Galectin Therapeutics(GALT) - 2025 Q2 - Quarterly Report
2025-08-14 11:53
[PART I — FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) [ITEM 1. Unaudited Condensed Consolidated Financial Statements](index=3&type=section&id=ITEM%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section presents Galectin Therapeutics Inc.'s unaudited condensed consolidated financial statements for Q2 2025, detailing balance sheets, operations, cash flows, and stockholders' deficit, with notes on accounting policies and financial instruments [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a decrease in total assets and an increase in total liabilities from December 31, 2024, to June 30, 2025, primarily driven by changes in convertible notes payable and derivative liabilities, leading to an increased stockholders' deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | % Change | | :------------------------------------- | :------------ | :---------------- | :----- | :------- | | Cash and cash equivalents | $13,771 | $15,120 | $(1,349) | -8.92% | | Total current assets | $15,427 | $17,252 | $(1,825) | -10.58% | | Total assets | $15,602 | $17,495 | $(1,893) | -10.82% | | Total current liabilities | $10,774 | $35,409 | $(24,635)| -69.57% | | Total liabilities | $132,769 | $120,565 | $12,204 | 10.12% | | Total stockholders' deficit | $(118,890) | $(104,793) | $(14,097)| 13.45% | - Convertible notes payable and accrued interest (non-current) increased significantly from **$10,733,000** at December 31, 2024, to **$32,308,000** at June 30, 2025[7](index=7&type=chunk) - Borrowing and accrued interest under convertible lines of credit (related party) increased from **$74,376,000** to **$88,150,000**[7](index=7&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a reduced net loss for both the three and six months ended June 30, 2025, compared to the same periods in 2024, primarily due to a significant decrease in research and development expenses, despite an increase in interest expense and change in fair value of derivative liabilities Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $3,261 | $9,813 | $9,746 | $17,867 | | General and administrative | $1,364 | $1,478 | $2,776 | $3,072 | | Total operating expenses | $4,625 | $11,291 | $12,522 | $20,939 | | Total operating loss | $(4,625) | $(11,291) | $(12,522) | $(20,939) | | Interest expense | $(1,826) | $(1,269) | $(3,570) | $(2,321) | | Change in fair value of derivative | $(1,096) | $109 | $(1,121) | $(760) | | Net loss | $(7,521) | $(12,371) | $(17,152) | $(23,860) | | Net loss per common share | $(0.12) | $(0.20) | $(0.27) | $(0.39) | - Research and development expenses decreased by **67%** for the three months ended June 30, 2025, and by **45%** for the six months ended June 30, 2025, compared to the prior year periods[9](index=9&type=chunk) - Net loss applicable to common stockholders decreased from **$(12,435,000)** to **$(7,584,000)** for the three months ended June 30, 2025, and from **$(23,932,000)** to **$(17,189,000)** for the six months ended June 30, 2025[9](index=9&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly decreased for the six months ended June 30, 2025, compared to the same period in 2024, primarily due to lower net loss and adjustments for non-cash items. However, net cash flows from financing activities also decreased, leading to a larger net decrease in cash and cash equivalents Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | | Net loss | $(17,152) | $(23,860) | | Net cash from operating activities | $(14,291) | $(20,438) | | Net cash flows from financing activities | $12,942 | $20,376 | | NET DECREASE IN CASH AND CASH EQUIVALENTS | $(1,349) | $(62) | | CASH AND CASH EQUIVALENTS, END OF PERIOD | $13,771 | $25,598 | - Net cash used in operating activities decreased by **$6,147,000**, from **$(20,438,000)** in 2024 to **$(14,291,000)** in 2025[11](index=11&type=chunk) - Net cash flows from financing activities decreased by **$7,434,000**, from **$20,376,000** in 2024 to **$12,942,000** in 2025, primarily due to decreased borrowings under related party lines of credit[11](index=11&type=chunk)[160](index=160&type=chunk) [Condensed Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders' Deficit](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Redeemable%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Deficit) The statements detail changes in preferred stock and stockholders' deficit, reflecting net losses, preferred stock dividends, common stock issuances from option/warrant exercises, and conversions, leading to an increased accumulated deficit - Total stockholders' deficit increased from **$(104,793,000)** at December 31, 2024, to **$(118,890,000)** at June 30, 2025[7](index=7&type=chunk)[16](index=16&type=chunk) - Common stock outstanding increased from **63,157,235** shares at December 31, 2024, to **64,060,262** shares at June 30, 2025[7](index=7&type=chunk)[16](index=16&type=chunk) - Additional paid-in capital increased from **$296,217,000** to **$299,318,000**, while retained deficit increased from **$(401,572,000)** to **$(418,761,000)** due to net losses and preferred stock dividends[7](index=7&type=chunk)[16](index=16&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide critical context to the financial statements, detailing the company's business, liquidity challenges, related-party debt, fair value measurements, stock-based compensation, and clinical development activities, highlighting the going concern uncertainty and reliance on future financing [1. Basis of Presentation and Liquidity](index=10&type=section&id=1.%20Basis%20of%20Presentation%20and%20Liquidity) Galectin Therapeutics Inc. is a clinical-stage biopharmaceutical company facing going concern uncertainty due to historical losses and no revenue, despite having $13.8 million cash and a new $10 million credit line to fund operations through June 2026 - The Company is a clinical stage biopharmaceutical company developing therapies for fibrotic disease and cancer by targeting galectin proteins[17](index=17&type=chunk) - The Company has operated at a loss since its inception and has had no revenues, anticipating continued losses[20](index=20&type=chunk) Liquidity Position (in thousands) | Metric | June 30, 2025 | | :-------------------------------- | :------------ | | Unrestricted cash and cash equivalents | $13,771 | | New line of credit (July 8, 2025) | $10,000 | - The Company believes it has sufficient cash, including the new line of credit, to fund planned operations through **June 30, 2026**, but needs to raise additional capital thereafter[20](index=20&type=chunk) [2. Accrued Expenses and Other](index=10&type=section&id=2.%20Accrued%20Expenses%20and%20Other) Accrued expenses decreased significantly from December 31, 2024, to June 30, 2025, primarily due to a reduction in accrued research and development costs and accrued compensation. The company accrues clinical trial expenses based on estimated work completed by CROs Accrued Expenses (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Legal and accounting fees | $71 | $74 | | Accrued compensation | $844 | $1,523 | | Lease liability | $52 | $19 | | Accrued research and development costs | $3,879 | $6,588 | | Total | $4,846 | $8,204 | - Accrued research and development costs decreased by **$2,709,000**, from **$6,588,000** to **$3,879,000**[22](index=22&type=chunk) - Accrued compensation decreased by **$679,000**, from **$1,523,000** to **$844,000**[22](index=22&type=chunk) [3. Convertible Notes Payable – Related Party](index=12&type=section&id=3.%20Convertible%20Notes%20Payable%20%E2%80%93%20Related%20Party) The company has three convertible promissory notes totaling $30 million from a related party (Richard E. Uihlein), all of which had their maturity dates extended to September 30, 2026. These notes bear 2% annual interest and include a contingent interest component recognized as a derivative liability, which has seen significant fair value changes - Three convertible promissory notes (April 2021, September 2021, December 2021), each for **$10,000,000**, were issued by Richard E. Uihlein[24](index=24&type=chunk)[28](index=28&type=chunk)[30](index=30&type=chunk) - All three notes' maturity dates were extended to **September 30, 2026**, in connection with the July 2025 Supplemental Line of Credit[27](index=27&type=chunk)[28](index=28&type=chunk)[30](index=30&type=chunk)[103](index=103&type=chunk) - Contingent interest components of these notes are bifurcated and recognized as derivative liabilities, with fair values increasing significantly from December 31, 2024, to June 30, 2025[26](index=26&type=chunk)[29](index=29&type=chunk)[31](index=31&type=chunk)[34](index=34&type=chunk) [4. Fair Value of Financial Instruments](index=13&type=section&id=4.%20Fair%20Value%20of%20Financial%20Instruments) The company's Level 3 derivative liabilities, primarily contingent interest on convertible notes, increased substantially from December 31, 2024, to June 30, 2025. These are valued using a Monte Carlo Geometric Brownian Stock Path Model, with key assumptions including stock price, term, risk-free rate, credit-adjusted discount rate, and volatility Level 3 Derivative Liabilities (in thousands) | Derivative Liability | June 30, 2025 | December 31, 2024 | | :------------------------------------- | :------------ | :---------------- | | Contingent Interest April Note | $650 | $47 | | Contingent Interest September Note | $298 | $94 | | Contingent Interest December Note | $589 | $275 | | Total | $1,537 | $416 | - The fair value adjustment for the April Note derivative liability was **$603,000** for the six months ended June 30, 2025[35](index=35&type=chunk) - Key valuation assumptions for derivatives include a stock price of **$2.11** at June 30, 2025 (up from **$1.29** at Dec 31, 2024) and volatility ranging from **101%** to **102%**[35](index=35&type=chunk) [5. Stock-Based Compensation](index=16&type=section&id=5.%20Stock-Based%20Compensation) Total stock-based compensation expense decreased for both the three and six months ended June 30, 2025, compared to 2024. Stock option activity included significant grants and exercises, while restricted stock units were issued to employees with vesting tied to a partnership or year-end Stock-Based Compensation Expense (in thousands) | Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $254 | $386 | $530 | $709 | | General and administrative | $246 | $352 | $436 | $633 | | Total stock-based compensation expense | $500 | $738 | $966 | $1,342 | - **1,211,000** stock options were granted during the six months ended June 30, 2025, with a weighted-average grant date fair value of **$0.87**[37](index=37&type=chunk) - **504,000** restricted stock units valued at **$620,000** were issued to employees during the six months ended June 30, 2025, vesting on the earlier of a partnership or December 31, 2025[40](index=40&type=chunk) [6. Common Stock Warrants](index=18&type=section&id=6.%20Common%20Stock%20Warrants) The number of common stock warrants outstanding increased slightly from December 31, 2024, to June 30, 2025, with new grants and some forfeitures. The weighted average exercise price remained stable Common Stock Warrant Activity | Metric | Shares | Weighted Average Exercise Price | | :-------------------------- | :------- | :------------------------------ | | Outstanding, Dec 31, 2024 | 9,595,940| $4.22 | | Granted | 220,000 | $3.00 | | Forfeited/cancelled | (111,510)| $3.00 | | Outstanding, June 30, 2025 | 9,704,430| $4.20 | - The weighted average expiration of warrants outstanding as of June 30, 2025, is **1.6 years**[46](index=46&type=chunk) [7. Loss Per Share](index=18&type=section&id=7.%20Loss%20Per%20Share) Basic and diluted net loss per common share decreased for the six months ended June 30, 2025, compared to 2024. A significant number of potential common shares from warrants, options, convertible notes, and preferred stock were anti-dilutive and thus excluded from diluted EPS calculation Net Loss Per Common Share | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | | Net loss per common share — basic and diluted | $(0.27) | $(0.39) | Anti-Dilutive Shares (shares) | Instrument | June 30, 2025 | June 30, 2024 | | :------------------------------------------------ | :------------ | :------------ | | Warrants to purchase shares of common stock | 9,704,430 | 9,426,853 | | Options to purchase shares of common stock | 7,541,818 | 7,369,758 | | Restricted stock units | 496,520 | 408,000 | | Shares from convertible notes payable – related party | 7,327,374 | 6,721,188 | | Shares from convertible line of credit – related party | 29,621,834 | 21,016,837 | | Shares from preferred stock conversion | 495,007 | 499,174 | | Total Anti-Dilutive Shares | 55,186,983 | 45,441,810 | [8. Common Stock](index=18&type=section&id=8.%20Common%20Stock) The company issued 419,904 shares of common stock under its At Market Issuance Sales Agreement for net proceeds of $1,218,000 during the quarter ended June 30, 2025. Additionally, shares were issued for preferred stock dividends and conversions - **419,904** shares of common stock were issued under the 2020 At Market Agreement for net proceeds of approximately **$1,218,000** during the quarter ended June 30, 2025[49](index=49&type=chunk) - No shares were issued under the 2020 At Market Agreement during the quarter ended June 30, 2024[49](index=49&type=chunk) - **25,000** shares of Series A Convertible Preferred Stock were converted into **4,167** shares of common stock during the three months ended June 30, 2025[50](index=50&type=chunk) [9. Convertible Line of Credit – Related Party and Supplemental Convertible Lines of Credit – Related Party](index=19&type=section&id=9.%20Convertible%20Line%20of%20Credit%20%E2%80%93%20Related%20Party%20and%20Supplemental%20Convertible%20Lines%20of%20Credit%20%E2%80%93%20Related%20Party) The company has multiple convertible lines of credit from a related party, totaling $81 million, with various draws made and associated warrants issued. All maturity dates for these lines of credit were extended to September 30, 2026. Interest rates vary, and the principal and accrued interest are convertible into common stock at the lender's option - The original Line of Credit (July 2022) provided up to **$60 million**, with its maturity extended to **September 30, 2026**[51](index=51&type=chunk)[52](index=52&type=chunk)[103](index=103&type=chunk) - Several promissory notes were executed under this line, each for **$10 million**, with associated warrants issued to the lender[56](index=56&type=chunk)[58](index=58&type=chunk)[60](index=60&type=chunk)[62](index=62&type=chunk)[64](index=64&type=chunk)[66](index=66&type=chunk) - New supplemental lines of credit were established in March 2024 (**$10M**), November 2024 (**$6M**), and March 2025 (**$5M**), with draws made and warrants issued under each[69](index=69&type=chunk)[76](index=76&type=chunk)[82](index=82&type=chunk) - Accrued interest on these lines of credit increased significantly from December 31, 2024, to June 30, 2025, reflecting ongoing borrowings[56](index=56&type=chunk)[58](index=58&type=chunk)[60](index=60&type=chunk)[62](index=62&type=chunk)[64](index=64&type=chunk)[66](index=66&type=chunk)[73](index=73&type=chunk)[80](index=80&type=chunk) [10. Segments](index=24&type=section&id=10.%20Segments) The company operates as a single segment focused on fibrotic disease therapeutics, with no product revenue. The Chief Executive Officer, as CODM, assesses performance based on net loss, net cash used in operating activities, and cash on hand, using cash forecast models for resource allocation - The Company's operations are viewed as one operating segment, focused on creating new therapies for fibrotic disease based on targeting galectin proteins[89](index=89&type=chunk) - The Company has not generated any product revenue and expects to incur significant expenses and operating losses for the foreseeable future[91](index=91&type=chunk) Segment Operating Results (in thousands) | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | | Total operating expenses | $12,522 | $20,939 | | Total operating loss | $(12,522) | $(20,939) | | Net loss | $(17,152) | $(23,860) | | Net cash used in operating activities | $(14,300) | $(20,400) | [11. Commitments and Contingencies](index=25&type=section&id=11.%20Commitments%20and%20Contingencies) The company has no significant pending legal proceedings and accrues for contingencies when probable and estimable. Clinical trial and research commitments are generally cancellable with 30 days' notice, and the company is negotiating with a contract vendor for clinical trial management services - There are no significant pending legal proceedings[98](index=98&type=chunk) - Agreements with contractors for R&D activities are generally cancellable with **thirty days' notice**[99](index=99&type=chunk) - The Company has accrued its estimate of the amount owed to a contract vendor for clinical trial management services[99](index=99&type=chunk) [12. Leases](index=26&type=section&id=12.%20Leases) The company has one operating lease for office space, renewed in March 2025 for twelve months. The lease liability and right-to-use asset are $52,000 as of June 30, 2025 - The Company renewed its office space lease in March 2025 for **twelve months**, effective March 1, 2022[100](index=100&type=chunk) Operating Lease Maturity (in thousands) | Year | Amount | | :--- | :----- | | 2025 | $33 | | 2026 | $22 | | Total| $55 | | Less imputed interest | $(3) | | Present value of lease liability | $52 | - The discount rate used for lease payments is **14%**[101](index=101&type=chunk) [13. Galectin Sciences LLC](index=26&type=section&id=13.%20Galectin%20Sciences%20LLC) Galectin Therapeutics Inc. co-owns Galectin Sciences LLC, a joint venture for galectin-3 inhibitor research. The company's ownership increased to 85.4% as of June 30, 2025, due to disproportionate funding contributions, and it accounts for the LLC as a consolidated, less than wholly owned subsidiary - Galectin Sciences LLC is a collaborative joint venture co-owned by SBH Sciences, Inc., focused on researching and developing small organic molecule inhibitors of galectin-3[102](index=102&type=chunk) - As of June 30, 2025, the Company's ownership percentage in the LLC was **85.4%**, up from an initial **50%**, due to providing more funding[102](index=102&type=chunk) - The Company has contributed a total of **$4,166,000** to the LLC cumulatively as of June 30, 2025[102](index=102&type=chunk) [14. Subsequent Event](index=26&type=section&id=14.%20Subsequent%20Event) On July 8, 2025, the company secured a new $10 million Supplemental Line of Credit from its chairman, Richard E. Uihlein, extending the maturity dates of all existing convertible notes and lines of credit to September 30, 2026. This new line also includes the issuance of warrants to the lender - On July 8, 2025, the Company entered into a new **$10 million** Supplemental Line of Credit with Richard E. Uihlein[103](index=103&type=chunk) - The maturity dates of all Convertible Notes Payable – Related Party and all borrowings under Convertible Lines of Credit – Related Party were extended to **September 30, 2026**[103](index=103&type=chunk) - In connection with this new line, the Company agreed to issue warrants to purchase up to **200,000** shares of common stock to the lender[106](index=106&type=chunk)[107](index=107&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and operations, focusing on its clinical-stage drug development, particularly belapectin for NASH and cancer, and financial performance for Q2 2025, including R&D, G&A, and liquidity [Overview](index=29&type=section&id=Overview) Galectin Therapeutics is a clinical-stage biopharmaceutical company developing therapies for fibrotic diseases and cancer by targeting galectin proteins, particularly galectin-3. Its lead candidate, belapectin, is in development for NASH cirrhosis (NAVIGATE trial results presented) and cancer immunotherapy (Phase 2 trial planned for head and neck cancer) - The company is a clinical stage biopharmaceutical company focused on developing new therapies for fibrotic disease, cancer, and other conditions by targeting galectin proteins[112](index=112&type=chunk) - Belapectin (GR-MD-02) is the lead galectin-3 inhibitor, demonstrated in preclinical models to reverse liver fibrosis and cirrhosis, and in clinical studies to decrease portal hypertension[113](index=113&type=chunk) - Top-line results from the NAVIGATE Phase 2b/3 clinical trial for NASH cirrhosis showed a **49.3%** reduction in varices incidence in the per-protocol population (p<0.05) and a **68.1%** reduction in U.S. completer patients (p=0.02) for the belapectin **2 mg/kg** dose group[115](index=115&type=chunk)[140](index=140&type=chunk) - A Phase 2 trial for advanced or metastatic head and neck cancer using belapectin in combination with a checkpoint inhibitor is planned, pending financing[121](index=121&type=chunk)[152](index=152&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) Operating expenses decreased significantly for both the three and six months ended June 30, 2025, compared to 2024, primarily driven by a substantial reduction in research and development expenses due to the conclusion of the NAVIGATE clinical trial. General and administrative expenses also saw a modest decrease Operating Expenses (in thousands) | Expense Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | % Change | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | % Change | | :----------------------- | :--------------------------- | :--------------------------- | :------- | :--------------------------- | :--------------------------- | :------- | | Research and development | $3,261 | $9,813 | -67% | $9,746 | $17,867 | -45% | | General and administrative | $1,364 | $1,478 | -8% | $2,776 | $3,072 | -10% | | Total operating expenses | $4,625 | $11,291 | -59% | $12,522 | $20,939 | -40% | - The decrease in research and development expenses is primarily due to lower expenses related to the NAVIGATE clinical trial, which ended in the first quarter of 2025[155](index=155&type=chunk) - General and administrative expenses decreased due to lower stock compensation expense and investor relations/business development expense[158](index=158&type=chunk) [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) The company's cash and cash equivalents stood at $13.8 million as of June 30, 2025, supplemented by a new $10 million line of credit, which is expected to fund operations through June 30, 2026. Net cash used in operations decreased, but cash provided by financing activities also declined, indicating a continued need for future capital Liquidity and Cash Flow (in thousands) | Metric | June 30, 2025 | June 30, 2024 | | :------------------------------------- | :------------ | :------------ | | Cash and cash equivalents | $13,800 | $25,600 | | Net cash used in operations (6 months) | $(14,291) | $(20,438) | | Cash from financing activities (6 months) | $12,942 | $20,376 | - The Company had **$13.8 million** in unrestricted cash and cash equivalents at June 30, 2025, and secured a new **$10 million** line of credit in July 2025[159](index=159&type=chunk) - Management believes current cash and available credit are sufficient to fund operations through **June 30, 2026**, but additional financing will be required thereafter[159](index=159&type=chunk) [Off-Balance Sheet Arrangements](index=39&type=section&id=Off-Balance%20Sheet%20Arrangements) The company has no off-balance sheet arrangements that are reasonably likely to materially affect its liquidity or capital resources - The Company has not created, and is not a party to, any special-purpose or off-balance sheet entities[161](index=161&type=chunk) [Application of Critical Accounting Policies and Estimates](index=39&type=section&id=Application%20of%20Critical%20Accounting%20Policies%20and%20Estimates) The preparation of financial statements requires significant estimates and judgments, particularly concerning accrued expenses, stock-based compensation, and contingencies. Critical accounting policies include stock-based compensation, accrued expenses, and income taxes - Critical accounting policies include stock-based compensation, accrued expenses, and income taxes[163](index=163&type=chunk) - Estimates are based on historical experience, contract terms, industry trends, and other factors, with actual results potentially differing under various assumptions[162](index=162&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures about Market Risk](index=39&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk exposure is to changes in U.S. interest rates. However, due to its short-term investments in operating bank accounts and money market funds, the company believes it is not subject to any material market risk - The primary market risk is the risk of loss due to changes in U.S. interest rates[164](index=164&type=chunk) - The Company maintains its cash and cash equivalents in operating bank accounts and money market funds[164](index=164&type=chunk) - Due to the short-term duration of investments, the Company believes it is not subject to any material market risk exposure[164](index=164&type=chunk) [ITEM 4. Controls and Procedures](index=40&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2025. No material changes in internal control over financial reporting occurred during the quarter - Disclosure controls and procedures were evaluated and deemed effective as of **June 30, 2025**[165](index=165&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[167](index=167&type=chunk) - Management acknowledges that no control system can provide absolute assurance against all errors and fraud[166](index=166&type=chunk) [PART II — OTHER INFORMATION](index=40&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) [ITEM 1. Legal Proceedings](index=40&type=section&id=ITEM%201.%20Legal%20Proceedings) There are no significant pending legal proceedings to report - No significant pending legal proceedings are reported[169](index=169&type=chunk) [ITEM 1A. Risk Factors](index=40&type=section&id=ITEM%201A.%20Risk%20Factors) The company refers readers to the comprehensive list of risk factors detailed in its Annual Report on Form 10-K for the year ended December 31, 2024, which could materially impact its business, financial condition, or future results - Readers are directed to the risk factors in the Annual Report on Form 10-K for the year ended December 31, 2024[170](index=170&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=40&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 - No unregistered sales of equity securities or use of proceeds to report[171](index=171&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=40&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report - No defaults upon senior securities to report[171](index=171&type=chunk) [ITEM 4. Mine Safety Disclosures](index=40&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine Safety Disclosures are not applicable[171](index=171&type=chunk) [ITEM 5. Other Information](index=40&type=section&id=ITEM%205.%20Other%20Information) The company announced its 2025 Annual Meeting of Stockholders will be a virtual meeting on December 3, 2025, and provided updated deadlines for stockholder proposals and nominations. Additionally, all three executive officers adopted Rule 10b5-1 trading arrangements during the quarter - The 2025 Annual Meeting of Stockholders is scheduled for **December 3, 2025**, as a virtual meeting[171](index=171&type=chunk) - Stockholder proposals for inclusion in the proxy statement must be received by **September 1, 2025**[173](index=173&type=chunk) - All three executive officers adopted Rule 10b5-1 trading arrangements during the fiscal quarter ended June 30, 2025[176](index=176&type=chunk) [ITEM 6. Exhibits](index=41&type=section&id=ITEM%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications, XBRL taxonomy documents, and the interactive data file - Exhibits include Certifications Pursuant to Rule 13a-14(a) and 18 U.S.C. Section 1350[177](index=177&type=chunk) - Inline XBRL Instance Document and Taxonomy Extension Documents are also included[177](index=177&type=chunk)[178](index=178&type=chunk) [SIGNATURES](index=43&type=section&id=SIGNATURES) The report is duly signed on behalf of Galectin Therapeutics Inc. by Joel Lewis, Chief Executive Officer and President, and Jack W. Callicutt, Chief Financial Officer, on August 14, 2025 - The report was signed by Joel Lewis, Chief Executive Officer and President, and Jack W. Callicutt, Chief Financial Officer[183](index=183&type=chunk) - The signing date for the report was **August 14, 2025**[182](index=182&type=chunk)
Brainstorm Cell Therapeutics(BCLI) - 2025 Q2 - Quarterly Results
2025-08-14 11:50
Corporate Update and Highlights [Management Commentary](index=1&type=section&id=Management%20Commentary) The CEO highlights FDA clearance for the NurOwn Phase 3b trial as a key milestone and affirms the company's clinical execution focus - Reached a key milestone in Q2 with **FDA clearance** to initiate the Phase 3b trial for NurOwn, designed to support a potential Biologics License Application (BLA) submission[2](index=2&type=chunk) - Advancing operational activities, including discussions with clinical sites and engagement with CDMO partners to ensure readiness for clinical drug supply[2](index=2&type=chunk) - Supports the FDA's consideration of the Citizen Petition, viewing it as a potential opportunity for a fresh, objective evaluation of NurOwn's scientific evidence[2](index=2&type=chunk) [Recent Highlights](index=1&type=section&id=Recent%20Highlights) The company received FDA clearance for its Phase 3b trial, saw a Citizen Petition filed, and reported positive EAP survival data - The FDA has cleared the company to initiate the Phase 3b clinical trial of NurOwn, known as ENDURANCE, expected to enroll **approximately 200 participants**[3](index=3&type=chunk) - A Citizen Petition was submitted to the FDA by the ALS Community, requesting a new review of the NurOwn data, which the company believes provides a new opportunity to reaffirm NurOwn's potential[7](index=7&type=chunk) - New survival data from the NurOwn Expanded Access Program (EAP) showed that **100% of participants (10/10) survived more than 5 years** from the onset of ALS symptoms[7](index=7&type=chunk) - BrainStorm signed a Letter of Intent (LOI) with Minaris Advanced Therapies, a global CDMO, to manufacture NurOwn for the upcoming Phase 3b clinical trial[7](index=7&type=chunk) - New pharmacogenomic data highlighting the impact of the UNC13A genotype on clinical outcomes were selected for presentation at the ISCT 2025 Annual Meeting[7](index=7&type=chunk) Financial Performance [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reported a net loss of $2.9 million for Q2 2025, with increased R&D expenses and decreased G&A expenses Q2 2025 Financial Highlights | Financial Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, and restricted cash | ~$1.03 million | N/A | | Research and development expenditures, net | $1.1 million | $0.9 million | | General and administrative expenses | ~$1.4 million | ~$2.1 million | | Net loss | ~$2.9 million | ~$2.5 million | | Net loss per share | $0.34 | $0.60 | [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) The statements show total assets of $2.57 million, a stockholders' deficit of $6.06 million, and a Q2 net loss of $2.90 million [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets increased to $2.57 million while the total stockholders' deficit improved to $6.06 million Financial Position Comparison | Balance Sheet Item (in thousands) | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :--- | :--- | :--- | | Cash and cash equivalents | $824 | $187 | | Total current assets | $1,515 | $385 | | Total assets | $2,566 | $1,832 | | Total current liabilities | $8,528 | $8,978 | | Total liabilities | $8,623 | $9,596 | | Total stockholders' deficit | $(6,057) | $(7,764) | [Consolidated Statements of Comprehensive Loss](index=6&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) The company recorded a net loss of $2.90 million for Q2 2025 and $5.77 million for the six months ended June 30, 2025 Three Months Ended June 30 | Statement of Loss (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development, net | $1,120 | $922 | | General and administrative | $1,453 | $2,060 | | Operating loss | $(2,573) | $(2,982) | | Net loss | $(2,903) | $(2,541) | | Basic and diluted net loss per share | $(0.34) | $(0.60) | Six Months Ended June 30 | Statement of Loss (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development, net | $2,424 | $1,883 | | General and administrative | $3,238 | $3,573 | | Operating loss | $(5,662) | $(5,456) | | Net loss | $(5,767) | $(5,942) | | Basic and diluted net loss per share | $(0.77) | $(1.35) | Company and Product Overview [About NurOwn®](index=3&type=section&id=About%20NurOwn%C2%AE) NurOwn® is an investigational autologous stem cell therapy designed to deliver neurotrophic factors to sites of damage - The NurOwn® technology platform uses **autologous MSC-NTF cells** produced from a patient's own bone marrow-derived mesenchymal stem cells (MSCs)[8](index=8&type=chunk) - MSCs are converted into MSC-NTF cells, which are induced to secrete high levels of **neurotrophic factors (NTFs)**[8](index=8&type=chunk) - The therapy aims to deliver NTFs and immunomodulatory cytokines to the site of damage to slow or stabilize disease progression[8](index=8&type=chunk) [About BrainStorm Cell Therapeutics Inc.](index=3&type=section&id=About%20BrainStorm%20Cell%20Therapeutics%20Inc.) BrainStorm is a clinical-stage biotech company developing autologous stem cell therapies for neurodegenerative diseases - BrainStorm is a leading developer of **autologous adult stem cell therapies** for debilitating neurodegenerative diseases[9](index=9&type=chunk) - The lead investigational therapy, NurOwn®, has completed a Phase 3 trial in ALS and is set to launch a **Phase 3b trial** under a Special Protocol Assessment (SPA) with the FDA[10](index=10&type=chunk) - The company is also advancing a proprietary, **allogeneic exosome-based platform** and recently received a Notice of Allowance for a foundational patent[10](index=10&type=chunk) Other Information [Conference Call Information](index=2&type=section&id=Conference%20Call%20Information) The company held a conference call on August 14, 2025, to discuss Q2 results, with a replay available until August 28 - A conference call and webcast were scheduled for **8:30 a.m. Eastern Time on Thursday, August 14, 2025**[1](index=1&type=chunk)[5](index=5&type=chunk) - A replay of the conference call will be available until **August 28**[5](index=5&type=chunk)[6](index=6&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section cautions that the press release contains forward-looking statements subject to substantial risks and uncertainties - The press release contains forward-looking statements regarding the clinical development of NurOwn, potential regulatory approval, and the future success of the company[11](index=11&type=chunk) - These statements are subject to inherent uncertainties, risks, and assumptions that are difficult to predict, including the ability to **raise additional capital** and continue as a going concern[11](index=11&type=chunk)
NeuroOne Medical Technologies (NMTC) - 2025 Q3 - Quarterly Results
2025-08-14 11:46
[Executive Summary & Recent Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Recent%20Highlights) [Recent Company Highlights](index=1&type=section&id=Recent%20Company%20Highlights) NeuroOne achieved significant Q3 FY2025 financial improvements, including 105% product revenue growth, 53.9% gross margin, and an $8.2 million financing, alongside key operational milestones Key Financial Highlights for Q3 FY2025 | Metric | Q3 FY2025 | Q3 FY2024 | Change (YoY) | | :-------------------- | :---------- | :---------- | :---------- | | Product Revenue | $1.7 million | $0.8 million | +105% | | Product Gross Margin | 53.9% | 34.1% | +19.8 pp | | Operating Expenses | $2.8 million | $3.1 million | -9% | | Net Capital Raised | $8.2 million | N/A | N/A | - The first OneRF® Ablation System patient achieved one-year seizure-free status, significantly improving quality of life[3](index=3&type=chunk)[4](index=4&type=chunk) - Early FDA submission for the OneRF® Trigeminal Nerve Ablation System for facial pain treatment, with a response expected soon[4](index=4&type=chunk) - Received the first order for the sEEG drug delivery system from a major biopharmaceutical company, marking entry into a new market[4](index=4&type=chunk) - Received a key patent allowance notice from the USPTO for manufacturing methods of neural and spinal cord stimulation electrodes, enhancing competitive advantage[4](index=4&type=chunk) - Strengthened the management team by adding a Chief Medical Advisor, General Counsel, and Senior Director of Quality Assurance and Regulatory Affairs[4](index=4&type=chunk) [Management Commentary](index=1&type=section&id=Management%20Commentary) CEO Dave Rosa highlighted significant Q3 FY2025 financial and operational milestones, emphasizing OneRF® success, market expansion, and a strengthened financial position - Continued successful rollout of the OneRF® Ablation System drove significant revenue and gross profit growth[3](index=3&type=chunk) - Submitted 510(k) application for the OneRF® Trigeminal Nerve Ablation System to the FDA, with a response expected soon and potential revenue generation in calendar year 2025[5](index=5&type=chunk) - Received the first order for the sEEG drug delivery system and is discussing other potential applications with top strategic partners[5](index=5&type=chunk) - Initiated ISO 13485 certification program to prepare for international market entry, anticipating additional growth[6](index=6&type=chunk) - The intellectual property portfolio includes 17 issued and pending US and international patents, creating a significant competitive advantage[7](index=7&type=chunk) - The company's financial position is more robust, with a clearer path to profitability, driven by revenue growth and an **$8.2 million** financing[7](index=7&type=chunk) [Operational Updates](index=2&type=section&id=Operational%20Updates) [OneRF® Ablation System](index=2&type=section&id=OneRF%C2%AE%20Ablation%20System) The OneRF® Ablation System achieved significant progress, with the first patient seizure-free for one year, positive results in others, and ongoing collaboration for training and post-market studies - The first patient treated with NeuroOne's OneRF® Ablation System achieved one-year seizure-free status in June 2025[10](index=10&type=chunk) - Other patients also showed similar results, achieving seizure-free status or significantly reduced seizure frequency[10](index=10&type=chunk) - The company continues to collaborate closely with Zimmer Biomet and physician advisors for advanced training and education on this novel diagnostic and therapeutic procedure[10](index=10&type=chunk) [OneRF® Trigeminal Nerve Ablation System](index=2&type=section&id=OneRF%C2%AE%20Trigeminal%20Nerve%20Ablation%20System) NeuroOne submitted its OneRF® Trigeminal Nerve Ablation System 510(k) application to the FDA in April 2025, with a response expected soon and potential revenue by late calendar year 2025 - Submitted the 510(k) application to the FDA ahead of schedule in April 2025[10](index=10&type=chunk) - A response from the FDA is expected soon[10](index=10&type=chunk) - If FDA 510(k) approval is granted, the OneRF® Trigeminal Nerve Ablation System is expected to contribute revenue by late calendar year 2025[10](index=10&type=chunk) [OneRF® Basivertebral Nerve Ablation System (BVNA)](index=3&type=section&id=OneRF%C2%AE%20Basivertebral%20Nerve%20Ablation%20System%20%28BVNA%29) The company initiated a program to develop a OneRF® system for basivertebral nerve radiofrequency ablation (BVNA) to treat lower back pain, forming a KOL advisory board and starting chronic animal study implants - Initiated a product development program utilizing the OneRF® system for basivertebral nerve radiofrequency ablation (BVNA) to treat lower back pain[15](index=15&type=chunk) - Formed a Key Opinion Leader (KOL) advisory board for this application[15](index=15&type=chunk) - Initiated implants for chronic animal studies[15](index=15&type=chunk) [Spinal Cord Stimulation (SCS) Percutaneous Paddle Lead Program](index=3&type=section&id=Spinal%20Cord%20Stimulation%20%28SCS%29%20Percutaneous%20Paddle%20Lead%20Program) NeuroOne continues discussions with potential strategic partners to further develop and commercialize its percutaneous paddle lead for spinal cord stimulation - Continues discussions with potential strategic partners to further develop and commercialize the company's percutaneous paddle lead[15](index=15&type=chunk) [sEEG-Based Drug Delivery Program](index=3&type=section&id=sEEG-Based%20Drug%20Delivery%20Program) The company received its first order for the sEEG drug delivery system from a major biopharmaceutical company for preclinical research, marking a new market, and completed animal studies for a miniaturized system - Received the first order for the sEEG drug delivery system from a major biopharmaceutical company for preclinical research, representing a new market[15](index=15&type=chunk) - Completed animal studies for a miniaturized sEEG drug delivery system in small animals[15](index=15&type=chunk) [International Market Expansion](index=3&type=section&id=International%20Market%20Expansion) NeuroOne initiated ISO 13485 certification, crucial for international device registration and commercialization, representing a significant revenue opportunity as the company has no prior international sales - Initiated the ISO 13485 certification process, which is necessary for device registration and commercialization in many regions outside the US[15](index=15&type=chunk) - The company has not yet sold or commercialized any products in international markets, representing a potentially significant revenue opportunity[15](index=15&type=chunk) [Financial Performance](index=3&type=section&id=Financial%20Performance) [Third Quarter and Nine-Month Financial Results](index=3&type=section&id=Third%20Quarter%20and%20Nine-Month%20Financial%20Results) NeuroOne achieved significant financial improvements in Q3 FY2025 and the first nine months, with substantial product revenue growth, expanded gross margins, reduced operating expenses, and narrowed net and per-share losses [Revenue and Gross Profit](index=3&type=section&id=Revenue%20and%20Gross%20Profit) Q3 FY2025 product revenue grew **105%** to **$1.7 million**, and nine-month product revenue grew **100%** to **$6.4 million**, with gross margins expanding and **$3.0 million** in license revenue Product Revenue Overview | Metric | Q3 FY2025 | Q3 FY2024 | Change (YoY) | | :----------- | :---------- | :---------- | :---------- | | Product Revenue | $1,696,050 | $825,776 | +105% | | **Metric** | **Nine Months FY2025** | **Nine Months FY2024** | **Change (YoY)** | | Product Revenue | $6,356,767 | $3,180,719 | +100% | Product Gross Profit and Margin Overview | Metric | Q3 FY2025 | Q3 FY2024 | Change (YoY) | | :----------- | :---------- | :---------- | :---------- | | Product Gross Profit | $914,835 | $281,872 | +224.6% | | Product Gross Margin | 53.9% | 34.1% | +19.8 pp | | **Metric** | **Nine Months FY2025** | **Nine Months FY2024** | **Change (YoY)** | | Product Gross Profit | $3,612,785 | $938,605 | +284.9% | | Product Gross Margin | 56.8% | 29.5% | +27.3 pp | License Revenue Overview | Metric | Nine Months FY2025 | Nine Months FY2024 | Change (YoY) | | :----------- | :---------------- | :---------------- | :---------- | | License Revenue | $3,000,000 | $0 | N/A | [Operating Expenses](index=3&type=section&id=Operating%20Expenses) Total operating expenses decreased **9%** to **$2.8 million** in Q3 FY2025 and **5%** to **$9.5 million** for the nine months, with SG&A declining and R&D stable Operating Expenses Overview | Metric | Q3 FY2025 | Q3 FY2024 | Change (YoY) | | :----------- | :---------- | :---------- | :---------- | | Total Operating Expenses | $2,801,435 | $3,075,773 | -9% | | SG&A Expenses | $1,618,950 | $1,881,099 | -14% | | R&D Expenses | $1,182,485 | $1,194,674 | -1% | | **Metric** | **Nine Months FY2025** | **Nine Months FY2024** | **Change (YoY)** | | Total Operating Expenses | $9,468,194 | $10,009,079 | -5% | | SG&A Expenses | $5,602,818 | $6,057,520 | -8% | | R&D Expenses | $3,865,376 | $3,951,559 | -2% | [Net Loss and Earnings Per Share](index=4&type=section&id=Net%20Loss%20and%20Earnings%20Per%20Share) Net loss significantly improved to **$1.5 million** (or **$0.03** per share) in Q3 FY2025 and to **$2.0 million** (or **$0.05** per share) for the nine months Net Loss and Loss Per Share Overview | Metric | Q3 FY2025 | Q3 FY2024 | Change (YoY) | | :----------- | :---------- | :---------- | :---------- | | Net Loss | $(1,500,868) | $(2,767,525) | -45.8% | | Loss Per Share | $(0.03) | $(0.10) | -70% | | **Metric** | **Nine Months FY2025** | **Nine Months FY2024** | **Change (YoY)** | | Net Loss | $(1,986,153) | $(8,967,515) | -77.9% | | Loss Per Share | $(0.05) | $(0.35) | -85.7% | [Liquidity and Capital Position](index=4&type=section&id=Liquidity%20and%20Capital%20Position) As of June 30, 2025, NeuroOne's cash and cash equivalents increased to **$8.0 million** and working capital to **$8.7 million**, a significant improvement driven by an **$8.2 million** financing, with no outstanding debt Cash and Working Capital Overview | Metric | June 30, 2025 | September 30, 2024 | Change | | :-------------------- | :-------------- | :-------------- | :------ | | Cash and Cash Equivalents | $8.0 million | $1.5 million | +$6.5 million | | Working Capital | $8.7 million | $2.4 million | +$6.3 million | - Completed an oversubscribed institutional investor financing in April 2025, with total net proceeds of **$8.2 million**[17](index=17&type=chunk) - As of June 30, 2025, the company had no outstanding debt[17](index=17&type=chunk) [Fiscal Year 2025 Financial Guidance](index=4&type=section&id=Fiscal%20Year%202025%20Financial%20Guidance) The company maintains its FY2025 product revenue guidance of **$8.0 million** to **$10.0 million** (132% to 190% growth) and raised its product gross margin guidance to **50%** to **53%** FY2025 Financial Guidance | Metric | FY2025 Outlook | FY2024 | Growth Rate | | :----------- | :------------- | :--------- | :------- | | Product Revenue | $8.0M - $10.0M | $3.5M | 132% - 190% | | Product Gross Margin | 50% - 53% | 31% | +19 pp - +22 pp | [Additional Information](index=4&type=section&id=Additional%20Information) [About NeuroOne](index=4&type=section&id=About%20NeuroOne) NeuroOne Medical Technologies Corporation develops and commercializes minimally invasive, high-definition solutions for neurological disorders, covering EEG recording, monitoring, ablation, drug delivery, and stimulation, with potential expansion into other areas - NeuroOne is dedicated to developing and commercializing minimally invasive, high-definition solutions for EEG recording, monitoring, ablation, drug delivery, and stimulation[21](index=21&type=chunk) - Primarily targets neurological disorders such as epilepsy, Parkinson's disease, dystonia, essential tremor, and chronic pain, with potential expansion into depression, mood disorders, pain, incontinence, hypertension, and artificial intelligence[21](index=21&type=chunk) [Conference Call Details](index=4&type=section&id=Conference%20Call%20Details) Management hosted an investor conference call and webcast on August 14, 2025, to discuss Q3 FY2025 financial results and company updates, with replays available until August 28, 2025 - An investor conference call and webcast were held on Thursday, August 14, 2025, at 8:30 AM ET[19](index=19&type=chunk) - A replay of the call is available via phone and webcast link until August 28, 2025[20](index=20&type=chunk) [Legal Disclosures](index=5&type=section&id=Legal%20Disclosures) This press release contains forward-looking statements subject to risks and uncertainties, and federal law restricts device sales to or by physicians, with patient experiences not representing all outcomes - This press release may contain forward-looking statements subject to known and unknown risks, uncertainties, and other factors that could cause actual results to differ materially from expectations[22](index=22&type=chunk) - Federal law restricts this device to sale by or on the order of a physician[23](index=23&type=chunk) - Patient experiences mentioned are individual cases and do not represent all patient outcomes[24](index=24&type=chunk) [Unaudited Financial Statements](index=6&type=section&id=Unaudited%20Financial%20Statements) [Balance Sheets](index=6&type=section&id=Balance%20Sheets) The unaudited balance sheets show significant increases in NeuroOne's cash, total assets, and stockholders' equity as of June 30, 2025, reflecting a strengthened financial position after recent capital activities Balance Sheets (Unaudited) | | June 30, 2025 | September 30, 2024 | | :------------------------------------ | :-------------- | :-------------- | | **ASSETS** | | | | Cash and cash equivalents | $8,039,683 | $1,460,042 | | Inventory | $1,897,701 | $2,635,153 | | Total current assets | $10,170,747 | $4,630,925 | | Total assets | $10,819,481 | $5,369,940 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Total current liabilities | $1,425,790 | $2,213,220 | | Warrant liability | $1,040,894 | $2,140,315 | | Total liabilities | $2,642,028 | $4,547,927 | | Total stockholders' equity | $8,177,453 | $822,013 | [Statements of Operations](index=7&type=section&id=Statements%20of%20Operations) The unaudited statements of operations detail NeuroOne's Q3 FY2025 and nine-month financial performance, highlighting strong product revenue and gross profit growth, alongside significant improvements in net loss and loss per share Statements of Operations (Unaudited) | | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Nine Months Ended June 30, 2025 | Nine Months Ended June 30, 2024 | | :------------------------------------ | :---------------------- | :---------------------- | :---------------------- | :---------------------- | | Product revenue | $1,696,050 | $825,776 | $6,356,767 | $3,180,719 | | Cost of product sales | $781,215 | $543,904 | $2,743,982 | $2,242,114 | | Product gross profit | $914,835 | $281,872 | $3,612,785 | $938,605 | | License revenue | — | — | $3,000,000 | — | | Selling, general and administrative expenses | $1,618,950 | $1,881,099 | $5,602,818 | $6,057,520 | | Research and development expenses | $1,182,485 | $1,194,674 | $3,865,376 | $3,951,559 | | Total operating expenses | $2,801,435 | $3,075,773 | $9,468,194 | $10,009,079 | | Operating loss | $(1,886,600) | $(2,793,901) | $(2,855,409) | $(9,070,474) | | Net loss | $(1,500,868) | $(2,767,525) | $(1,986,153) | $(8,967,515) | | Basic and diluted net loss per share | $(0.03) | $(0.10) | $(0.05) | $(0.35) |
CoreCard(CCRD) - 2025 Q2 - Quarterly Results
2025-08-14 11:45
EXHIBIT 99.1 CoreCard Corporation Reports Second Quarter 2025 Results NORCROSS, Ga., Aug. 14, 2025 (GLOBE NEWSWIRE) -- CoreCard Corporation (NYSE: CCRD) ("CoreCard" or the "Company"), the leading provider of innovative credit technology solutions and processing services to the financial technology and services market, announced today its financial results for the quarter ended June 30, 2025. Financial Highlights for the three months ended June 30, 2025 Total revenues in the three-month period ended June 30, ...
Cassava Sciences(SAVA) - 2025 Q2 - Quarterly Results
2025-08-14 11:45
EXHIBIT 99.1 Cassava Reports Q2 2025 Financials Results and Provides Business Update AUSTIN, Texas, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, "Cassava", the "Company"), a biotechnology company focused on developing novel, investigational treatments for central nervous system (CNS) disorders such as Tuberous Sclerosis Complex (TSC)-related epilepsy, today reported financial results for the second quarter ended June 30, 2025 and provided a business update. Net loss was $44.2 mill ...
Edible Garden AG rporated(EDBL) - 2025 Q2 - Quarterly Results
2025-08-14 11:36
[Q2 2025 Performance and Strategic Update](index=1&type=section&id=Q2%202025%20Performance%20and%20Strategic%20Update) [Highlights and Strategy](index=1&type=section&id=Highlights%20and%20Strategy) Edible Garden reported strong Q2 2025 performance, driven by a strategic shift to higher-margin products and e-commerce expansion - The company is executing a portfolio transformation by exiting underperforming, low-margin product lines to focus on **higher-margin, CEA-informed, shelf-stable products**[2](index=2&type=chunk)[3](index=3&type=chunk)[7](index=7&type=chunk) Q2 2025 Key Segment Performance (YoY Growth) | Segment/Product | YoY Growth Rate | | :--- | :--- | | International Vitamin and Supplements Revenue | 66.5% | | Private Label Products | 19.1% | | Non-perishable Unit Sales | ~17% | | Hydroponic Basil | 7.1% | | Potted Herbs | 6.4% | | Wheatgrass | 4.1% | - Acquired the NaturalShrimp aquaculture facility, now Edible Garden Prairie Hills, to enhance R&D, add water treatment patents, and improve distribution efficiency[4](index=4&type=chunk) - Expanded digital footprint by launching the Kick Sports Nutrition line on Amazon, contributing to a **surge in e-commerce sales**[4](index=4&type=chunk) [Q2 2025 Financial Results](index=2&type=section&id=Q2%202025%20Financial%20Results) [Detailed Financial Performance](index=2&type=section&id=Detailed%20Financial%20Performance) Q2 2025 revenue decreased to $3.1 million due to strategic exits, leading to lower gross profit and an increased net loss of $4.0 million Q2 2025 Financial Summary (in millions) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $3.1 | $4.3 | ($1.2) | | Gross Profit | $0.63 | $1.56 | ($0.93) | | SG&A Expenses | $4.2 | $2.7 | $1.5 | | Net Loss | ($4.0) | ($1.9) | ($2.1) | - The decrease in revenue was primarily due to the strategic exit from floral and lettuce categories, accounting for **$741,000 of the decline**[7](index=7&type=chunk) - The increase in SG&A expenses was mainly driven by legal costs for the NaturalShrimp acquisition, Narayan transaction expenses, and franchise tax charges[9](index=9&type=chunk) [Financial Statements](index=3&type=section&id=Financial%20Statements) [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) Total assets increased to **$21.8 million** by June 30, 2025, driven by property and equipment, while total liabilities decreased to **$5.2 million** Selected Balance Sheet Data (in thousands) | Account | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash | $2,821 | $3,530 | | Total Current Assets | $5,889 | $7,377 | | Total Assets | $21,814 | $11,915 | | Total Current Liabilities | $3,954 | $6,210 | | Total Liabilities | $5,222 | $7,821 | | Total Stockholders' Equity (Deficit) | $1,592 | $4,094 | [Consolidated Statements of Operations](index=4&type=section&id=Consolidated%20Statements%20of%20Operations) For Q2 2025, revenue was **$3.1 million**, resulting in a **$3.6 million** operating loss and a **$13.9 million** net loss to common stockholders Statement of Operations Highlights - Three Months Ended June 30 (in thousands, except per-share data) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Revenue | $3,146 | $4,268 | | Gross Profit | $634 | $1,566 | | Loss from Operations | $(3,593) | $(1,182) | | Net Loss | $(4,043) | $(1,932) | | Net Loss Attributable to Common Stockholders | $(13,876) | $(1,932) | | Net Loss per Common Share | $(6.58) | $(30.02) | [Corporate Information](index=2&type=section&id=Corporate%20Information) [Company Profile](index=2&type=section&id=Company%20Profile) Edible Garden leads in controlled environment agriculture (CEA), delivering organic produce to over 5,000 locations using proprietary technology and a diverse product portfolio - The company is a leader in controlled environment agriculture (CEA) with products available in over **5,000 retail locations** across the U.S., Caribbean, and South America[15](index=15&type=chunk) - Owns proprietary GreenThumb 2.0 software and holds multiple U.S. patents related to greenhouse optimization, in-store displays, and advanced aquaculture technologies[16](index=16&type=chunk) - Develops and markets a growing line of nutrition and specialty food products, including Vitamin Way®, Kick. Sports Nutrition, Pulp® sauces, and Pickle Party™ fermented foods[17](index=17&type=chunk) [Conference Call Information](index=2&type=section&id=Conference%20Call%20Information) A conference call was scheduled for 8:00 A.M. Eastern Time to discuss Q2 2025 financial results and corporate developments - A conference call was scheduled for **8:00 A.M. Eastern Time** to discuss the quarterly financial results[12](index=12&type=chunk) - Details for accessing the live webcast and a telephone replay, available through **August 28, 2025**, were provided[13](index=13&type=chunk)[14](index=14&type=chunk)
Xilio Therapeutics(XLO) - 2025 Q2 - Quarterly Results
2025-08-14 11:35
[Overview and Highlights](index=1&type=section&id=Xilio%20Therapeutics%20Announces%20Pipeline%20and%20Business%20Updates%20and%20Second%20Quarter%202025%20Financial%20Results) The company announced positive Phase 2 data, progress in its T cell engager programs, and a cash runway through Q3 2026 - Announced updated Phase 2 data for vilastobart at ASCO, demonstrating **deep, durable responses** and a **differentiated safety profile** for an anti-CTLA-4 combination therapy[1](index=1&type=chunk) - The company is **on track to nominate its first development candidates** for wholly owned masked T cell engager programs in the second half of 2025[1](index=1&type=chunk) Financial Position and Runway | Metric | Value | | :--- | :--- | | Cash and cash equivalents (as of June 30, 2025) | $121.6 million | | Anticipated cash runway | Through end of Q3 2026 | [Pipeline and Business Updates](index=1&type=section&id=Pipeline%20and%20Business%20Updates) The company reports progress across its key pipeline assets, including vilastobart, XTX301, XTX501, and masked T cell engagers [Vilastobart (anti-CTLA-4)](index=1&type=section&id=Vilastobart%3A%20tumor-activated%2C%20Fc-enhanced%2C%20high%20af%20inity%20binding%20anti-CTLA-4) Phase 2 data for vilastobart showed a 26% objective response rate in certain CRC patients with a well-tolerated safety profile - Updated Phase 2 data presented at ASCO 2025 demonstrated a preliminary **26% objective response rate (ORR)** in heavily pre-treated metastatic MSS CRC patients without liver metastases[3](index=3&type=chunk) - The therapy showed a **differentiated and well-tolerated safety profile**, with a low incidence of colitis and other immune-related adverse events[3](index=3&type=chunk) - Xilio is actively engaging with strategic partners for potential opportunities to **accelerate and expand the development** of vilastobart[3](index=3&type=chunk) [XTX301 (IL-12)](index=2&type=section&id=XTX301%3A%20tumor-activated%20IL-12) The company is advancing its tumor-activated IL-12, XTX301, under an exclusive license agreement with Gilead - Xilio has an **exclusive license agreement with Gilead Sciences** for its tumor-activated IL-12 program, including XTX301[4](index=4&type=chunk) - **Enrollment in the Phase 1A monotherapy dose escalation** portion of the clinical trial has been completed, with patient evaluation ongoing[4](index=4&type=chunk) [XTX501 (PD-1/IL-2 bispecific)](index=2&type=section&id=XTX501%3A%20masked%20PD-1%2FIL-2%20bispecific) The novel tumor-activated bispecific XTX501 is progressing through IND-enabling studies, with an IND submission planned for mid-2026 - XTX501 is currently **advancing in investigational new drug (IND)-enabling studies**[5](index=5&type=chunk) - The company plans to **submit an IND application for XTX501 in the middle of 2026**[5](index=5&type=chunk) [Masked T Cell Engager Programs](index=2&type=section&id=Masked%20T%20Cell%20Engager%20Programs) The company is developing multiple preclinical masked T cell engager programs using its proprietary ATACR and SEECR formats - The pipeline includes wholly owned programs targeting **PSMA, CLDN18.2, and STEAP1**, plus a collaboration with AbbVie[6](index=6&type=chunk) - The programs utilize two proprietary formats: the bispecific **ATACR** (activated cell engager) and the tri-specific **SEECR** (selective effector-enhanced cell engager)[7](index=7&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) The company provided a development candidate timeline, closed a public offering, and appointed a new board member Development Candidate Nomination Timeline | Program | Format | Anticipated Nomination | | :--- | :--- | :--- | | PSMA | ATACR | Q3 2025 | | CLDN18.2 | ATACR | Q4 2025 | | STEAP1 | SEECR | H1 2026 | - In June 2025, Xilio closed a follow-on public offering, receiving initial gross proceeds of approximately **$50.0 million**, with potential for up to an additional **$100.0 million** if all associated warrants are exercised[9](index=9&type=chunk) - Akintunde (Tunde) Bello, Ph.D., was appointed to the company's board of directors in June 2025[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reported increased revenue and operating expenses for Q2 2025 and provided financial guidance through Q3 2026 [Q2 2025 Financial Highlights](index=3&type=section&id=Q2%202025%20Financial%20Highlights) Collaboration revenue grew to $8.1 million while net loss increased to $15.8 million, with a strengthened cash position of $121.6 million Q2 2025 Financial Performance (vs. Q2 2024) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration & License Revenue | $8.1M | $2.4M | +238% | | R&D Expenses | $15.3M | $11.2M | +37% | | G&A Expenses | $7.1M | $5.8M | +22% | | Net Loss | $15.8M | $13.9M | +14% | | Net Loss per Share | $(0.16) | $(0.24) | N/A | | Cash & Cash Equivalents (period end) | $121.6M | N/A | N/A | [Financial Guidance](index=3&type=section&id=Financial%20Guidance) The company's current cash position is expected to fund operations and capital expenditures through the end of Q3 2026 - The company expects its cash and cash equivalents as of June 30, 2025, to fund operating expenses and capital expenditure requirements **through the end of Q3 2026**[11](index=11&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) The report includes condensed consolidated balance sheets and statements of operations for the period ending June 30, 2025 [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to $133.8 million driven by a rise in cash, while total liabilities grew to $126.7 million Balance Sheet Summary (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $121,551 | $55,291 | | Total assets | $133,813 | $71,075 | | **Liabilities & Equity** | | | | Deferred revenue | $70,910 | $32,780 | | Common stock warrant liabilities | $38,550 | $0 | | Total liabilities | $126,744 | $53,477 | | Stockholders' equity | $7,069 | $17,598 | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $15.8 million for the three months ended June 30, 2025, on revenues of $8.1 million Statement of Operations Summary (in thousands) | Account | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Collaboration and license revenue | $8,084 | $2,357 | | Research and development | $15,330 | $11,216 | | General and administrative | $7,120 | $5,815 | | Total operating expenses | $22,450 | $17,061 | | Loss from operations | $(14,366) | $(14,704) | | Net loss | $(15,844) | $(13,925) | | Net loss per share | $(0.16) | $(0.24) |
MiNK Therapeutics(INKT) - 2025 Q2 - Quarterly Results
2025-08-14 11:35
EXHIBIT 99.1 MiNK Therapeutics Reports Clinical and Strategic Milestones and Second Quarter 2025 Results NEW YORK, Aug. 14, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, today announced financial results for the second quarter ended June 30, 2025, and provided a business update highlighting major clinical achievements, a strengthened balance sheet, and expanded ...
AFC Gamma(AFCG) - 2025 Q2 - Quarterly Results
2025-08-14 11:35
[Second Quarter 2025 Financial Highlights and Strategic Announcements](index=1&type=section&id=Q2_2025_Financial_Highlights_Strategic_Announcements) AFC reported a GAAP net loss of $(13.2) million and Distributable Earnings of $3.4 million, also announcing an expanded investment mandate and proposed BDC conversion [Summary of Q2 2025 Results](index=1&type=section&id=Summary_Q2_2025_Results) AFC reported a GAAP net loss of $(13.2) million and Distributable Earnings of $3.4 million for Q2 2025, with per-share figures of $(0.60) and $0.15 respectively Q2 2025 Key Financial Highlights | Metric | Amount | | :------------------------------------ | :------------- | | GAAP Net Loss | $(13.2) million | | GAAP Net Loss per Share | $(0.60) | | Distributable Earnings | $3.4 million | | Distributable Earnings per Share | $0.15 | [Key Strategic Initiatives](index=1&type=section&id=Key_Strategic_Initiatives) AFC plans to expand its investment mandate to include secured loans for ancillary cannabis and middle-market companies, and proposes converting to a BDC, pending shareholder approval - **Expansion of Investment Mandate**: Approved an amendment to include secured loans to ancillary cannabis businesses and public/private middle-market companies operating outside the cannabis industry[4](index=4&type=chunk) - **Proposed Conversion to BDC**: Intention to convert from a commercial mortgage REIT to a BDC, subject to shareholder approval, to pursue a broader array of investment opportunities[5](index=5&type=chunk) [Management Commentary](index=1&type=section&id=Management_Commentary) CEO Dan Neville emphasized resolving non-accrual credits and evaluating cannabis opportunities, highlighting the BDC conversion as a milestone to expand the investable universe beyond mortgage REIT limitations [CEO Statement](index=1&type=section&id=CEO_Statement) CEO Dan Neville highlighted the company's focus on resolving non-accrual credits and selectively evaluating opportunities with established cannabis operators, emphasizing that the proposed BDC conversion is a significant milestone, enabling the company to overcome limitations of its mortgage REIT structure in the capital-intensive cannabis industry and expand its investable universe to include non-real estate covered and ancillary businesses - **Operational Focus**: Focused on working through non-accrual credits and selectively evaluating opportunities with established operators of scale in attractive cannabis markets[3](index=3&type=chunk) - **Rationale for BDC Conversion**: The conversion would significantly expand the investable universe, allowing lending to ancillary cannabis businesses and non-real estate covered, vertically integrated operators, addressing limitations of the mortgage REIT structure in the capital-intensive cannabis industry[6](index=6&type=chunk) [Company Profile](index=2&type=section&id=Company_Profile) Advanced Flower Capital Inc. (AFCG) is a commercial mortgage REIT specializing in senior secured mortgage loans and other debt securities for cannabis industry operators in legalized states [About Advanced Flower Capital](index=2&type=section&id=About_Advanced_Flower_Capital) Advanced Flower Capital Inc. (AFCG) is a commercial mortgage real estate investment trust (REIT) primarily originating, structuring, underwriting, investing in, and managing senior secured mortgage loans and other debt securities, with a specialization in loans to cannabis industry operators in states that have legalized medical and/or adult-use cannabis - **Business Model**: Operates as a commercial mortgage REIT, primarily originating, structuring, underwriting, investing in, and managing senior secured mortgage loans and other debt securities[13](index=13&type=chunk) - **Investment Focus**: Specializes in loans to cannabis industry operators in legalized states, with loans typically secured by quality real estate assets, license value, and cash flows, ranging from **$10 million to over $100 million**[13](index=13&type=chunk) [Detailed Second Quarter 2025 Financial Performance](index=1&type=section&id=Detailed_Q2_2025_Financial_Performance) AFC reported a GAAP net loss of $(13.2) million and Distributable Earnings of $3.4 million for Q2 2025, with a detailed reconciliation of these figures and a declared common stock dividend [GAAP Net Loss and Distributable Earnings](index=1&type=section&id=GAAP_Net_Loss_Distributable_Earnings) AFC reported a GAAP net loss of $(13.2) million and Distributable Earnings of $3.4 million for Q2 2025, with per-share figures of $(0.60) and $0.15 respectively Q2 2025 Financial Results (Three Months Ended June 30, 2025) | Metric | Amount | | :------------------------------------ | :------------- | | Net (loss) income | $(13,164,651) | | Distributable earnings | $3,384,328 | | Basic weighted average shares outstanding | 22,114,341 | | Distributable earnings per basic weighted average share | $0.15 | [Reconciliation of GAAP Net Income (Loss) to Distributable Earnings](index=4&type=section&id=Reconciliation_GAAP_Net_Income_to_Distributable_Earnings) The reconciliation table details adjustments made to GAAP Net income (loss) to arrive at Distributable Earnings, showing a $14.1 million provision for current expected credit losses for Q2 2025 Reconciliation of GAAP Net Income (Loss) to Distributable Earnings (Three Months Ended June 30, 2025 vs. 2024) | Metric | June 30, 2025 | June 30, 2024 | | :------------------------------------------ | :------------- | :------------- | | Net (loss) income | $(13,164,651) | $16,446,121 | | Stock-based compensation expense | $484,502 | $369,343 | | Unrealized losses (gains) or other non-cash items | $1,055,970 | $1,420,001 | | Provision for (reversal of) current expected credit losses | $14,074,320 | $(6,190,240) | | TRS loss (income), net of dividends | $934,187 | $(624,235) | | **Distributable earnings** | **$3,384,328** | **$11,420,990** | | Basic weighted average shares outstanding | 22,114,341 | 20,400,004 | | Distributable earnings per basic weighted average share | $0.15 | $0.56 | [Common Stock Dividend](index=2&type=section&id=Common_Stock_Dividend) On July 15, 2025, Advanced Flower Capital paid a regular cash dividend of $0.15 per common share for the second quarter of 2025 to shareholders of record as of June 30, 2025 Q2 2025 Common Stock Dividend | Metric | Value | | :-------------------- | :---- | | Dividend per share | $0.15 | | Payment Date | July 15, 2025 | | Record Date | June 30, 2025 | [Strategic Business Developments](index=1&type=section&id=Strategic_Business_Developments) AFC is expanding its investment mandate to include secured loans to ancillary cannabis and middle-market companies, alongside a proposed conversion to a BDC to broaden investment opportunities [Expansion of Investment Mandate](index=1&type=section&id=Expansion_Investment_Mandate) AFC's Board approved expanding its investment mandate to include secured loans for ancillary cannabis businesses and public/private middle-market companies outside the cannabis industry, adhering to REIT obligations - **New Investment Areas**: Expanded mandate to include secured loans to ancillary cannabis businesses and public/private middle-market companies operating outside the cannabis industry[4](index=4&type=chunk) [Proposed Conversion to Business Development Company (BDC)](index=1&type=section&id=Proposed_Conversion_to_BDC) AFC announced its intention to convert from a commercial mortgage REIT to a BDC, pending shareholder approval, to significantly expand the investable universe, allowing lending to ancillary cannabis businesses and non-real estate covered operators - **Conversion Rationale**: The current mortgage REIT structure limits lending opportunities in the capital-intensive cannabis industry due to many operators not owning real estate[6](index=6&type=chunk) - **Expanded Investable Universe**: Conversion to a BDC would allow lending to ancillary cannabis businesses with high growth potential and non-real estate covered, vertically integrated operators, as well as direct lending opportunities in other private and public middle-market companies[6](index=6&type=chunk)[7](index=7&type=chunk) - **Approval Requirement**: The proposed conversion is subject to shareholder approval of a new investment advisory agreement with its Manager that complies with the Investment Company Act of 1940[8](index=8&type=chunk) [Non-GAAP Financial Measures](index=3&type=section&id=Non_GAAP_Financial_Measures) Distributable Earnings is a non-GAAP financial measure used by AFC to evaluate performance by excluding certain non-cash and GAAP adjustments not indicative of current loan activity, serving as a factor in dividend authorization [Definition and Rationale for Distributable Earnings](index=3&type=section&id=Definition_Rationale_Distributable_Earnings) Distributable Earnings is a non-GAAP financial measure used by AFC to evaluate performance by excluding certain non-cash and GAAP adjustments not indicative of current loan activity, defined as GAAP net income (loss) adjusted for specific items, and serves as a factor in dividend authorization - **Definition**: Distributable Earnings is GAAP net income (loss) excluding stock-based compensation, depreciation/amortization, unrealized gains/losses, provision for current expected credit losses, TRS (income) loss, and certain one-time non-cash charges[16](index=16&type=chunk) - **Purpose**: Used to evaluate performance by excluding effects of certain transactions and GAAP adjustments not necessarily indicative of current loan activity and operations, and is a factor considered by the Board of Directors in authorizing dividends[14](index=14&type=chunk)[17](index=17&type=chunk) - **Limitations**: It is a non-GAAP measure and should not be considered a substitute for GAAP net income; methodology may differ from other REITs, impacting comparability[18](index=18&type=chunk) [Investor Information](index=2&type=section&id=Investor_Information) Advanced Flower Capital provides investors with access to its Q2 2025 earnings presentation and Form 10-Q filing, and will host a conference call on August 14, 2025, to discuss quarterly financial results [Investor Resources and Conference Call](index=2&type=section&id=Investor_Resources_Conference_Call) Advanced Flower Capital provides investors with access to its 'Second Quarter 2025 Earnings Presentation' and its Form 10-Q filing via its website, and will host a conference call on August 14, 2025, at 10:00 am ET to discuss quarterly financial results, with options for live audio webcast and telephone participation - **Available Resources**: Q2 2025 Earnings Presentation and Quarterly Report on Form 10-Q are available on advancedflowercapital.com under the Investor Relations section[10](index=10&type=chunk)[11](index=11&type=chunk) - **Conference Call**: Scheduled for August 14, 2025, at 10:00 am ET, with live audio webcast and telephone registration available; the complete webcast will be archived for 90 days[12](index=12&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward_Looking_Statements) This section contains a standard disclaimer regarding forward-looking statements, indicating they reflect current views and projections but are subject to inherent uncertainties and risks, with no obligation to publicly update or revise them unless required by law [Disclaimer Regarding Forward-Looking Statements](index=4&type=section&id=Disclaimer_Forward_Looking_Statements) This section contains a standard disclaimer regarding forward-looking statements, indicating they reflect current views and projections but are subject to inherent uncertainties and risks, advising that actual results may differ materially due to factors such as the Manager's ability to locate loan opportunities, market demand, and credit losses, and disclaiming any obligation to publicly update or revise these statements unless required by law - **Nature of Statements**: Reflects current views and projections regarding future events and financial performance, identified by words such as 'believes,' 'expects,' 'will,' 'intends,' etc[20](index=20&type=chunk) - **Risk Factors**: Subject to inherent uncertainties, including the Manager's ability to locate suitable loan opportunities, demand for cannabis cultivation and processing facilities, and management's current estimate of expected credit losses, which could cause actual results to differ materially[20](index=20&type=chunk) - **No Obligation to Update**: The company does not undertake any obligation to publicly update or revise any forward-looking statements, except as required by law[20](index=20&type=chunk) [Contact Information](index=5&type=section&id=Contact_Information) Contact details for investor relations and media inquiries are provided for Advanced Flower Capital Inc [Investor and Media Contacts](index=5&type=section&id=Investor_Media_Contacts) Contact details for investor relations and media inquiries are provided for Advanced Flower Capital Inc - **Investor Relations Contact**: Robyn Tannenbaum, **(561) 510-2293**, ir@advancedflowercapital.com[22](index=22&type=chunk) - **Media Contact**: Collected Strategies, Jim Golden / Jack Kelleher, AFCG-CS@collectedstrategies.com[22](index=22&type=chunk)
Lexeo Therapeutics(LXEO) - 2025 Q2 - Quarterly Report
2025-08-14 11:33
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Exact Name of Registrant as Specified in its Charter) | Delaware | 85-4012572 | | --- | --- | | (State or other jurisdiction of | (I.R.S. Employer | | incorporation or organization) | Identification No.) | 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 EXCHAN ...