Senti Biosciences(SNTI) - 2025 Q2 - Quarterly Results
2025-08-07 12:06
[Management Commentary](index=1&type=section&id=Management%20Commentary) The CEO highlighted significant progress in the SENTI-202 clinical trial, including the completion of dose finding and confirmation of the recommended Phase 2 dose (RP2D), with additional efficacy and durability data anticipated by the end of 2025 - Completed dose finding and confirmed the recommended Phase 2 dose (RP2D) for the SENTI-202 Phase 1 study[2](index=2&type=chunk) - Currently enrolling additional relapsed/refractory AML patients in the dose expansion phase at the RP2D[2](index=2&type=chunk) - Expects to release additional efficacy and durability data from the ongoing Phase 1 study in Q4 2025[1](index=1&type=chunk)[2](index=2&type=chunk) [Recent Pipeline and Corporate Updates](index=1&type=section&id=Recent%20Pipeline%20and%20Corporate%20Updates) Senti Bio has made notable progress with its lead program, SENTI-202, securing FDA Orphan Drug Designation and additional grant funding, while strengthening leadership and increasing market awareness [SENTI-202 Program Highlights](index=1&type=section&id=SENTI-202%20Program%20Highlights) - The dose finding phase for the Phase 1 clinical trial of SENTI-202 (NCT06325748) for hematologic malignancies including AML is complete, and the recommended Phase 2 dose (RP2D) has been confirmed[5](index=5&type=chunk) - The U.S. FDA granted **Orphan Drug Designation** for the use of SENTI-202 to treat Acute Myeloid Leukemia (AML)[5](index=5&type=chunk) - Received an additional **$1.0 million** tranche from a California Institute for Regenerative Medicines (CIRM) grant to advance the clinical development of SENTI-202[5](index=5&type=chunk) [Corporate Developments and Market Awareness](index=1&type=section&id=Corporate%20Developments%20and%20Market%20Awareness) - Strengthened leadership with the appointment of Bryan Baum to the Board of Directors and Dr. James B. Trager to the Scientific Advisory Board[5](index=5&type=chunk) - Increased visibility through participation in various events, including Nasdaq's Amplify Spotlight Series, the 2025 SEED Conference, and virtual investor webinars hosted by Chardan and Webull[5](index=5&type=chunk)[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) For the second quarter of 2025, Senti Bio reported a net loss of $14.7 million and held $21.6 million in cash and cash equivalents, with operating expenses increasing due to higher R&D and G&A costs Key Financial Metrics (Q2 2025 vs Q2 2024) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $10.0 million | $9.2 million | +$0.8 million | | G&A Expenses | $6.8 million | $4.2 million | +$2.6 million | | Net Loss | $14.7 million | $11.2 million (from table) | +$3.5 million | | Net Loss per Share | $0.56 | $2.45 (from table) | N/A (share count changed) | Cash Position | Date | Cash and Cash Equivalents | | :--- | :--- | | June 30, 2025 | $21.6 million | | December 31, 2024 | $48.3 million | - The increase in R&D expenses was primarily due to a **$0.8 million** rise in external services and supplies costs[9](index=9&type=chunk) - The increase in G&A expenses was mainly driven by a **$2.5 million** increase in personnel-related expenses[9](index=9&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) The unaudited financial statements provide a detailed view of Senti Bio's financial position as of June 30, 2025, and its operational results for the three and six months then ended, showing a decrease in cash and total assets since year-end 2024 [Unaudited Selected Consolidated Balance Sheet Data](index=5&type=section&id=Unaudited%20Selected%20Consolidated%20Balance%20Sheet%20Data) Consolidated Balance Sheet Data (in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Cash and cash equivalents** | **$21,576** | **$48,277** | | Total assets | $68,540 | $97,841 | | Total liabilities | $43,888 | $47,086 | | Accumulated deficit | $(325,979) | $(297,134) | | Total stockholders' equity | $24,652 | $25,649 | [Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | **Operating Expenses** | | | | | | Research and development | $10,029 | $9,151 | $19,310 | $17,929 | | General and administrative | $6,769 | $4,205 | $13,885 | $11,728 | | **Total operating expenses** | **$16,798** | **$13,356** | **$33,195** | **$29,657** | | Loss from operations | $(16,798) | $(13,356) | $(33,195) | $(29,657) | | Total other income | $2,065 | $2,153 | $4,350 | $6,343 | | **Net loss** | **$(14,733)** | **$(11,203)** | **$(28,845)** | **$(23,314)** | | **Net loss per share** | **$(0.56)** | **$(2.45)** | **$(1.59)** | **$(5.10)** |
Establishment Labs(ESTA) - 2025 Q2 - Quarterly Results
2025-08-07 12:06
EXHIBIT 99.1 Second Quarter Highlights and Outlook (Unaudited) "Our US sales momentum has continued into the third quarter, allowing us to increase our worldwide and US guidance", said Peter Caldini, Chief Executive Officer. "Outside the United States, we saw sequential growth in all regions. We have growth drivers for many years to come. Higher surgeon utilization and adding accounts in the United States will drive growth for the rest of this year and into next. Approval of additional sizes will accelerate ...
Replimune(REPL) - 2026 Q1 - Quarterly Results
2025-08-07 12:05
Exhibit 99.1 Replimune Reports Fiscal First Quarter 2026 Financial Results and Provides Corporate Update Woburn, MA, August 7, 2025 – Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fiscal first quarter ended June 30, 2025 and provided a business update. The Company announced on July 22, 2025 that the U.S. Food and Drug Administration (FDA) had issued a Complete Response Lett ...
Edgewise Therapeutics(EWTX) - 2025 Q2 - Quarterly Report
2025-08-07 12:05
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: 001-40236 Edgewise Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other juris ...
RAPT Therapeutics(RAPT) - 2025 Q2 - Quarterly Results
2025-08-07 12:05
Exhibit 99.1 RAPT Therapeutics Reports Second Quarter 2025 Financial Results SOUTH SAN FRANCISCO, Calif. – August 7, 2025 – RAPT Therapeutics, Inc. (Nasdaq: RAPT) ("RAPT" or the "Company"), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, today reported financial results for the second quarter and six months ended June 30, 2025. Research and development expenses ...
BlackRock TCP Capital (TCPC) - 2025 Q2 - Quarterly Results
2025-08-07 12:05
BLACKROCK TCP CAPITAL CORP. ANNOUNCES SECOND QUARTER 2025 FINANCIAL RESULTS INCLUDING NET INVESTMENT INCOME OF $0.32 PER SHARE; DECLARES A THIRD QUARTER REGULAR DIVIDEND OF $0.25 PER SHARE AND A SPECIAL DIVIDEND OF $0.04 PER SHARE SANTA MONICA, Calif., August 7, 2025 - BlackRock TCP Capital Corp. ("we," "us," "our," "TCPC" or the "Company"), a business development company (NASDAQ: TCPC), today announced its financial results for the second quarter ended June 30, 2025 and filed its Form 10-Q with the U.S. Se ...
Barinthus(BRNS) - 2025 Q2 - Quarterly Results
2025-08-07 12:05
• Cash: As of June 30, 2025, cash, cash equivalents and restricted cash was $87.8 million, compared to $100.6 million as of March 31, 2025. The $12.8 million decrease is a result of the net cash used in operating activities of $18.1 million for the development of our pipeline and general corporate expenses, offset by a $5.3 million translational gain from the conversion of balances in pound sterling denominated entities to the United States dollar reporting currency. Based on current research and developmen ...
VACCITECH(VACC) - 2025 Q2 - Quarterly Results
2025-08-07 12:05
Barinthus Bio Reports Second Quarter 2025 Financial Results and Updates on Corporate Developments GERMANTOWN, Maryland, August 7, 2025 (GLOBE NEWSWIRE) – Barinthus Biotherapeutics plc (NASDAQ: BRNS) ("Barinthus Bio," or the "Company"), an immunology and inflammation ("I&I") company focused on developing therapies that promote immune tolerance with curative potential, today announced its financial results for the quarter ended June 30, 2025, and provided an overview of the Company's corporate developments. " ...
UroGen Pharma(URGN) - 2025 Q2 - Quarterly Report
2025-08-07 12:05
[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Unaudited financial statements for June 30, 2025, show increased revenue, a wider net loss, decreased cash, and a growing shareholders' deficit, with ongoing losses anticipated Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $92,904 | $171,987 | | Total current assets | $196,868 | $276,135 | | Total Assets | $208,717 | $285,711 | | **Liabilities & Shareholders' Deficit** | | | | Total current liabilities | $47,548 | $45,949 | | Total Liabilities | $302,093 | $294,514 | | Total Shareholders' Deficit | ($93,376) | ($8,803) | Condensed Consolidated Statements of Operations Highlights (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $24,215 | $21,848 | $44,469 | $40,629 | | Gross profit | $20,665 | $19,619 | $38,589 | $36,672 | | Operating loss | ($41,448) | ($25,839) | ($78,362) | ($51,579) | | Net Loss | ($49,940) | ($33,403) | ($93,783) | ($65,689) | | Net loss per share | ($1.05) | ($0.82) | ($1.97) | ($1.69) | Condensed Consolidated Statements of Cash Flow Highlights (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($81,849) | ($55,483) | | Net cash provided by investing activities | $2,443 | $25,516 | | Net cash provided by financing activities | $330 | $154,942 | | **Increase (Decrease) in Cash** | **($79,076)** | **$124,975** | - The company has a history of net losses, with an accumulated deficit of **$900.0 million** as of June 30, 2025. Management expects losses to continue due to the commercial launch of Zusduri and ongoing R&D activities[29](index=29&type=chunk) - Management believes that its cash, cash equivalents, and marketable securities as of June 30, 2025, are sufficient to fund operations for more than one year from the financial statement issuance date[31](index=31&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=33&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and operations, highlighting Zusduri's FDA approval and commercial launch, increased Jelmyto revenue, rising operating expenses, and sufficient liquidity for the next year [Overview and Key Developments](index=33&type=section&id=Overview%20and%20Key%20Developments) UroGen, a biotechnology company, achieved FDA approval for Zusduri on June 12, 2025, for NMIBC, and is commercially launching it while advancing its pipeline candidates - The FDA approved the New Drug Application (NDA) for Zusduri on **June 12, 2025**, for the treatment of adults with recurrent low-grade intermediate risk NMIBC[146](index=146&type=chunk)[158](index=158&type=chunk) - The company estimates the annual treatable population for Zusduri's indication in the U.S. is approximately **82,000 patients**, representing a potential market opportunity of over **$5.0 billion**[146](index=146&type=chunk) - The company's immuno-uro-oncology pipeline includes UGN-301 (anti-CTLA-4 antibody) and UGN-501 (oncolytic virus), with a **Phase 1 study** of UGN-501 planned for **2026**[145](index=145&type=chunk)[178](index=178&type=chunk) [Results of Operations](index=44&type=section&id=Results%20of%20Operations) Jelmyto revenues increased for the three and six months ended June 30, 2025, but net loss widened significantly due to higher operating, selling, marketing, and R&D expenses Comparison of Results for the Three Months Ended June 30 (in thousands) | Item | 2025 | 2024 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | $24,215 | $21,848 | $2,367 | Increased volume and price of Jelmyto sales | | R&D Expenses | $18,914 | $15,402 | $3,512 | Higher manufacturing costs for Zusduri and UGN-103 trial costs | | Selling & Marketing | $27,859 | $18,872 | $8,987 | Zusduri commercial preparation and sales force expansion | | Operating Loss | ($41,448) | ($25,839) | ($15,609) | Increased operating expenses outpaced revenue growth | | Net Loss | ($49,940) | ($33,403) | ($16,537) | Higher operating loss | Comparison of Results for the Six Months Ended June 30 (in thousands) | Item | 2025 | 2024 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | $44,469 | $40,629 | $3,840 | Increased volume of Jelmyto sales | | R&D Expenses | $38,785 | $30,896 | $7,889 | Higher manufacturing costs for Zusduri, UGN-103 trial, and IconOVir asset acquisition | | Selling & Marketing | $49,981 | $35,972 | $14,009 | Zusduri commercial preparation activities | | Operating Loss | ($78,362) | ($51,579) | ($26,783) | Increased operating expenses outpaced revenue growth | | Net Loss | ($93,783) | ($65,689) | ($28,094) | Higher operating loss | [Liquidity and Capital Resources](index=47&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held **$161.6 million** in cash and equivalents, funded operations through equity and debt, and believes current liquidity is sufficient for over one year - The company held **$161.6 million** in cash, cash equivalents, and marketable securities as of June 30, 2025[223](index=223&type=chunk) - The company has a loan agreement with Pharmakon, with an additional **$75.0 million** fourth tranche available upon Zusduri's FDA approval, which the company does not intend to draw down[230](index=230&type=chunk)[231](index=231&type=chunk) - Management believes existing cash is sufficient to fund operations **beyond one year** from the report's issuance date[236](index=236&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=52&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risks from interest rate fluctuations on its investment portfolio and foreign currency exchange rates, particularly for NIS-denominated operating expenses, without current hedging - The company's primary market risks are interest rate fluctuations on its **$161.6 million** in cash and marketable securities and foreign currency exchange risk[256](index=256&type=chunk) - A significant portion of operating expenses are incurred in New Israeli Shekels (NIS), creating exposure to currency fluctuations against the U.S. dollar; a **10% change** in the NIS-to-Dollar exchange rate would **not have had a material effect** on operating expenses for the six months ended June 30, 2025[258](index=258&type=chunk) [Controls and Procedures](index=54&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of June 30, 2025, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were **effective**[261](index=261&type=chunk) - **No changes** in internal control over financial reporting occurred during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[262](index=262&type=chunk) [PART II. OTHER INFORMATION](index=55&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=55&type=section&id=Item%201.%20Legal%20Proceedings) UroGen is engaged in patent infringement litigation against Teva Pharmaceuticals, seeking to prevent the market entry of Teva's generic Jelmyto before patent expiration, with a trial set for October 2026 - The company filed a lawsuit against Teva Pharmaceuticals on **April 2, 2024**, for patent infringement related to Teva's application to market a generic version of Jelmyto[264](index=264&type=chunk) - The lawsuit alleges infringement of U.S. Patent Numbers 9,040,074, 9,950,069, and 12,268,745, and seeks to prevent market entry of Teva's generic product; a bench trial is scheduled for **October 2026**[264](index=264&type=chunk) [Risk Factors](index=55&type=section&id=Item%201A.%20Risk%20Factors) The company faces material risks including historical losses, financing needs, dependence on product commercialization, clinical development challenges, competition, supply chain reliance, intellectual property protection, and geopolitical instability - The company has a history of significant losses (**$900.0 million** accumulated deficit as of June 30, 2025) and may require additional financing, which may not be available on acceptable terms[266](index=266&type=chunk)[270](index=270&type=chunk) - The business is **highly dependent** on the successful commercialization of its two approved products, Jelmyto and Zusduri, and faces risks related to market adoption, competition, and reimbursement[266](index=266&type=chunk)[296](index=296&type=chunk) - The company relies on third-party, **single-source suppliers** for key components of its products, creating risks of **supply chain disruption** that could impair development and commercialization[267](index=267&type=chunk)[361](index=361&type=chunk) - Significant operations in Israel expose the company to risks from **political, economic, and military instability** in the region[267](index=267&type=chunk)[553](index=553&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=131&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - The company reported **no unregistered sales** of equity securities[581](index=581&type=chunk) [Defaults Upon Senior Securities](index=131&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - The company reported **no defaults** upon senior securities[582](index=582&type=chunk) [Mine Safety Disclosures](index=131&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[582](index=582&type=chunk) [Other Information](index=131&type=section&id=Item%205.%20Other%20Information) There was no other information to report during the period - The company reported **no other information**[583](index=583&type=chunk) [Exhibits](index=132&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate documents and Sarbanes-Oxley certifications from the CEO and CFO - Exhibits filed include **CEO and CFO certifications** pursuant to **Sarbanes-Oxley Sections 302 and 906**, and the company's 2019 Inducement Plan[584](index=584&type=chunk)
Lifetime Brands(LCUT) - 2025 Q2 - Quarterly Results
2025-08-07 12:04
Exhibit 99.1 Lifetime Brands, Inc. Reports Second Quarter 2025 Financial Results Sales of $131.9 million TTM Adjusted EBITDA of $50.7 million Company Maintains Strong Liquidity Position GARDEN CITY, NY, August 7, 2025 – Lifetime Brands, Inc. (NasdaqGS: LCUT), a leading global designer, developer and marketer of a broad range of branded consumer products used in the home, today reported its financial results for the quarter ended June 30, 2025. Rob Kay, Lifetime's Chief Executive Officer, commented, "Despite ...