.65 billion** and total liabilities of **$929.7 million**, with total net assets at **$724.7 million** Balance Sheet Summary (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total Assets | $1,654,444 | $1,656,274 | | Total Liabilities | $929,728 | $915,637 | | **Total Net Assets** | **$724,716** | **$740,637** | [Consolidated Statements of Operations](index=7&type=section&id=Consolidated%20Statements%20of%20Operations) Q2 2025 operations generated **$43.0 million** in total investment income and **$16.9 million** in net investment income, with a **$15.0 million** net increase in net assets Income Statement Summary (Three Months Ended June 30, in thousands) | Account | 2025 | 2024 | | :--- | :--- | :--- | | Total Investment Income | $42,992 | $48,951 | | Net Expenses | $25,705 | $26,815 | | **Net Investment Income** | **$16,887** | **$21,703** | | Net Realized/Unrealized Losses | $(1,874) | $(1,499) | | **Net Increase in Net Assets** | **$15,013** | **$20,385** | [Corporate Information and Events](index=2&type=section&id=Corporate%20Information%20and%20Events) Crescent BDC will host a conference call on August 14, 2025, to discuss Q2 results, managed by Crescent Capital Group with **$47 billion** in AUM - The company will host a conference call and webcast on Thursday, August 14, 2025, at 12:00 p.m. (Eastern Time) to discuss the quarterly results[11](index=11&type=chunk) - Crescent BDC is externally managed by Crescent Cap Advisors, LLC, a subsidiary of Crescent Capital Group, which has **$47 billion** of assets under management[18](index=18&type=chunk)[19](index=19&type=chunk)
BEST SPAC I Acquisition Corp Unit(BSAAU) - 2025 Q2 - Quarterly Report
2025-08-13 20:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (MARK ONE) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarter ended June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-42700 BEST SPAC I ACQUISITION CORP. (Exact Name of Registrant as Specified in Its Charter) British Virgin Islands N/A (State or other jurisd ...
Enliven Therapeutics(ELVN) - 2025 Q2 - Quarterly Results
2025-08-13 20:15
Exhibit 99.1 Enliven Therapeutics Reports Second Quarter Financial Results and Provides a Business Update Announced positive data from the Phase 1 clinical trial of ELVN-001 in CML, reporting a cumulative MMR rate of 47% with 32% of patients achieving MMR by 24 weeks and demonstrating a favorable safety and tolerability profile across all dose levels Strong balance sheet with $491 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into the first half of 202 ...
IMARA(IMRA) - 2025 Q2 - Quarterly Results
2025-08-13 20:15
Exhibit 99.1 Enliven Therapeutics Reports Second Quarter Financial Results and Provides a Business Update Announced positive data from the Phase 1 clinical trial of ELVN-001 in CML, reporting a cumulative MMR rate of 47% with 32% of patients achieving MMR by 24 weeks and demonstrating a favorable safety and tolerability profile across all dose levels Strong balance sheet with $491 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into the first half of 202 ...
Aethlon Medical(AEMD) - 2026 Q1 - Quarterly Results
2025-08-13 20:15
[Corporate and Financial Highlights](index=1&type=section&id=Corporate%20and%20Financial%20Highlights) Aethlon Medical advanced its Australian cancer trial, published promising preclinical data, and significantly reduced operating expenses in Q1 FY2025 [Key First Quarter Highlights](index=1&type=section&id=Key%20First%20Quarter%20Highlights) In the first quarter of fiscal 2025, Aethlon Medical made significant progress in its Australian Hemopurifier® cancer trial, completing the first cohort without serious adverse events and amending the protocol to widen patient eligibility. The company also published promising preclinical data showing high efficacy in removing extracellular vesicles (EVs) and advanced its Long COVID research. Operationally, Aethlon achieved a 31.6% reduction in operating expenses, improving financial efficiency - The first patient cohort in the Australian Hemopurifier® cancer trial was completed without any device-related serious adverse events or dose-limiting toxicities observed[3](index=3&type=chunk)[5](index=5&type=chunk) - The trial protocol was amended to include patients receiving anti-PD-1 agents in combination therapies, broadening the potential patient pool[3](index=3&type=chunk)[8](index=8&type=chunk) - Preclinical data demonstrated a **98.5% removal** of platelet-derived extracellular vesicles (EVs) in a simulated 4-hour treatment, supporting the device's mechanism of action[3](index=3&type=chunk)[13](index=13&type=chunk) - Operating expenses were reduced by **31.6%** compared to the same period in the prior year, enhancing operational efficiency[3](index=3&type=chunk)[19](index=19&type=chunk) [Clinical and Preclinical Development](index=1&type=section&id=Clinical%20and%20Preclinical%20Development) Aethlon progressed its Australian oncology trial, discontinued the India trial, and demonstrated Hemopurifier efficacy in preclinical and Long COVID research [Australian Oncology Trial Update](index=1&type=section&id=Australian%20Oncology%20Trial%20Update) The Australian oncology trial evaluating the Hemopurifier in patients with solid tumors unresponsive to anti-PD-1 therapy has successfully completed its first cohort. All participants tolerated the treatment well, with no device-related serious adverse events. Following a positive review by the Data Safety Monitoring Board (DSMB), the trial is advancing to a second cohort where patients will receive two treatments. The protocol has been expanded to increase patient eligibility, and initial findings on the device's effect on T-cell activity are expected in September 2025 - The first treatment cohort was completed without device-related deficiencies, immediate complications, or dose-limiting toxicities[5](index=5&type=chunk) - The independent DSMB reviewed the safety data and recommended advancing to the second treatment cohort, which will involve two Hemopurifier treatments per participant within one week[6](index=6&type=chunk) - The trial protocol was amended to expand eligibility to patients receiving either monotherapy or combination therapy that includes Pembrolizumab or Nivolumab, reflecting current care standards[8](index=8&type=chunk) - The primary endpoint of the trial is safety, with exploratory objectives to assess the reduction of extracellular vesicles (EVs) to inform the design of a future Premarket Approval (PMA) study[10](index=10&type=chunk) [India Oncology Trial Update](index=2&type=section&id=India%20Oncology%20Trial%20Update) Aethlon has decided to discontinue its planned oncology trial in India. This strategic decision was made after discussions with its CRO indicated that the first patient treatment would likely be delayed until early 2026. The company will instead focus its resources on the ongoing Australian trial to generate more timely clinical data - Despite receiving approval from India's Central Drugs Standard Control Organization (CDSCO), the company will not proceed with the planned oncology trial at Medanta Medicity Hospital[12](index=12&type=chunk) - The decision was driven by an extended timeline projecting the first patient treatment in early 2026, associated costs, and a strategic focus on the Australian trial for generating timely data to support a potential PMA trial[12](index=12&type=chunk) [Preclinical Study and Broader Applications](index=2&type=section&id=Preclinical%20Study%20and%20Broader%20Applications) A preclinical ex vivo study, published in bioRxiv, demonstrated that the Hemopurifier effectively removed 98.5% of platelet-derived extracellular vesicles (PD-EVs) from human plasma. As elevated PD-EVs are associated with numerous diseases including cancer, lupus, and Alzheimer's, these findings support the scientific basis for the current oncology trial and suggest broader potential therapeutic applications for the Hemopurifier - A preclinical study showed the Hemopurifier removed **98.5%** of platelet-derived extracellular vesicles (PD-EVs) from healthy human plasma during a simulated 4-hour treatment[13](index=13&type=chunk) - The findings support the rationale for the Australian oncology trial and suggest broader potential applications for the Hemopurifier in other EV-associated diseases such as lupus, multiple sclerosis, Alzheimer's disease, and Long COVID[13](index=13&type=chunk) [Long COVID Research Collaboration](index=2&type=section&id=Long%20COVID%20Research%20Collaboration) Aethlon presented findings from its collaboration with UCSF at the Keystone Symposium on Long COVID. The research demonstrated that extracellular vesicles (EVs) from Long COVID patients bind to the Hemopurifier's proprietary GNA lectin affinity resin. This supports the hypothesis that the device could be a potential treatment for Long COVID, a condition with a significant unmet medical need - In collaboration with UCSF, Aethlon presented research at the Keystone Symposium on Long COVID, a condition with no currently available specific treatments[14](index=14&type=chunk) - Data showed that both large and small EVs from Long COVID patients bind to the Hemopurifier's lectin affinity resin, supporting the device's potential utility for these individuals[16](index=16&type=chunk) [Financial Results](index=3&type=section&id=Financial%20Results) Aethlon reported a reduced net loss in Q1 FY2025, driven by a 31.6% decrease in operating expenses, with a cash balance of $3.8 million [Financial Performance for Q1 FY2025](index=3&type=section&id=Financial%20Performance%20for%20Q1%20FY2025) For the first quarter ended June 30, 2025, Aethlon reported a cash balance of $3.8 million. The company significantly reduced its operating expenses by 31.6% to $1.8 million, down from $2.6 million in the prior-year quarter. This was primarily due to lower payroll, professional fees, and G&A costs. Consequently, the operating loss narrowed to $1.8 million from $2.6 million, and the net loss per share improved to ($0.85) from ($2.76) - As of June 30, 2025, the company had a cash balance of approximately **$3.8 million**[18](index=18&type=chunk) Operating Expense Comparison (Q1 FY2025 vs Q1 FY2024) | Expense Category | Q1 FY2025 (ended Jun 30, 2025) | Q1 FY2024 (ended Jun 30, 2024) | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | **Total Operating Expenses** | **$1,792,390** | **$2,620,858** | **($828,468)** | **-31.6%** | | Payroll and related expenses | $581,000 | $1,254,802 | ($673,802) | -53.7% | | Professional fees | $476,032 | $614,082 | ($138,050) | -22.5% | | General and administrative | $735,358 | $751,974 | ($16,616) | -2.2% | - The decrease in payroll expenses was mainly due to the absence of a **$321,000** severance expense recorded in the prior year and a **$286,000** reduction in compensation costs from lower headcount[20](index=20&type=chunk) Net Loss and EPS Comparison (Q1 FY2025 vs Q1 FY2024) | Metric | Q1 FY2025 (ended Jun 30, 2025) | Q1 FY2024 (ended Jun 30, 2024) | | :--- | :--- | :--- | | **Operating Loss** | **($1,792,390)** | **($2,620,858)** | | **Net Loss** | **($1,761,858)** | **($2,571,440)** | | **Net Loss Per Share** | **($0.85)** | **($2.76)** | [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Aethlon's balance sheet showed total assets of $5.3 million, a decrease from $7.4 million on March 31, 2025. The decline was primarily driven by a reduction in cash and cash equivalents. Total liabilities decreased to $1.9 million from $2.2 million, while total stockholders' equity stood at $3.4 million, down from $5.1 million at the end of the previous fiscal year Balance Sheet Summary | Account | June 30, 2025 | March 31, 2025 | | :--- | :--- | :--- | | **Total Assets** | **$5,306,002** | **$7,359,534** | | Cash and cash equivalents | $3,765,154 | $5,501,261 | | Total Current Assets | $4,050,858 | $5,949,800 | | **Total Liabilities** | **$1,882,489** | **$2,236,004** | | Total Current Liabilities | $1,627,437 | $1,899,286 | | **Total Stockholders' Equity** | **$3,423,513** | **$5,123,530** | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended June 30, 2025, Aethlon reported a net loss of $1.76 million, or ($0.85) per share. This represents a significant improvement compared to a net loss of $2.57 million, or ($2.76) per share, for the same period in 2024. The reduced loss was primarily due to a 31.6% decrease in total operating expenses Statement of Operations Summary | Account | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Total operating expenses | $1,792,390 | $2,620,858 | | **Operating Loss** | **($1,792,390)** | **($2,620,858)** | | Net Loss | ($1,761,858) | ($2,571,440) | | **Basic and diluted net loss per share** | **($0.85)** | **($2.76)** | | Weighted average shares outstanding | 2,076,416 | 932,248 | [Company and Product Overview](index=4&type=section&id=Company%20and%20Product%20Overview) The Hemopurifier is an investigational medical device with U.S. FDA Breakthrough Device Designation for cancer and life-threatening viral treatments [About the Hemopurifier®](index=4&type=section&id=About%20the%20Hemopurifier%C2%AE) The Aethlon Hemopurifier® is an investigational medical device that operates outside the body to remove harmful enveloped viruses and tumor-derived extracellular vesicles (EVs) from the blood. It has been granted Breakthrough Device Designation by the U.S. FDA for two key indications: the treatment of advanced or metastatic cancer patients who are unresponsive to standard care, and for life-threatening viruses that lack approved therapies - The Hemopurifier is an investigational medical device designed for the extracorporeal removal of enveloped viruses and tumor-derived extracellular vesicles (EVs) from circulation[29](index=29&type=chunk) - It holds a U.S. FDA Breakthrough Device Designation for treating individuals with advanced or metastatic cancer unresponsive to standard therapy, and for treating life-threatening viruses without approved therapies[30](index=30&type=chunk)
Acrivon Therapeutics(ACRV) - 2025 Q2 - Quarterly Results
2025-08-13 20:15
[Business Highlights](index=1&type=section&id=Business%20Highlights) Acrivon advances clinical assets ACR-368 and ACR-2316, showcasing the AP3 platform's role in drug development and initial clinical activity [ACR-368: CHK1 and CHK2 Inhibitor](index=1&type=section&id=ACR-368%3A%20CHK1%20and%20CHK2%20Inhibitor) The registrational-intent Phase 2b trial for ACR-368 in endometrial cancer is ongoing, with a new arm evaluating combination therapy for broader patient access - The company is continuing to advance its registrational-intent, multicenter Phase 2b trial of ACR-368 in patients with recurrent high-grade endometrial cancer who have failed prior platinum-based chemotherapy and immune checkpoint inhibitor treatments[3](index=3&type=chunk)[4](index=4&type=chunk) - A third arm has been initiated in the Phase 2b study to evaluate ACR-368 with ultra low-dose gemcitabine (ULDG) in all-comer, biomarker-unselected 2nd line endometrial cancer patients, which does not require a pre-treatment biopsy[4](index=4&type=chunk) - Clinical data has shown deep and durable responses in patients with aggressive endometrial cancer who had progressed on prior chemotherapy and anti-PD1 therapy[2](index=2&type=chunk) [ACR-2316: WEE1/PKMYT1 Inhibitor](index=2&type=section&id=ACR-2316%3A%20WEE1%2FPKMYT1%20Inhibitor) The Phase 1 dose-escalation trial for ACR-2316 is enrolling patients, showing no dose-limiting toxicities, target engagement, and early clinical activity - The Phase 1 monotherapy dose-escalation trial is enrolling patients with high unmet need solid tumor types, prioritized based on AP3-predicted sensitivity[9](index=9&type=chunk) - Key early findings from the Phase 1 trial include: - No dose-limiting toxicities observed in three cleared dose levels - Evidence of drug target engagement observed as early as dose level 1 - Initial clinical activity seen, including an ongoing confirmed partial response in endometrial cancer[9](index=9&type=chunk)[2](index=2&type=chunk) [Generative Phosphoproteomics AP3 Platform](index=1&type=section&id=Generative%20Phosphoproteomics%20AP3%20Platform) The AI-driven AP3 platform accelerates novel compound design and development, demonstrating its ability to uncover key molecular mechanisms - The AI-driven AP3 platform enables a new paradigm for accelerated design and development of novel compounds by providing optimal intracellular pathway selectivity[1](index=1&type=chunk) - At the AACR Annual Meeting in April 2025, the company presented AP3 analyses that uncovered key molecular mechanisms by which ACR-2316 induces strong, pro-apoptotic tumor cell death[5](index=5&type=chunk) [Future Outlook](index=2&type=section&id=Future%20Outlook) Acrivon anticipates providing updates on ACR-368 and ACR-2316 clinical data in H2 2025, alongside advancing a new cell cycle drug discovery program - Key anticipated milestones for the remainder of 2025 include: - An update on the registrational-intent trial and confirmatory trial design for ACR-368 in H2 2025 - A report of initial clinical data from the Phase 1 clinical study of ACR-2316 in H2 2025 - Advancement of a new cell cycle drug discovery program towards development candidate nomination[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Results) Acrivon reported a **$21.0 million net loss** in Q2 2025, driven by R&D, with **$147.6 million cash** funding operations into Q2 2027 [Summary of Operations](index=2&type=section&id=Summary%20of%20Operations) Q2 2025 net loss increased to **$21.0 million** from **$18.8 million** in Q2 2024, primarily due to higher R&D Statement of Operations (Three Months Ended June 30, in thousands) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | | :--- | :--- | :--- | | Net Loss | ($21,006) | ($18,798) | | R&D Expenses | $16,182 | $15,025 | | G&A Expenses | $6,467 | $6,412 | - The increase in R&D expenses was primarily due to increased personnel to support the clinical trials for ACR-368 and ACR-2316, as well as preclinical drug discovery[7](index=7&type=chunk) [Financial Position and Runway](index=1&type=section&id=Financial%20Position%20and%20Runway) Acrivon's cash, cash equivalents, and marketable securities totaled **$147.6 million** as of June 30, 2025, providing funding into Q2 2027 - Cash, cash equivalents and marketable securities totaled **$147.6 million** as of June 30, 2025[1](index=1&type=chunk)[8](index=8&type=chunk) - The company's cash position is expected to fund operations into the second quarter of 2027[1](index=1&type=chunk)[8](index=8&type=chunk) [Company Overview](index=3&type=section&id=Company%20Overview) Acrivon is a clinical-stage biopharmaceutical company leveraging its AI-driven AP3 platform to develop precision medicines, including lead programs ACR-368 and ACR-2316 - Acrivon uses its proprietary Generative Phosphoproteomics AP3 platform to interpret and quantify drug-regulated pathway activity, enabling the design of differentiated compounds[10](index=10&type=chunk) - The lead program, ACR-368 (a CHK1/CHK2 inhibitor), is in a potentially registrational Phase 2 trial for endometrial cancer and has received FDA Fast Track designation[11](index=11&type=chunk) - The second clinical asset, ACR-2316 (a WEE1/PKMYT1 inhibitor), is advancing in a Phase 1 trial and has shown initial clinical activity and drug target engagement[12](index=12&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) The financial statements detail a **$21.0 million net loss** for Q2 2025 and total assets of **$158.6 million** as of June 30, 2025, reflecting a decrease from year-end 2024 [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Acrivon reported a **$21.0 million net loss** for Q2 2025, or **($0.55) per share**, compared to a **$18.8 million net loss** in Q2 2024 Statement of Operations (Three Months Ended June 30, in thousands) | | 2025 (in thousands) | 2024 (in thousands) | | :--- | :--- | :--- | | Research and development | $16,182 | $15,025 | | General and administrative | $6,467 | $6,412 | | **Total operating expenses** | **$22,649** | **$21,437** | | Loss from operations | ($22,649) | ($21,437) | | Total other income, net | $1,643 | $2,639 | | **Net loss** | **($21,006)** | **($18,798)** | | Net loss per share | ($0.55) | ($0.52) | [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets were **$158.6 million**, a decrease from **$196.6 million** at year-end 2024, with total liabilities at **$15.5 million** Balance Sheet Summary (in thousands) | | June 30, 2025 (in thousands) | Dec 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $41,895 | $39,818 | | Investments | $105,727 | $144,751 | | **Total assets** | **$158,583** | **$196,588** | | Total Liabilities | $15,546 | $19,802 | | Total Stockholders' Equity | $143,037 | $176,786 |
Eyenovia(EYEN) - 2025 Q2 - Quarterly Results
2025-08-13 20:15
Exhibit 99.1 Hyperion DeFi Provides Corporate Update and Reports Second Quarter 2025 Financial Results Successfully establishes cryptocurrency treasury reserve focused on the HYPE token and becomes the first publicly listed U.S. company to implement DeFi strategies on Hyperliquid blockchain Accumulates more than 1.5 million HYPE to date and establishes co-branded validator with Kinetiq Reiterates FDA registration of the Optejet User Filled Device (UFD) remains on track for September 2025 LAGUNA HILLS, CA—Au ...