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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) |
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2025-08-14 11:45
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2025-08-14 11:45
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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 ...
Blue Water Biotech(BWV) - 2025 Q2 - Quarterly Report
2025-08-14 11:32
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 Number: 001-41294 Onconetix, Inc. (Exact name of registrant as specified in its charter) | Delaware | 83-2262816 | | --- | --- | | (State or ...
Onconetix(ONCO) - 2025 Q2 - Quarterly Report
2025-08-14 11:32
☒ 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 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) (Former name, former address and former fiscal year, if changed since last report) Securities registered pursuant to Section 12(b) of the Act: For the transition period from to Commission Fi ...