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Prelude Therapeutics(PRLD) - 2025 Q2 - Quarterly Results
2025-08-14 11:07
[Prelude Therapeutics Second Quarter 2025 Update](index=1&type=section&id=Prelude%20Therapeutics%20Second%20Quarter%202025%20Update) Prelude Therapeutics reports significant clinical pipeline advancements and a strong financial position for Q2 2025, with a focus on oral SMARCA2 degrader PRT7732 and a cash runway into Q2 2026 [Corporate and Pipeline Highlights](index=1&type=section&id=Corporate%20and%20Pipeline%20Highlights) Prelude Therapeutics highlights advancements in its oral SMARCA2 degrader PRT7732, strategic pipeline prioritization, and a strong cash position for Q2 2025 - The oral SMARCA2 degrader, PRT7732, is currently enrolling its seventh dosing cohort at 125 mg, with preliminary clinical data anticipated by the end of 2025[1](index=1&type=chunk) - The company has completed the Phase 1 study of its intravenous SMARCA2 degrader, PRT3789, but has paused further development to focus solely on the oral PRT7732 program[1](index=1&type=chunk)[2](index=2&type=chunk) - A development candidate for the oral KAT6A degrader program has been selected, with an Investigational New Drug (IND) application filing planned for the first half of 2026[1](index=1&type=chunk)[3](index=3&type=chunk)[7](index=7&type=chunk) - As of June 30, 2025, the company has **$77.3 million** in cash, cash equivalents, restricted cash, and marketable securities, which is expected to fund operations into the second quarter of 2026[1](index=1&type=chunk)[10](index=10&type=chunk) [Clinical Program Updates and Upcoming Milestones](index=2&type=section&id=Clinical%20Program%20Updates%20and%20Upcoming%20Milestones) Prelude strategically prioritizes its oral SMARCA2 degrader, advances its KAT6A program, and develops novel precision ADCs [SMARCA2 Degrader Development Program](index=2&type=section&id=SMARCA2%20Degrader%20Development%20Program) Prelude halts intravenous SMARCA2 degrader PRT3789 development to focus resources on the more promising oral PRT7732 due to its favorable clinical profile - The company is pausing further development of PRT3789 (IV) to focus solely on PRT7732 (oral) as the go-forward strategy for the SMARCA2 Program[2](index=2&type=chunk) - The decision was influenced by the potential need for higher target coverage and capital requirements to advance both agents simultaneously[2](index=2&type=chunk) - PRT7732 has shown a favorable clinical profile to date, including oral once-daily dosing, good safety and tolerability, and over **90% target degradation**[2](index=2&type=chunk)[3](index=3&type=chunk) [PRT3789 (Intravenous SMARCA2 Degrader)](index=2&type=section&id=PRT3789%20%E2%80%93%20A%20first-in-class%2C%20highly%20selective%2C%20intravenous%20SMARCA2%20degrader) Phase 1 clinical development for PRT3789 is complete, with further advancement contingent on partnership and final data expected by year-end 2025 - Phase 1 clinical development in patients with biomarker-selected SMARCA4-mutated cancers is complete[5](index=5&type=chunk) - Further advancement of the program is contingent on securing a partnership; internal resources are being redirected to PRT7732[5](index=5&type=chunk) - The company plans to provide updated data from the Phase 1 study by the end of 2025[5](index=5&type=chunk) [PRT7732 (Oral SMARCA2 Degrader)](index=2&type=section&id=PRT7732%20%E2%80%93%20A%20potent%2C%20highly%20selective%20and%20orally%20bioavailable%20SMARCA2%20degrader) PRT7732, an oral SMARCA2 degrader, is rapidly advancing in its Phase 1 trial, with initial data expected by year-end 2025 - Enrollment is advancing rapidly, with the seventh dose escalation cohort (125 mg once daily) currently enrolling patients[6](index=6&type=chunk) - An initial first-in-human data update, including PK/PD, safety, and initial clinical activity, is expected by year-end 2025[6](index=6&type=chunk) [KAT6A Oral Degrader Program](index=2&type=section&id=Highly%20selective%20KAT6A%20oral%20degrader%20program) Prelude is advancing a highly selective oral KAT6A degrader, targeting an IND filing in H1 2026, anticipating improved efficacy and tolerability - The company is advancing a development candidate and is on track to file an IND in the first half of 2026[7](index=7&type=chunk) - This program is developing what is believed to be the industry's first highly potent, selective, and orally bioavailable KAT6A selective degraders[7](index=7&type=chunk) - The selective degradation of KAT6A is hypothesized to offer improved efficacy, tolerability, and combinability compared to non-selective inhibitors[7](index=7&type=chunk) [Other Pipeline Programs](index=3&type=section&id=Other%20Pipeline%20Programs) Prelude is developing next-generation cancer therapies, including precision ADCs with novel SMARCA2/4 dual degrader payloads and mCALR-targeted ADCs - Developing potent SMARCA2/4 dual degraders as payloads for precision ADCs, which have shown significantly better in vivo efficacy and tolerability compared to traditional cytotoxic ADCs in preclinical models[8](index=8&type=chunk) - Developing mCALR-targeted precision ADCs for myelofibrosis (MF) and essential thrombocythemia (ET), targeting a neoantigen found in **25-35%** of patients[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) Prelude Therapeutics reported a narrowed net loss of **$31.2 million** for Q2 2025, driven by reduced operating expenses, ending the quarter with **$77.3 million** in cash Summary of Key Financial Metrics | Financial Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | R&D Expenses | $25.8M | $29.5M | -12.5% | | G&A Expenses | $6.4M | $7.7M | -16.9% | | Net Loss | $31.2M | $34.7M | -10.1% | | Net Loss Per Share | $0.41 | $0.46 | -10.9% | [Financial Position](index=3&type=section&id=Cash%2C%20Cash%20Equivalents%2C%20Restricted%20Cash%20and%20Marketable%20Securities) As of June 30, 2025, Prelude Therapeutics held **$77.3 million** in cash and equivalents, projected to fund operations into Q2 2026 - Total cash, cash equivalents, restricted cash, and marketable securities were **$77.3 million** as of June 30, 2025[10](index=10&type=chunk) - The existing cash runway is anticipated to fund operations into the second quarter of 2026[10](index=10&type=chunk) [Operating Expenses](index=3&type=section&id=Operating%20Expenses) Total operating expenses decreased in Q2 2025, with R&D expenses falling to **$25.8 million** and G&A expenses to **$6.4 million** Operating Expenses Summary | Expense Category | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Research & Development | $25.8M | $29.5M | | General & Administrative | $6.4M | $7.7M | - The decrease in R&D expenses was primarily due to a decrease in expenses related to the company's SMARCA2 clinical trials[11](index=11&type=chunk) - The decrease in G&A expenses was primarily due to lower stock-based compensation, resulting from a lower valuation on recent grants[12](index=12&type=chunk) [Net Loss](index=3&type=section&id=Net%20Loss) Prelude's net loss for Q2 2025 narrowed to **$31.2 million** (**$0.41** per share), an improvement from **$34.7 million** in Q2 2024 Net Loss Summary | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Loss | $31.2M | $34.7M | | Net Loss Per Share | $0.41 | $0.46 | - Included in the Q2 2025 net loss was **$3.8 million** of non-cash expenses related to share-based payments, down from **$6.1 million** in Q2 2024[14](index=14&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) This section presents Prelude Therapeutics' unaudited consolidated financial statements, including Statements of Operations and Balance Sheets for Q2 2025 [Statements of Operations and Comprehensive Loss](index=6&type=section&id=STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) For Q2 2025, Prelude reported total operating expenses of **$32.2 million** and a net loss of **$31.2 million**, an improvement from Q2 2024 Consolidated Statements of Operations and Comprehensive Loss | (in thousands, except per share data) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Operating expenses** | | | | Research and development | $25,784 | $29,509 | | General and administrative | $6,410 | $7,655 | | **Total operating expenses** | **$32,194** | **$37,164** | | Loss from operations | ($32,194) | ($37,164) | | Other income, net | $963 | $2,424 | | **Net loss** | **($31,231)** | **($34,740)** | | Net loss per share, basic and diluted | ($0.41) | ($0.46) | [Balance Sheets](index=7&type=section&id=BALANCE%20SHEETS) As of June 30, 2025, Prelude Therapeutics reported total assets of **$114.9 million**, total liabilities of **$39.1 million**, and stockholders' equity of **$75.8 million** Consolidated Balance Sheets | (in thousands) | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $25,752 | $12,474 | | Marketable securities | $47,464 | $121,140 | | **Total current assets** | **$76,876** | **$135,895** | | **Total assets** | **$114,918** | **$175,515** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $20,908 | $25,641 | | **Total liabilities** | **$39,080** | **$44,056** | | **Total stockholders' equity** | **$75,838** | **$131,459** | | **Total liabilities and stockholders' equity** | **$114,918** | **$175,515** |
Acuren Corp(TIC) - 2025 Q2 - Quarterly Results
2025-08-14 11:06
[Q2 2025 Performance Overview](index=1&type=section&id=Q2%202025%20Performance%20Overview) Acuren's Q2 2025 performance shows revenue growth and reduced net loss, alongside strategic insights and the NV5 merger details [Financial Highlights](index=1&type=section&id=Financial%20Highlights) Acuren's Q2 2025 revenue grew **1.5%** to **$313.9 million**, with net loss significantly reduced, though Adjusted EBITDA and margin declined - Revenue growth was primarily driven by new customer wins, increased business with existing customers, and strong performance in callout work[1](index=1&type=chunk)[3](index=3&type=chunk)[8](index=8&type=chunk) - The improvement in net loss year-over-year was attributed to the absence of prior-year seller-related stock compensation and transaction expenses, along with lower interest expense[8](index=8&type=chunk) Q2 2025 Key Financial Metrics (Successor vs. Predecessor) | Metric | Q2 2025 (Successor) | Q2 2024 (Predecessor) | Change | | :--- | :--- | :--- | :--- | | Revenue | $313.9 million | $309.3 million | +1.5% YoY | | Organic Growth | 2.0% | N/A | N/A | | Net Loss | $0.2 million | $5.5 million | Improved | | Adjusted EBITDA | $54.6 million | $59.1 million | -7.6% YoY | | Adjusted EBITDA Margin | 17.4% | 19.1% | -170 bps | [Management Commentary](index=1&type=section&id=Management%20Commentary) Management emphasized Acuren's resilient business model, strong callout work, expanded customer relationships, and the strategic benefits of the NV5 merger - CEO Tal Pizzey emphasized the strength and resilience of the business model, highlighting strong performance in callout work and expanded service offerings with existing customers[3](index=3&type=chunk) - Executive Chairman Robert A.E. Franklin stated the NV5 combination establishes a market leader with advantages in cross-selling, cost structure optimization, and a strengthened recurring revenue foundation[7](index=7&type=chunk) [Merger with NV5](index=1&type=section&id=Merger%20with%20NV5) Acuren completed its **$1.7 billion** merger with NV5 Global on August 4, 2025, creating a **$2 billion** TICC and engineering services leader - The merger with NV5 was completed on August 4, 2025, creating a market-leading **$2 billion** TICC and engineering services company[2](index=2&type=chunk) - The total transaction value was approximately **$1.7 billion**, including repayment of NV5's debt and the issuance of about **79 million** shares of Acuren common stock[10](index=10&type=chunk) - In connection with the merger, Acuren added **$875.0 million** in new term loan debt, increasing total first lien term loans to **$1.6 billion**, and expanded its revolving credit facility to **$125.0 million**[11](index=11&type=chunk) [Financial Condition and Outlook](index=2&type=section&id=Financial%20Condition%20and%20Outlook) This section reviews Acuren's capital resources, liquidity position, and the company's updated guidance plans post-NV5 merger [Capital Resources and Liquidity](index=2&type=section&id=Capital%20Resources%20and%20Liquidity) Acuren reported **$199.2 million** in total liquidity as of June 30, 2025, with **$130.1 million** in cash and **$751.3 million** in net term loan debt Liquidity and Debt as of June 30, 2025 | Item | Amount | | :--- | :--- | | Cash and cash equivalents | $130.1 million | | Undrawn revolving credit facility | $75.0 million | | **Total Liquidity** | **$199.2 million** | | Total term loan debt (net) | $751.3 million | [2025 Guidance](index=2&type=section&id=2025%20Guidance) Acuren is reviewing its financial outlook post-NV5 acquisition and will provide updated consolidated guidance with its Q3 2025 earnings in November - The company is actively reviewing its financial outlook post-NV5 acquisition and expects to provide refreshed consolidated guidance with its third quarter earnings results in November 2025[12](index=12&type=chunk) [Consolidated Financial Statements (Unaudited)](index=5&type=section&id=Consolidated%20Financial%20Statements%20(Unaudited)) This section presents Acuren's unaudited condensed consolidated balance sheets, statements of operations, and cash flows for the reported periods [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Acuren's total assets increased to **$2.24 billion** as of June 30, 2025, with total liabilities at **$1.063 billion** and equity at **$1.179 billion** Balance Sheet Summary (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $130,056 | $139,134 | | Total current assets | $399,143 | $394,236 | | Total assets | $2,242,358 | $2,207,739 | | Total current liabilities | $119,190 | $106,331 | | Long-term debt, net | $743,532 | $747,048 | | Total liabilities | $1,063,295 | $1,056,567 | | Total stockholders' equity | $1,179,063 | $1,151,172 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q2 2025 net loss improved to **$0.2 million** on **$313.9 million** revenue, while the six-month net loss widened to **$26.0 million** due to lower gross profit Q2 Statement of Operations (in thousands) | Metric | Q2 2025 (Successor) | Q2 2024 (Predecessor) | | :--- | :--- | :--- | | Service revenue | $313,925 | $309,292 | | Gross profit | $74,101 | $80,619 | | Income from operations | $18,350 | $19,749 | | Net loss | $(233) | $(5,450) | Six Months Statement of Operations (in thousands) | Metric | H1 2025 (Successor) | H1 2024 (Predecessor) | | :--- | :--- | :--- | | Service revenue | $548,140 | $532,354 | | Gross profit | $117,770 | $136,467 | | Income from operations | $8,910 | $33,743 | | Net loss | $(26,026) | $(6,721) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) H1 2025 operating cash flow was **$26.3 million**, a turnaround from prior year, with a net cash decrease of **$9.1 million** for the period Six Months Cash Flow Summary (in thousands) | Cash Flow Activity | H1 2025 (Successor) | H1 2024 (Predecessor) | | :--- | :--- | :--- | | Net cash from operating activities | $26,305 | $(8,754) | | Net cash used in investing activities | $(28,407) | $(56,627) | | Net cash (used in) provided by financing activities | $(10,308) | $8,750 | | **Net change in cash** | **$(9,078)** | **$(56,265)** | | Cash at end of period | $130,056 | $30,796 | [Reconciliation of Non-GAAP Financial Measures](index=9&type=section&id=Reconciliation%20of%20Non-GAAP%20Financial%20Measures) This section provides reconciliations for Acuren's non-GAAP financial measures, including Adjusted Gross Profit, Adjusted EBITDA, and Organic Revenue Growth [Adjusted Gross Profit and Margin](index=9&type=section&id=Adjusted%20Gross%20Profit%20and%20Margin) Q2 2025 Adjusted Gross Profit remained flat at **$90.3 million**, with the Adjusted Gross Margin slightly decreasing to **28.8%** Adjusted Gross Profit Reconciliation (in thousands) | Metric | Q2 2025 (Successor) | Q2 2024 (Predecessor) | | :--- | :--- | :--- | | Gross profit (GAAP) | $74,101 | $80,619 | | Depreciation expense | $16,219 | $9,481 | | **Adjusted gross profit (Non-GAAP)** | **$90,320** | **$90,100** | | **Adjusted gross margin** | **28.8%** | **29.1%** | [Adjusted EBITDA and Margin](index=10&type=section&id=Adjusted%20EBITDA%20and%20Margin) Q2 2025 Adjusted EBITDA decreased to **$54.6 million**, with the margin contracting to **17.4%** due to various non-recurring adjustments Adjusted EBITDA Reconciliation (in thousands) | Metric | Q2 2025 (Successor) | Q2 2024 (Predecessor) | | :--- | :--- | :--- | | Net loss (GAAP) | $(233) | $(5,450) | | EBITDA | $48,664 | $39,698 | | Adjustments | $5,897 | $19,413 | | **Adjusted EBITDA (Non-GAAP)** | **$54,561** | **$59,111** | | **Adjusted EBITDA margin** | **17.4%** | **19.1%** | [Organic Change in Service Revenue](index=11&type=section&id=Organic%20Change%20in%20Service%20Revenue) Acuren's Q2 2025 reported revenue growth was **1.5%**, with organic growth reaching **2.0%** after currency and acquisition adjustments Q2 2025 Organic Revenue Growth Reconciliation | Metric | Percentage | | :--- | :--- | | Service Revenue Change (As Reported) | 1.5% | | Foreign Currency Translation Impact | (0.6)% | | Acquisitions Impact | 0.1% | | **Organic Change In Service Revenue** | **2.0%** | [Adjusted SG&A Expenses](index=12&type=section&id=Adjusted%20SG%26A%20Expenses) Q2 2025 Adjusted SG&A expenses increased to **$36.5 million**, representing **11.6%** of service revenue, after non-recurring cost adjustments Adjusted SG&A Reconciliation (in thousands) | Metric | Q2 2025 (Successor) | Q2 2024 (Predecessor) | | :--- | :--- | :--- | | SG&A expenses (GAAP) | $55,236 | $60,870 | | Adjustments | $(18,711) | $(30,145) | | **Adjusted SG&A expenses (Non-GAAP)** | **$36,525** | **$30,725** | | **Adjusted SG&A as % of revenue** | **11.6%** | **9.9%** | [Other Information](index=2&type=section&id=Other%20Information) This section provides details on the upcoming conference call and important disclosures regarding forward-looking statements [Conference Call Information](index=2&type=section&id=Conference%20Call%20Information) Acuren will host a conference call on Thursday, August 14, 2025, at **8:30 a.m. ET** to discuss its Q2 2025 financial results - A conference call to discuss financial results is scheduled for Thursday, August 14, 2025, at **8:30 a.m. ET** (**7:30 a.m. CT**)[13](index=13&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) The report contains forward-looking statements regarding future performance and the NV5 merger, subject to risks detailed in SEC filings - The report includes forward-looking statements concerning the benefits of the NV5 merger, future growth, and financial performance, which are subject to risks and uncertainties detailed in SEC filings[18](index=18&type=chunk)[19](index=19&type=chunk)
Werewolf Therapeutics(HOWL) - 2025 Q2 - Quarterly Results
2025-08-14 11:06
Exhibit 99.1 Werewolf Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update – WTX-124 Phase 1/1b clinical trial on track for interim data readout in the fourth quarter of 2025, including patients in both the monotherapy and combination expansion arms of cutaneous melanoma and renal cell carcinoma – – Planning to engage with U.S. Food & Drug Administration (FDA) in the second half of 2025 to discuss potential registrational pathways for WTX-124 in advanced or metastatic cuta ...
Rockwell Medical(RMTI) - 2025 Q2 - Quarterly Report
2025-08-14 11:05
[Part I — Financial Information](index=3&type=section&id=Part%20I%20%E2%80%94%20Financial%20Information) [Unaudited Financial Statements](index=3&type=section&id=Item%201%20-%20Unaudited%20Financial%20Statements) This section presents Rockwell Medical's unaudited condensed consolidated financial statements for Q2 and H1 2025, detailing financial position, performance, and cash flows, along with explanatory notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $52.6 million from $59.2 million, driven by lower cash and inventory, while total liabilities also fell to $22.2 million, resulting in a decline in stockholders' equity to $30.4 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and Cash Equivalents | $12,482 | $15,662 | | Total Current Assets | $31,609 | $37,030 | | Total Assets | $52,625 | $59,208 | | **Liabilities & Equity** | | | | Total Current Liabilities | $10,946 | $14,091 | | Total Liabilities | $22,216 | $26,622 | | Total Stockholders' Equity | $30,409 | $32,586 | | Total Liabilities and Stockholders' Equity | $52,625 | $59,208 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q2 2025 saw a net loss of $1.5 million, a shift from Q2 2024 net income, driven by a **38% decrease in net sales to $16.1 million**, with the six-month net loss widening to **$3.0 million** Statements of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Net Sales | $16,071 | $25,832 | $34,985 | $48,508 | | Gross Profit | $2,503 | $4,550 | $5,545 | $7,614 | | Operating (Loss) Income | $(1,349) | $515 | $(2,709) | $(809) | | Net (Loss) Income | $(1,492) | $343 | $(3,007) | $(1,388) | | Basic Net (Loss) Income per Share | $(0.05) | $0.01 | $(0.09) | $(0.05) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$1.6 million** for H1 2025, while investing activities used **$0.1 million** and financing activities used **$1.4 million**, resulting in a **$3.2 million** net decrease in cash Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net Cash Used In Operating Activities | $(1,643) | $(938) | | Net Cash (Used In) Provided By Investing Activities | $(104) | $1,578 | | Net Cash (Used In) Provided By Financing Activities | $(1,433) | $2,243 | | **Net (Decrease) Increase in Cash** | **$(3,180)** | **$2,880** | | Cash and Cash Equivalents at End of Period | $12,482 | $11,863 | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's hemodialysis business, liquidity, significant customer concentration, the impending termination of the DaVita contract, and key accounting policies and debt agreements - The company develops, manufactures, and distributes hemodialysis products and is a leading supplier of concentrates in the United States[29](index=29&type=chunk)[30](index=30&type=chunk) - Management believes the company has sufficient funds for at least the next twelve months, with **$18.4 million in cash, cash equivalents, and investments** as of June 30, 2025. The company may raise additional capital through its **$21.1 million available ATM facility**[33](index=33&type=chunk)[34](index=34&type=chunk) - The company has significant customer concentration. For the six months ended June 30, 2025, **DaVita, Fresenius, and Nipro accounted for 20%, 10%, and 9% of total revenues**, respectively[52](index=52&type=chunk) - The company's agreement with its major customer, DaVita, was extended through December 31, 2025. However, DaVita has indicated it will transition to another supplier by mid-2025. DaVita made **non-refundable payments of $1.3 million** in the first six months of 2025 to ensure supply continuity[59](index=59&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202%20-%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, noting significant revenue decline due to DaVita's transition, a new agreement with Innovative Renal Care, sufficient liquidity for 12 months, and the resolution of a debt covenant breach [Results of Operations](index=18&type=section&id=Results%20of%20Operations) Q2 2025 net sales decreased by **38% to $16.1 million**, primarily due to reduced DaVita sales, leading to a **45% gross profit decrease**, with six-month net sales also falling **28% to $35.0 million** Results of Operations for the Three Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | % Change | | :--- | :--- | :--- | :--- | | Net Sales | $16,071 | $25,832 | (38)% | | Gross Profit | $2,503 | $4,550 | (45)% | | Operating (Loss) Income | $(1,349) | $515 | (362)% | Results of Operations for the Six Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | % Change | | :--- | :--- | :--- | :--- | | Net Sales | $34,985 | $48,508 | (28)% | | Gross Profit | $5,545 | $7,614 | (27)% | | Operating Loss | $(2,709) | $(809) | 235% | - The decrease in net sales for both the three and six-month periods was primarily driven by a significant reduction in sales to DaVita, which is transitioning to a new supplier[140](index=140&type=chunk)[146](index=146&type=chunk) [Liquidity and Capital Resources](index=19&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held **$18.4 million** in cash and investments, deemed sufficient for 12 months, with **$21.1 million** available via ATM, and a Q2 2025 revenue covenant breach was resolved - The company has approximately **$18.4 million** in cash, cash equivalents, and investments available-for-sale and believes it has sufficient funds for at least the next 12 months[152](index=152&type=chunk) - The company may raise additional capital if needed, with **$21.1 million** remaining available under its at-the-market (ATM) facility[153](index=153&type=chunk) - The company did not satisfy a revenue covenant in its loan agreement for Q2 2025 due to reduced business from DaVita, but subsequently resolved the noncompliance with the lender, Innovatus[158](index=158&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=21&type=section&id=Item%203%20-%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a Smaller Reporting Company, Rockwell Medical, Inc. is exempt from providing disclosures regarding market risk - The company is designated as a Smaller Reporting Company and is therefore not required to provide disclosure about market risk[170](index=170&type=chunk) [Controls and Procedures](index=21&type=section&id=Item%204%20-%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 CEO and CFO concluded that the company's disclosure controls and procedures were effective[172](index=172&type=chunk) - No changes occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[173](index=173&type=chunk) [Part II — Other Information](index=21&type=section&id=Part%20II%20%E2%80%94%20Other%20Information) [Legal Proceedings](index=21&type=section&id=Item%201%20-%20Legal%20Proceedings) The company does not anticipate any pending legal proceedings to materially affect its operations or financial statements - The company is not currently involved in any legal proceedings that are expected to have a material effect on its financial condition or operations[174](index=174&type=chunk) [Risk Factors](index=22&type=section&id=Item%201A%20-%20Risk%20Factors) No material changes have occurred to the risk factors previously disclosed in the company's 2024 Annual Report on Form 10-K - No material changes have occurred to the risk factors disclosed in the company's 2024 Annual Report on Form 10-K[175](index=175&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=22&type=section&id=Item%202%20-%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[175](index=175&type=chunk) [Defaults Upon Senior Securities](index=22&type=section&id=Item%203%20-%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[176](index=176&type=chunk) [Mine Safety Disclosures](index=22&type=section&id=Item%204%20-%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[177](index=177&type=chunk) [Other Information](index=22&type=section&id=Item%205%20-%20Other%20Information) The company reported no other information - None[178](index=178&type=chunk) [Exhibits](index=22&type=section&id=Item%206%20-%20Exhibits) This section provides an index of exhibits filed or furnished as part of the Quarterly Report on Form 10-Q, including incentive plans and officer certifications - The report includes an exhibit index listing documents filed or furnished, such as the Amended and Restated 2018 Long Term Incentive Plan, officer certifications (31.1, 31.2, 32.1, 32.2), and XBRL data files[179](index=179&type=chunk)[180](index=180&type=chunk)
Protalix BioTherapeutics(PLX) - 2025 Q2 - Quarterly Report
2025-08-14 11:05
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) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to 2 University Plaza Suite 100 Hackensack, NJ 07601 (Address of principal executive offices) (Zip Code) (201)-696-9345 001-33357 (Commission file number) PROT ...
Evoke Pharma(EVOK) - 2025 Q2 - Quarterly Results
2025-08-14 11:05
Evoke Pharma Reports Second Quarter 2025 Financial Results and Provides Business Update Q2 2025 Net Product Sales Increased 47% Year-over-Year to $3.8 Million SOLANA BEACH, Calif., August 14, 2025 (GLOBE NEWSWIRE) – Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders with an emphasis on GIMOTI® (metoclopramide) nasal spray, today reported financial results for the second quarter ended June 30, 2025, and provided a business update. " ...
BK Technologies(BKTI) - 2025 Q2 - Quarterly Results
2025-08-14 11:04
[Q2 2025 Performance Overview](index=1&type=section&id=Q2%202025%20Performance%20Overview) This section provides an overview of the company's strong Q2 2025 performance, including CEO commentary and key financial highlights [CEO Commentary and Business Update](index=1&type=section&id=CEO%20Commentary%20and%20Business%20Update) The CEO highlighted strong Q2 2025 operational execution, achieving higher-than-expected gross margins and improved profitability - Delivered strong operational performance in Q2 2025, with gross margins reaching **47.4%**[3](index=3&type=chunk) - Federal order activity increased significantly after the quarter, highlighted by **$12.9 million** in purchase orders from the USDA Forest Service, suggesting a strong outlook for the second half of the year[3](index=3&type=chunk)[5](index=5&type=chunk) - Launched RelayONE, a new rapid deployment portable repeater kit, and received the first purchase order from the Latimer County Sheriff's Office in Colorado[3](index=3&type=chunk) [Q2 2025 Financial Highlights](index=1&type=section&id=Q2%202025%20Financial%20Highlights) BK Technologies reported strong Q2 2025 financial results, with revenue at **$21.2 million** and gross margin significantly improving to **47.4%** Q2 2025 Key Financial Metrics vs. Q2 2024 | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Revenue | $21.2 million | $20.3 million | | Gross Margin | 47.4% | 37.3% | | GAAP Diluted EPS | $0.96 | $0.47 | | Non-GAAP Adj. Diluted EPS | $1.30 | $0.55 | [Financial Performance Analysis](index=2&type=section&id=Financial%20Performance%20Analysis) This section analyzes the company's Q2 and first-half 2025 financial performance, including balance sheet insights [Second Quarter 2025 Financial Review](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Review) Q2 2025 revenue increased **4.5%** to **$21.2 million**, with gross margin expanding to **47.4%** Q2 2025 vs. Q2 2024 Performance | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $21.2M | $20.3M | +4.5% | | Gross Margin | 47.4% | 37.3% | +10.1 p.p. | | Operating Income | $4.0M | $2.0M | +100% | | Net Income | $3.7M | $1.7M | +117.6% | - The improvement in gross margin was driven by a favorable product mix and ongoing cost savings from operational efficiencies and outsourced manufacturing[7](index=7&type=chunk) - Selling, General & Administrative (SG&A) expenses rose to **$6.0 million** from **$5.5 million** year-over-year, reflecting continued investments in sales, marketing, and engineering[8](index=8&type=chunk) [Six Months 2025 Financial Review](index=3&type=section&id=Six%20Months%202025%20Financial%20Review) First-half 2025 revenue grew **4.5%** to **$40.2 million**, with gross margin improving to **47.2%** First Half 2025 vs. First Half 2024 Performance | Metric | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $40.2M | $38.5M | +4.5% | | Gross Margin | 47.2% | 35.9% | +11.3 p.p. | | Operating Income | $6.9M | $3.0M | +130% | | Net Income | $5.9M | $2.3M | +157.4% | [Balance Sheet and Working Capital](index=3&type=section&id=Balance%20Sheet%20and%20Working%20Capital) As of June 30, 2025, working capital increased to **$28.9 million**, driven by higher cash and receivables - Working capital totaled approximately **$28.9 million** at June 30, 2025, an increase from **$23.0 million** at December 31, 2024[11](index=11&type=chunk) - Cash, cash equivalents, and trade receivables grew to **$23.4 million**, up from **$14.4 million** at the end of 2024[11](index=11&type=chunk) Key Balance Sheet Items (in thousands) | Account | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $11,853 | $7,075 | | Total current assets | $44,833 | $36,941 | | Total liabilities | $23,663 | $21,668 | | Total stockholders' equity | $36,763 | $29,831 | [Full Year 2025 Outlook](index=2&type=section&id=Full%20Year%202025%20Outlook) BK Technologies has raised its full-year 2025 financial guidance due to strong year-to-date performance and robust demand Updated Full Year 2025 Guidance | Metric | New Guidance | Prior Guidance | | :--- | :--- | :--- | | Revenue Growth | High single digits | Single-digit growth | | Gross Margin | > 47% | > 42% | | GAAP Diluted EPS | $3.15 | $2.40 | | Non-GAAP Adj. Diluted EPS | $3.80 | $2.80 | - The upward revision is attributed to strong demand, leverage in the business model, and confidence in sustaining higher performance levels[6](index=6&type=chunk) [Appendix](index=5&type=section&id=Appendix) This section provides supplementary information, including non-GAAP financial measures and detailed financial statements [Use of Non-GAAP Measures](index=5&type=section&id=Use%20of%20Non-GAAP%20Measures) The company uses non-GAAP financial measures to supplement GAAP statements, offering clearer insight into core operational performance - Adjusted EBITDA is used to help investors understand operational factors by excluding interest, taxes, depreciation, amortization, stock-based compensation, and other infrequent charges[21](index=21&type=chunk) - Adjusted EPS adjusts GAAP EPS for items that management does not see as reflective of core operating performance, such as stock-based compensation and one-time charges related to manufacturing transition and tax provisions[22](index=22&type=chunk) [Financial Statements](index=8&type=section&id=Financial%20Statements) This section provides unaudited condensed consolidated financial statements for Q2 and H1 2025, including key financial statements and non-GAAP reconciliations [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q2 2025 income statement shows net sales of **$21.2 million** and net income of **$3.7 million** Q2 & H1 2025 Income Statement Highlights (in thousands) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Sales, net | $21,165 | $20,254 | $40,219 | $38,485 | | Operating income | $3,997 | $2,025 | $6,913 | $3,008 | | Net income | $3,741 | $1,664 | $5,873 | $2,345 | | Diluted EPS | $0.96 | $0.47 | $1.51 | $0.66 | [Condensed Consolidated Balance Sheets](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, the balance sheet indicates total assets of **$60.4 million** Balance Sheet Summary (in thousands) | Account | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Total current assets | $44,833 | $36,941 | | Total assets | $60,426 | $51,499 | | Total liabilities | $23,663 | $21,668 | | Total stockholders' equity | $36,763 | $29,831 | [Reconciliation of Non-GAAP Financial Measures](index=10&type=section&id=Reconciliation%20of%20Non-GAAP%20Financial%20Measures) This table reconciles GAAP Net Income to non-GAAP Adjusted EBITDA and Adjusted Earnings for Q2 2025 Q2 2025 GAAP to Non-GAAP Reconciliation (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Income (GAAP) | $3,741 | $1,664 | | Adjusted EBITDA (Non-GAAP) | $4,417 | $2,489 | | Adjusted Earnings (Non-GAAP) | $5,055 | $1,974 | | Adjusted EPS - diluted (Non-GAAP) | $1.30 | $0.55 |
ABVC BioPharma(ABVC) - 2025 Q2 - Quarterly Results
2025-08-14 11:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 8-K Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 193 ...
Larimar Therapeutics(LRMR) - 2025 Q2 - Quarterly Results
2025-08-14 11:02
Exhibit 99.1 study. • Strengthened Balance Sheet With $65.1 Million Public Offering: In July 2025, Larimar announced a public offering of common stock with net proceeds of $65.1 million supported by existing and new leading healthcare investors that extends its projected cash runway into the fourth quarter of 2026. Larimar Therapeutics Reports Second Quarter 2025 Financial Results *Pro forma cash, cash equivalents, and marketable securities of $203.6 million reflects $138.5 million of cash, cash equivalents ...
Onconova Therapeutics(ONTX) - 2025 Q2 - Quarterly Results
2025-08-14 11:01
Exhibit 99.1 Traws Pharma Reports Second Quarter 2025 Results and Business Highlights Advancing novel programs for respiratory viruses that pose pandemic threats or risk of serious illness, including SARS CoV2 (ratutrelvir) and influenza (Tivoxavir marboxil, TXM) Prioritization of ratutrelvir, a ritonavir-free, protease inhibitor regimen in development for Acute and Long COVID, reflects the ongoing infection risk and greater need, with waning vaccine utilization A submitted HREC study will enable initiation ...