Skye Bioscience Inc.(SKYE) - 2025 Q2 - Quarterly Results
2025-08-07 20:06
Skye Bioscience Reports Second Quarter 2025 Financial Results and Business Update SAN DIEGO, CA, August 7, 2025 -- Skye Bioscience, Inc. (NASDAQ: SKYE) ("Skye" or the "Company"), a clinical stage biotechnology company developing next-generation molecules that modulate G-protein-coupled receptors to treat obesity, overweight, and related conditions, today reported financial results for the second quarter ended June 30, 2025, along with key accomplishments and upcoming milestones. "As we eagerly await the 26- ...
Medalist Diversified REIT(MDRR) - 2025 Q2 - Quarterly Report
2025-08-07 20:06
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No: 001-38719 MEDALIST DIVERSIFIED REIT, INC. Indicate by check mark whether the registrant has submitted electronically e ...
Texas Roadhouse(TXRH) - 2025 Q2 - Quarterly Results
2025-08-07 20:06
LOUISVILLE, KY. (August 7, 2025) – Texas Roadhouse, Inc. (NasdaqGS: TXRH), today announced financial results for the 13 and 26 weeks ended July 1, 2025. Financial Results Financial results for the 13 and 26 weeks ended July 1, 2025 and June 25, 2024 were as follows: Exhibit 99.1 Texas Roadhouse, Inc. Announces Second Quarter 2025 Results Declares Quarterly Dividend of $0.68 per Share | ($000's, except per share | 13 Weeks Ended | | | | 26 Weeks Ended | | | | --- | --- | --- | --- | --- | --- | --- | --- | | ...
AvePoint(AVPT) - 2025 Q2 - Quarterly Results
2025-08-07 20:06
EXHIBIT 99.1 AvePoint Announces Second Quarter 2025 Financial Results Total quarterly revenue surpassed $100 million for the first time Second quarter SaaS revenue of $77.3 million, representing 44% year-over-year growth, 40% on a constant currency basis Second quarter Total revenue of $102.0 million, representing 31% year-over-year growth, 27% on a constant currency basis Total ARR of $367.6 million, representing 27% year-over-year growth JERSEY CITY, N.J., Aug. 07, 2025 (GLOBE NEWSWIRE) -- AvePoint (NASDA ...
Celldex Therapeutics(CLDX) - 2025 Q2 - Quarterly Report
2025-08-07 20:06
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 000-15006 CELLDEX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware No. 13-3191702 (I.R.S. Employer Identification No.) (State ...
Advantage Solutions(ADV) - 2025 Q2 - Quarterly Report
2025-08-07 20:06
OR FORM 10-Q QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38990 Advantage Solutions Inc. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organiza ...
NeuroBo Pharmaceuticals(NRBO) - 2025 Q2 - Quarterly Report
2025-08-07 20:06
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 001-37809 METAVIA INC. (Exact name of Registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 (Mark One) Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 Table of Contents Not applicable (Former name, former add ...
sair Gaming(CRSR) - 2025 Q2 - Quarterly Results
2025-08-07 20:06
Exhibit 99.1 Corsair Reports Strong Q2 2025 with Double-Digit Year-Over-Year Growth in Revenue and Gross Profit MILPITAS, CA, August 7, 2025 – Corsair Gaming, Inc. (Nasdaq: CRSR) ("Corsair" or the "Company"), a leading global provider and innovator of high-performance products for gamers, streamers, content-creators, gaming PC builders and SIM driving enthusiasts, today announced its financial results for the second quarter ended June 30, 2025. Corsair delivered another strong quarter, achieving double-digi ...
Iovance Biotherapeutics(IOVA) - 2025 Q2 - Quarterly Results
2025-08-07 20:06
[Financial and Corporate Highlights](index=1&type=section&id=Financial%20and%20Corporate%20Highlights) Iovance reported strong Q2 2025 results with $60.0 million in total product revenue, a 93% YoY increase, driven by Amtagvi sales and a strategic restructuring to extend cash runway Key Financial Metrics | Metric | Q2 2025 | YoY Change | FY25 Guidance | | :--- | :--- | :--- | :--- | | Total Product Revenue | $60.0 million | +93% | $250 million - $300 million | - More than **100 patients** were treated with Amtagvi® in the second quarter of 2025, indicating strong U.S. adoption in advanced melanoma[1](index=1&type=chunk)[2](index=2&type=chunk) - A strategic restructuring is being implemented to extend the company's cash runway into the **fourth quarter of 2026**[17](index=17&type=chunk) [Amtagvi Commercialization and Market Expansion](index=2&type=section&id=Amtagvi%20Commercialization%20and%20Market%20Expansion) Amtagvi's U.S. launch expands with over 80 ATCs and strong real-world data, while international approvals are progressing in Canada, UK, and Australia [U.S. Launch Highlights](index=2&type=section&id=U.S.%20Launch%20Highlights) Amtagvi's U.S. launch expands to over 80 ATCs, showing a 48.8% ORR in real-world data, with improved manufacturing turnaround - A real-world retrospective study of commercial Amtagvi showed a physician-assessed objective response rate (ORR) of **48.8%**, with a higher ORR of **60.9%** in patients treated in the third-line or earlier[6](index=6&type=chunk) - The treatment network has expanded to **over 80 U.S. Authorized Treatment Centers (ATCs)**, with **95%** of addressable patients living within 200 miles of a center[6](index=6&type=chunk) - A new specialty pharmacy agreement with Biologics by McKesson has been established to provide an additional access channel for providers, particularly large community practices[6](index=6&type=chunk) - Commercial manufacturing turnaround time has improved to **33 days** from inbound tumor tissue to return shipment of Amtagvi to ATCs[6](index=6&type=chunk) [International Regulatory and Commercialization Strategy](index=2&type=section&id=International%20Regulatory%20and%20Commercialization%20Strategy) Amtagvi's international strategy includes imminent Canadian approval, a new EU approach, and 2026 reviews in the UK and Australia - Health Canada is expected to approve Amtagvi monotherapy in the coming weeks, with a commercial launch to follow[6](index=6&type=chunk) - The company withdrew its marketing authorization application (MAA) from the European Medicines Agency (EMA) and is developing a new strategy for EU accessibility[6](index=6&type=chunk) - Regulatory reviews are on track for potential approval and launch in the United Kingdom (**H1 2026**) and Australia (**early 2026**), with a Swiss submission planned for **Q4 2025**[6](index=6&type=chunk) [Clinical Pipeline Update](index=3&type=section&id=Clinical%20Pipeline%20Update) Iovance advances its TIL pipeline with strong momentum in frontline melanoma, upcoming data for NSCLC and endometrial cancer, and progress in next-gen therapies [Lifileucel Franchise Programs](index=3&type=section&id=Lifileucel%20Franchise%20Programs) Lifileucel programs advance with TILVANCE-301 in melanoma, IOV-LUN-202 data for NSCLC in H2 2025, and initial IOV-END-201 results for endometrial cancer - **Frontline Advanced Melanoma:** The registrational TILVANCE-301 trial of Amtagvi in combination with pembrolizumab continues with strong momentum[10](index=10&type=chunk) - **Advanced NSCLC:** On track to share additional data in **H2 2025** from the IOV-LUN-202 registrational trial to support a potential U.S. accelerated approval in **2027**[10](index=10&type=chunk) - **Endometrial Cancer:** The IOV-END-201 Phase 2 trial is actively enrolling, with initial results expected in the **second half of 2025**[10](index=10&type=chunk) [Next Generation TIL Pipeline](index=3&type=section&id=Next%20Generation%20TIL%20Pipeline) Next-gen TIL pipeline progresses with IOV-4001 Phase 2 results in H2 2025, ongoing enrollment for IOV-3001, and IOV-5001 IND submission in early 2026 - **IOV-4001 (PD-1 Inactivated TIL):** Results from the Phase 2 efficacy portion of the IOV-GM1-201 trial are anticipated in the **second half of 2025**[10](index=10&type=chunk) - **IOV-3001 (Next Gen IL-2):** Patient enrollment is ongoing in a Phase 1/2 clinical trial to investigate this modified IL-2 analog for use in the TIL therapy regimen[10](index=10&type=chunk) - **IOV-5001 (Cytokine-Tethered TIL):** IND-enabling studies are proceeding for this genetically engineered TIL therapy, with an IND submission planned for **early 2026**[10](index=10&type=chunk) [Publications and Presentations](index=3&type=section&id=Publications%20and%20Presentations) Recent publications highlight lifileucel's long-term efficacy, including a 31.4% ORR in advanced melanoma and 50% ORR in mucosal melanoma - The final five-year analysis of the Phase 2 C-144-01 trial was published, showing an ORR of **31.4%**, a median duration of response of **36.5 months**, and a five-year overall survival of **19.7%** in previously treated advanced melanoma[10](index=10&type=chunk) - A peer-reviewed letter published in *Cancer Communications* reported a **50% ORR** in patients with advanced mucosal melanoma treated with lifileucel, with the median duration of response not reached[10](index=10&type=chunk) [Corporate Updates](index=4&type=section&id=Corporate%20Updates) Iovance implements a strategic restructuring with a 19% workforce reduction for over $100 million in savings, extending cash runway into Q4 2026 - A strategic restructuring is being implemented, including a **19% workforce reduction**, to generate **over $100 million** in annual cost savings starting in **Q4 2025**[17](index=17&type=chunk) - As of June 30, 2025, the company had approximately **$307.1 million** in cash, cash equivalents, investments, and restricted cash, which is expected to fund operations into **Q4 2026**[17](index=17&type=chunk) - The company's patent portfolio includes approximately **280 granted or allowed patents**, providing intellectual property exclusivity for Amtagvi and related technologies through **at least 2042**[17](index=17&type=chunk) [Detailed Financial Results](index=4&type=section&id=Detailed%20Financial%20Results) Iovance reported Q2 2025 total revenue of $60.0 million and a net loss of $111.7 million, driven by Amtagvi launch and increased R&D and Cost of Sales [Revenue](index=4&type=section&id=Revenue) Q2 2025 total product revenue reached $60.0 million, a 93% YoY increase, primarily from Amtagvi sales, with H1 2025 revenue at $109.3 million Revenue Breakdown | Revenue Breakdown (in millions) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Amtagvi Revenue | $54.1 | $12.8 | $97.7 | $12.8 | | Proleukin Revenue | $5.9 | $18.3 | $11.6 | $19.0 | | **Total Product Revenue** | **$60.0** | **$31.1** | **$109.3** | **$31.8** | [Costs and Expenses](index=4&type=section&id=Costs%20and%20Expenses) Total costs and expenses for Q2 2025 increased to $173.7 million, driven by higher Cost of Sales and R&D expenses, while SG&A decreased Costs and Expenses Breakdown | Costs and Expenses (in millions) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Cost of Sales | $56.7 | $31.4 | $106.4 | $38.6 | | Research & Development | $79.4 | $62.1 | $156.2 | $141.9 | | Selling, General & Administrative | $37.7 | $39.6 | $81.6 | $71.0 | | **Total Costs and Expenses** | **$173.7** | **$133.0** | **$344.3** | **$251.5** | [Net Loss](index=4&type=section&id=Net%20Loss) Iovance reported a Q2 2025 net loss of $111.7 million ($0.33 per share) and a H1 2025 net loss of $227.8 million ($0.69 per share) Net Loss Summary | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Net Loss (in millions) | $(111.7) | $(97.1) | $(227.8) | $(210.1) | | Net Loss Per Share | $(0.33) | $(0.34) | $(0.69) | $(0.76) | [Financial Statements](index=8&type=section&id=Financial%20Statements) Financial statements detail the balance sheet as of June 30, 2025, with $907.4 million in total assets, and consolidated statements of operations [Selected Condensed Consolidated Balance Sheets](index=8&type=section&id=Selected%20Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, the balance sheet shows $301.2 million in cash and investments, $907.4 million in total assets, and $698.5 million in equity Selected Condensed Consolidated Balance Sheets | Balance Sheet (in thousands) | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, and investments | $301,183 | $323,781 | | Restricted cash | $5,944 | $6,359 | | Total assets | $907,437 | $910,426 | | Stockholders' equity | $698,488 | $710,405 | [Condensed Consolidated Statements of Operations](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Statements of operations detail revenues and expenses for Q2 and H1 2025, showing a Q2 total revenue of $60.0 million and a net loss of $111.7 million Condensed Consolidated Statements of Operations | Statement of Operations (in thousands) | For the Three Months Ended June 30, | For the Six Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | **Total revenue** | **$59,952** | **$31,106** | **$109,276** | **$31,821** | | Cost of sales | $56,664 | $31,368 | $106,405 | $38,629 | | Research and development | $79,363 | $62,084 | $156,242 | $141,867 | | Selling, general and administrative | $37,699 | $39,568 | $81,624 | $70,961 | | **Total costs and expenses** | **$173,726** | **$133,020** | **$344,271** | **$251,457** | | Loss from operations | $(113,774) | $(101,914) | $(234,995) | $(219,636) | | **Net Loss** | **$(111,658)** | **$(97,101)** | **$(227,821)** | **$(210,077)** | | **Net Loss Per Share, Basic and Diluted** | **$(0.33)** | **$(0.34)** | **$(0.69)** | **$(0.76)** |
Verastem(VSTM) - 2025 Q2 - Quarterly Report
2025-08-07 20:06
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ 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: 001-35403 Verastem, Inc. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdict ...