Stoke Therapeutics(STOK) - 2025 Q2 - Quarterly Report
2025-08-12 20:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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 ☐ 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: 001-38938 Stoke Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdi ...
TherapeuticsMD(TXMD) - 2025 Q2 - Quarterly Results
2025-08-12 20:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED): August 12, 2025 THERAPEUTICSMD, INC. (Exact Name of Registrant as Specified in its Charter) Nevada 001-00100 87-0233535 (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.) | | | Name of Each Exchange on Which | | --- | --- | --- | | Title of ...
Mobile Infrastructure (BEEP) - 2025 Q2 - Quarterly Results
2025-08-12 20:15
[Executive Summary & Business Update](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Update) [Second Quarter 2025 Performance Overview](index=1&type=section&id=Second%20Quarter%202025%20Performance%20Overview) Mobile Infrastructure Corporation's Q2 2025 performance met expectations, remaining stable year-over-year despite construction and weather impacts, with growth in contract parking and higher transient parking rates offsetting volume decline - Q2 2025 performance met expectations, largely stable year-over-year despite adverse construction and weather-related factors[2](index=2&type=chunk) - Contract parking volume grew **2.5%** in Q2 and **6.6%** year-to-date, reflecting the company's strategic focus on improving asset utilization[2](index=2&type=chunk) - Transient parking volume continued to decline due to unfavorable weather, fewer special events and lower attendance, and construction impacts at some locations[2](index=2&type=chunk) - Despite the decline in transient parking volume, rates increased both year-over-year and quarter-over-quarter, indicating strong positioning of core assets driven by multiple demand factors[2](index=2&type=chunk) [Strategic Initiatives](index=1&type=section&id=Strategic%20Initiatives) The company is disciplined in managing operating and G&A expenses, implementing a three-year asset rotation strategy to divest non-core assets, optimize the balance sheet, and reinvest in assets with higher NOI potential - The company maintains disciplined management of operating and general and administrative expenses to achieve significant operating leverage as revenue grows[3](index=3&type=chunk) - Refinancing discussions are underway for debt maturing in 2026 and 2027, aiming to increase financial flexibility and resources for long-term growth[3](index=3&type=chunk) - Progress is being made on a three-year asset rotation strategy, with active negotiations for approximately **$20 million** in asset sales[3](index=3&type=chunk) - Plans to utilize net proceeds from asset sales to optimize the balance sheet and reinvest in fewer, larger assets with multiple demand drivers and higher net operating income potential[3](index=3&type=chunk) - Target to divest approximately **$100 million** in non-core assets over the next three years[3](index=3&type=chunk) [Outlook and Guidance](index=3&type=section&id=Outlook%20and%20Guidance) The company anticipates similar business trends in H2 2025 as H1, with potential upside from seasonality and increased event participation, but full-year revenue and NOI guidance are expected at the low end due to key asset construction delays - Business trends in H2 2025 are expected to be similar to H1, with potential upside from seasonal factors and increased event participation and hotel occupancy in key markets[12](index=12&type=chunk) - Based on delays in key asset construction and year-to-date performance, the 2025 full-year revenue guidance (**$37 million to $40 million**) and Net Operating Income guidance (**$23.5 million to $25 million**) are expected to be at the low end of their respective ranges[12](index=12&type=chunk) - The company will continue to conservatively manage its balance sheet and focus on growing recurring cash flow and enhancing the long-term value of its portfolio[12](index=12&type=chunk) - Positioned to capture sustainable long-term demand and create shareholder value, benefiting from long-term trends such as urban residential revitalization and the return of office/hybrid work models[13](index=13&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) [Second Quarter 2025 Financial Highlights](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Highlights) In Q2 2025, total revenue decreased by 3.0% year-over-year, net loss expanded to **$4.7 million**, NOI and Adjusted EBITDA declined, while interest expense significantly increased Key Financial Metrics for Q2 2025 | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | YoY Change (%) | | :------------------- | :----------------------- | :----------------------- | :----------- | | Total Revenue | 9.0 | 9.3 | -3.0% | | Net Loss | 4.7 | 2.5 | +88.0% | | Net Operating Income (NOI) | 5.4 | 5.6 | -3.5% | | Adjusted EBITDA | 3.8 | 4.1 | -7.3% | | Revenue Per Available Space (RevPAS) | 212 | 217 | -2.3% | - Interest expense for Q2 2025 was **$4.7 million**, a significant increase from **$3.1 million** in Q2 2024, primarily due to the revolving credit facility obtained in September 2024, with an outstanding balance of **$29.5 million** as of June 30, 2025[7](index=7&type=chunk) - As of June 30, 2025, the company held **$15.9 million** in cash, cash equivalents, and restricted cash, with total debt (including credit facility and notes payable) of **$214.3 million**[10](index=10&type=chunk) [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) Total revenue decreased by 3.0% year-over-year in Q2 2025, mainly due to a significant reduction in percentage rent revenue, while net loss expanded significantly due to increased interest and D&A expenses, partially offset by lower G&A Consolidated Statements of Operations Summary for Q2 2025 (Thousands of USD) | Metric | Q2 2025 | Q2 2024 | YoY Change (%) | | :----------------------- | :------------- | :------------- | :----------- | | Managed Property Revenue | $7,441 | $7,226 | +3.0% | | Base Rent Revenue | $1,447 | $1,523 | -5.0% | | Percentage Rent Revenue | $104 | $517 | -79.9% | | **Total Revenue** | **$8,992** | **$9,266** | **-3.0%** | | Property Taxes | $1,779 | $1,809 | -1.7% | | Property Operating Expenses | $1,778 | $1,824 | -2.5% | | Depreciation and Amortization | $2,867 | $2,096 | +36.7% | | General and Administrative Expenses | $2,071 | $2,909 | -28.8% | | **Total Expenses** | **$8,847** | **$8,898** | **-0.6%** | | Interest Expense, Net | $(4,704) | $(3,087) | +52.4% | | **Net Loss** | **$(4,661)** | **$(2,469)** | **+88.8%** | | Net Loss Attributable to Common Stockholders | $(4,498) | $(1,843) | +144.1% | | Basic and Diluted Loss Per Share | $(0.11) | $(0.06) | +83.3% | [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets slightly decreased from year-end 2024, mainly due to lower net real estate investments, while total liabilities slightly increased and total equity decreased, reflecting the net loss impact Consolidated Balance Sheets Summary (Thousands of USD) | Metric | June 30, 2025 | December 31, 2024 | Change (%) | | :----------------------- | :------------- | :--------------- | :------- | | Net Real Estate Investments | $385,299 | $389,730 | -1.1% | | Cash and Cash Equivalents | $10,621 | $10,655 | -0.3% | | Restricted Cash | $5,234 | $5,164 | +1.4% | | **Total Assets** | **$405,573** | **$415,062** | **-2.3%** | | Notes Payable, Net | $184,745 | $185,921 | -0.6% | | Credit Facility | $29,535 | $27,238 | +8.4% | | **Total Liabilities** | **$226,665** | **$225,791** | **+0.4%** | | Equity Attributable to Mobile Infrastructure Corporation Stockholders | $160,635 | $169,983 | -5.6% | | Non-Controlling Interests | $18,273 | $19,288 | -5.2% | | **Total Equity** | **$178,908** | **$189,271** | **-5.5%** | [Non-GAAP Financial Measures](index=7&type=section&id=Non-GAAP%20Financial%20Measures) [Net Operating Income (NOI)](index=7&type=section&id=Net%20Operating%20Income%20%28NOI%29) Net Operating Income (NOI), a supplemental measure of property-level operating trends, decreased by 3.5% year-over-year in Q2 2025 and 10.3% cumulatively for six months - NOI is defined as total revenue less property operating expenses and property taxes, used to evaluate property performance and operating trends[26](index=26&type=chunk) Net Operating Income (NOI) (Thousands of USD) | Metric | Q2 2025 | Q2 2024 | YoY Change (%) | | :----- | :------------- | :------------- | :----------- | | Net Operating Income | $5,435 | $5,633 | -3.5% | | H1 2025 Net Operating Income | $9,899 | $11,035 | -10.3% | [Adjusted EBITDA](index=7&type=section&id=Adjusted%20EBITDA) Adjusted EBITDA, excluding interest, taxes, depreciation, amortization, and other non-recurring items, decreased by 5.6% year-over-year in Q2 2025 and 12.9% cumulatively for six months - Adjusted EBITDA reflects net income (loss) excluding specific items such as interest expense, depreciation and amortization, provision for income taxes, and share-based compensation expense[27](index=27&type=chunk)[28](index=28&type=chunk) Adjusted EBITDA (Thousands of USD) | Metric | Q2 2025 | Q2 2024 | YoY Change (%) | | :----- | :------------- | :------------- | :----------- | | Adjusted EBITDA | $3,846 | $4,074 | -5.6% | | H1 2025 Adjusted EBITDA | $6,595 | $7,569 | -12.9% | [Net Asset Value (NAV)](index=9&type=section&id=Net%20Asset%20Value%20%28NAV%29) As of June 30, 2024, the company's fully diluted NAV per share was **$7.25**, based on a 4.0% implied capitalization rate, with annual NAV updates planned Net Asset Value Estimation as of June 30, 2024 (Thousands of USD) | Metric | Estimated Value | | :--------------------------- | :--------- | | Real Estate Investments | $546,130 | | Cash and Restricted Cash | $13,314 | | Other Assets | $7,647 | | **Total Assets** | **$567,091** | | Notes Payable and Revolving Credit Facility, Net (at Fair Value) | $179,601 | | Accrued Preferred Dividends | $9,864 | | Other Liabilities | $11,758 | | **Total Liabilities** | **$201,223** | | Preferred Stock | $33,782 | | **Total Estimated Net Asset Value** | **$332,086** | | Fully Diluted Shares Outstanding | 45,820,367 | | **Fully Diluted Net Asset Value Per Share** | **$7.25** | - The estimated value is based on applying a **4.0%** implied capitalization rate to the trailing twelve months Net Operating Income (TTM NOI) of properties owned as of June 30, 2024[31](index=31&type=chunk) - The company expects to update its NAV as of December 31, 2025, and annually thereafter[31](index=31&type=chunk) - NAV is not a GAAP measure, and its valuation is based on numerous assumptions, estimates, forecasts, and judgments that may prove inaccurate or incomplete over time[33](index=33&type=chunk) [Corporate Information](index=3&type=section&id=Corporate%20Information) [About Mobile Infrastructure Corporation](index=4&type=section&id=About%20Mobile%20Infrastructure%20Corporation) Mobile Infrastructure Corporation, a Maryland company, owns a diversified portfolio of 40 parking facilities across the US, comprising 15,100 parking spaces, approximately 5.2 million square feet of parking, and 200,000 square feet of retail/commercial space - The company owns 40 parking facilities in 20 different markets across the United States, totaling **15,100** parking spaces and approximately **5.2 million** square feet of parking space[20](index=20&type=chunk) - The company also owns approximately **200,000** square feet of retail/commercial space adjacent to its parking facilities[20](index=20&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements based on current expectations and assumptions, involving numerous risks and uncertainties, where actual results may differ materially due to factors like competition, financing ability, and economic conditions - Statements in this press release that are not historical facts are forward-looking statements, including those regarding Net Operating Income and revenue projections, economic performance trends, and the impact of strategic model changes[17](index=17&type=chunk) - Forward-looking statements are based on the company's current expectations, plans, estimates, assumptions, and beliefs, involving numerous risks and uncertainties, and actual results may differ materially[18](index=18&type=chunk) - Factors that could materially and adversely affect operations and future prospects include, but are not limited to: the company potentially continuing to incur losses, inability to implement investment strategies, intense competition, and inability to obtain attractive financing[18](index=18&type=chunk) - The company undertakes no obligation to publicly update or revise any forward-looking statements after the date of this press release, and investors should not place undue reliance on these statements[19](index=19&type=chunk) [Investor Relations & Contact](index=3&type=section&id=Investor%20Relations%20%26%20Contact) The company will host a conference call on August 12, 2025, to discuss Q2 results, offering registration and webcast options, and providing investor contact details - The company will host a conference call on August 12, 2025, at 4:30 PM ET to discuss Q2 2025 results[15](index=15&type=chunk) - Participants can register to receive dial-in numbers and a PIN, or access a live webcast via the investor relations section of the company's website[15](index=15&type=chunk) - A replay of the webcast will be available for one year in the 'News & Events' section of the investor relations website[16](index=16&type=chunk) - Investor contacts: David Gold, Lynn Morgen, email: beepir@advisiry.com, phone: (212) 750-5800[21](index=21&type=chunk)
FIFTH WALL(FWAC) - 2025 Q2 - Quarterly Results
2025-08-12 20:15
Mobile Infrastructure Reports Second Quarter 2025 Financial Results —Higher Contract Parking Volumes Reflect Positive Secular Growth Trends— Exhibit 99.1 —Advancing Non-Core Asset Divestiture Strategy— —Conference Call Will be Held Today at 4:30 PM ET— CINCINNATI—(BUSINESSWIRE)—Mobile Infrastructure Corporation (Nasdaq: BEEP), ("Mobile", "Mobile Infrastructure" or the "Company"), owners of a diversified portfolio of parking assets throughout the United States, today reported results for the second quarter e ...
stellation Acquisition I(CSTA) - 2025 Q2 - Quarterly Report
2025-08-12 20:15
☒ 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 For the transition period from to . Commission File Number: 001-39945 CONSTELLATION ACQUISITION CORP I (Exact name of registrant as specified in its charter) | Cayman Islands | 98-1574835 | | --- | --- ...
Generation Bio(GBIO) - 2025 Q2 - Quarterly Report
2025-08-12 20:15
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 For the transition period from to Commission File Number: 001-39319 GENERATION BIO CO. (Exact name of registrant as specified in its charter) Delaware 81-4301284 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification Number) 301 Binne ...
Kindercare Learning Companies, Inc.(KLC) - 2025 Q2 - Quarterly Results
2025-08-12 20:15
Exhibit 99.1 "Our second quarter financial results reflect continued revenue growth and the resilience of our business, even as enrollment trends turned softer than anticipated late in the quarter," said Paul Thompson, KinderCare's Chief Executive Officer. "Despite our second quarter occupancy being similar to pre-pandemic levels at 71%, we are intently focused on initiatives to improve occupancy. Our investments into digital tools and focused engagement are addressing market specific needs within our footp ...
Hoth Therapeutics(HOTH) - 2025 Q2 - Quarterly Report
2025-08-12 20:15
[PART I - FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This part presents the unaudited condensed consolidated financial statements and management's analysis for Q2 2025 and FY 2024 [ITEM 1. Financial Statements](index=6&type=page&id=ITEM%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements of Hoth Therapeutics, Inc. for the periods ended June 30, 2025, and December 31, 2024, including balance sheets, statements of operations and comprehensive loss, statements of changes in stockholders' equity, and statements of cash flows, along with detailed notes explaining the company's organization, accounting policies, license agreements, fair value measurements, stockholders' equity, commitments, and subsequent events [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20(Unaudited)%20and%20December%2031%2C%202024) This section details the company's financial position, including assets, liabilities, and equity, for June 30, 2025, and December 31, 2024 Condensed Consolidated Balance Sheets (Unaudited) | ASSETS | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $9,014,108 | $7,038,923 | | Prepaid expenses and other current assets | $1,038,794 | $605,948 | | Total Current Assets | $10,052,902 | $7,644,871 | | Total Non-Current Assets | $54,900 | $67,894 | | **Total Assets** | **$10,107,802** | **$7,712,765** | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Accounts payable | $75,510 | $412,071 | | Accrued expenses | $267,794 | $390,760 | | Operating lease liability, current portion | $21,326 | $28,366 | | Total Current Liabilities | $364,630 | $831,197 | | Total Long-Term Liabilities | $- | $2,709 | | **Total Liabilities** | **$364,630** | **$833,906** | | Total Stockholders' Equity | $9,743,172 | $6,878,859 | | **Total Liabilities and Stockholders' Equity** | **$10,107,802** | **$7,712,765** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024%20(Unaudited)) This section outlines the company's financial performance, including revenues, expenses, and net loss for Q2 2025 and 2024 Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) | 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 | | :------------------------------------ | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Net Revenues | $- | $- | $- | $- | | Research and development expenses | $1,039,713 | $644,025 | $2,998,315 | $1,215,667 | | General and administrative expenses | $1,159,936 | $1,079,504 | $2,677,351 | $2,667,766 | | Total operating expenses | $2,199,649 | $1,723,529 | $5,675,666 | $3,883,433 | | Loss from operations | $(2,199,649) | $(1,723,529) | $(5,675,666) | $(3,883,433) | | Total other income, net | $173 | $13,365 | $354 | $26,740 | | **Net Loss** | **$(2,199,476)** | **$(1,710,164)** | **$(5,675,312)** | **$(3,856,693)** | | Net Loss Per Common Share (Basic and diluted) | $(0.17) | $(0.25) | $(0.44) | $(0.68) | | Weighted Average Number of Common Shares Outstanding (Basic and diluted) | 13,180,243 | 6,876,331 | 12,959,901 | 5,637,621 | | Foreign currency translation adjustment | $3,478 | $1,634 | $2,981 | $(4,134) | | Total comprehensive loss | $(2,195,998) | $(1,708,530) | $(5,672,331) | $(3,860,827) | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024%20(Unaudited)) This section details changes in equity, reflecting net loss, stock issuance, and warrant exercises for Q2 2025 and 2024 - Total Stockholders' Equity increased from **$6,878,859** as of December 31, 2024, to **$9,743,172** as of June 30, 2025, primarily driven by common shares issued for warrant exercise (**$5,625,000**), stock-based compensation (**$219,929**), common stock issued for cash (**$1,441,964**), and common stock issued for patent (**$850,500**), partially offset by a net loss of **$(5,675,312)**[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024%20(Unaudited)) This section reports cash flows from operating, investing, and financing activities for the six months ended June 30, 2025, and 2024 Condensed Consolidated Statements of Cash Flows (Unaudited) | Cash Flow from Operating Activities | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :---------------------------------- | :------------------------------- | :------------------------------- | | Net loss | $(5,675,312) | $(3,856,693) | | Research and development-acquired patent, expensed | $850,500 | $- | | Stock-based compensation | $219,929 | $520,404 | | Stock-based professional fees | $55,525 | $- | | Change in fair value of investment in joint ventures | $- | $581 | | Lease costs | $3,245 | $- | | Prepaid expenses and other current assets | $(155,221) | $19,089 | | Accounts payable and accrued expenses | $(459,527) | $938 | | **NET CASH USED IN OPERATING ACTIVITIES** | **$(5,160,861)** | **$(3,315,681)** | | **CASH FLOWS FROM FINANCING ACTIVITIES:** | | | | Proceeds from issuance common stock, net of offering costs | $1,508,065 | $- | | Proceeds from exercise of warrants | $5,625,000 | $3,682,300 | | **NET CASH PROVIDED BY FINANCING ACTIVITIES** | **$7,133,065** | **$3,682,300** | | **NET INCREASE IN CASH AND CASH EQUIVALENTS** | **$1,972,204** | **$366,619** | | Effect of exchange rate changes on cash and cash equivalents | $2,981 | $(4,134) | | CASH AND CASH EQUIVALENTS - beginning of period | $7,038,923 | $9,292,352 | | **CASH AND CASH EQUIVALENTS - end of period** | **$9,014,108** | **$9,654,837** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide essential context and detailed breakdowns for the unaudited condensed consolidated financial statements, covering the company's business operations, significant accounting policies, specific financial instruments, equity changes, and contractual obligations [NOTE 1 – Organization and Description of Business Operations](index=11&type=section&id=NOTE%201%20%E2%80%93%20Organization%20and%20Description%20of%20Business%20Operations) Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs, with several product candidates in development. The company has incurred significant losses and negative cash flows, holding an accumulated deficit of $66.1 million and $9.0 million in cash as of June 30, 2025. It relies on equity sales for funding and anticipates needing additional capital for its long-term business plan, including an At The Market (ATM) offering agreement to sell up to $7.7 million in common stock - Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing therapies for unmet medical needs, including HT-001 (cancer drug side effects), HT-KIT (mast-cell derived cancers), HT-ALZ (Alzheimer's), BioLexa (atopic dermatitis), HT-004 (asthma/allergies), and HT-VA (obesity)[22](index=22&type=chunk) Financial Position (June 30, 2025) | Metric | Amount ($ million) | | :------------------ | :------------- | | Accumulated Deficit | $(66.1) million | | Cash and Cash Equivalents | $9.0 million | - The company has an At The Market (ATM) Offering Agreement to sell up to **$7,700,000** of common stock, with approximately **$2.8 million** sold as of August 12, 2025. This is a key part of its capital raising strategy[26](index=26&type=chunk) [NOTE 2 – Summary of Significant Accounting Policies](index=12&type=section&id=NOTE%202%20%E2%80%93%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the company's significant accounting policies, including the basis of presentation, use of estimates, cash and cash equivalents, fair value measurements (Level 1, 2, 3 hierarchy), lease accounting, investment in joint ventures, research and development costs (expensed as incurred), stock-based compensation valuation (Black-Scholes model), income taxes, net loss per share, warrant classification, foreign currency translation, and segment reporting (single operating segment). No material changes to previously disclosed accounting policies were reported - No material changes to the Company's significant accounting policies were reported compared to the Annual Report on Form 10-K for the fiscal year ended December 31, 2024[30](index=30&type=chunk) Cash and Cash Equivalents | Date | Amount ($) | | :---------------- | :----------- | | June 30, 2025 | $9,014,108 | | December 31, 2024 | $7,038,923 | - The Company operates as a single operating segment, focusing on developing new generation therapies, with the CEO identified as the chief operating decision maker[56](index=56&type=chunk) [NOTE 3 – License Agreements and Acquired Patent Applications](index=18&type=section&id=NOTE%203%20%E2%80%93%20License%20Agreements%20and%20Acquired%20Patent%20Applications) The company incurred expenses for license fees from The George Washington University, North Carolina State University, and the University of Cincinnati. A significant event in 2025 was the acquisition of patent applications from Med30, LLC for $1,250,500 (cash and common stock), which was expensed immediately as in-process research and development (IPRD) due to no alternative future use Research and Development Expenses for Licenses and Patent Applications | Source | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | The George Washington University | $1,250 | $8,597 | $2,500 | $9,847 | | North Carolina State University | $938 | $1,563 | $1,875 | $3,125 | | University of Cincinnati | $2,708 | $417 | $3,333 | $417 | | Patent applications acquired | $— | $— | $1,250,500 | $— | | **Total** | **$4,896** | **$10,577** | **$1,258,208** | **$13,389** | - On January 13, 2025, the Company acquired certain patent applications from Med30, LLC for an aggregate purchase price of **$1,250,500**, consisting of **$400,000** cash and **450,000 shares** of common stock (fair value **$850,500**). This was expensed immediately as in-process research and development (IPRD) as it had no alternative future use[64](index=64&type=chunk) [NOTE 4 – Fair Value of Financial Assets and Liabilities](index=19&type=section&id=NOTE%204%20%E2%80%93%20Fair%20Value%20of%20Financial%20Assets%20and%20Liabilities) The company measures its investment in joint ventures at fair value using Level 3 inputs, which involve significant unobservable inputs. As of June 30, 2025, and December 31, 2024, the investment in joint ventures (Zylö Therapeutics and Atticus Pharma) was valued at $36,819, with no change in fair value during the six months ended June 30, 2025 Fair Value of Financial Assets (Investment in Joint Ventures) | Date | Total at Fair Value (Level 3) ($) | | :---------------- | :---------------------------- | | June 30, 2025 | $36,819 | | December 31, 2024 | $36,819 | - The investment in joint ventures, specifically Zylö Therapeutics and Atticus Pharma, is measured at fair value using Level 3 inputs, which include probabilities of scenarios, timing of occurrence, future valuation, and risk-adjusted discount rates[73](index=73&type=chunk)[69](index=69&type=chunk) - There was **no change** in the fair value of investment in joint ventures for the three and six months ended June 30, 2025, compared to a **$(581) change** for the six months ended June 30, 2024[66](index=66&type=chunk)[68](index=68&type=chunk) [NOTE 5 – Stockholders' Equity](index=21&type=section&id=NOTE%205%20%E2%80%93%20Stockholders'%20Equity) This note details the company's capital structure, including authorized preferred stock (Series A and B, none outstanding), common stock, and warrant activity. Significant events include the exercise of 3,750,000 April 2024 Inducement Warrants for $5,625,000 cash in January 2025, and the issuance of 300,000 warrants for investor relations services in June 2025. The company also issued 450,000 common shares for patent acquisition and 927,968 shares through an ATM agreement in Q1 2025. Equity incentive plans (2018 and 2022) saw increases in reserved shares and new stock option grants, leading to stock-based compensation expenses of $275,454 for the six months ended June 30, 2025 - As of June 30, 2025, the Company had **13,234,027 common shares** issued and outstanding, an increase from **8,042,747 shares** as of December 31, 2024[13](index=13&type=chunk) - On January 7, 2025, **3,750,000 common shares** were issued from the exercise of April 2024 Inducement Warrants, generating **$5,625,000** in cash proceeds[86](index=86&type=chunk)[90](index=90&type=chunk) - On June 4, 2025, the Company issued warrants to purchase **300,000 common shares** at an exercise price of **$1.00** for investor relations services, with a grant date fair value of **$333,150**[87](index=87&type=chunk) Stock-Based Compensation Expense | Period | 2025 (Six Months) ($) | 2024 (Six Months) ($) | | :-------------------------------- | :---------------- | :---------------- | | Employee stock option awards | $219,929 | $512,685 | | Non-employee restricted stock awards | $— | $1,330 | | Non-employee stock warrant awards | $55,525 | $6,389 | | **Total Stock-Based Compensation** | **$275,454** | **$520,404** | [NOTE 6 – Commitments and Contingencies](index=29&type=section&id=NOTE%206%20%E2%80%93%20Commitments%20and%20Contingencies) The company's commitments primarily involve an office lease. A new 14-month lease agreement was entered into in December 2024, expiring February 28, 2026, with a monthly base rent of $2,732 from March 2025. The ROU asset and lease liability were adjusted accordingly. Additionally, the exclusive license agreement with Isoprene Pharmaceutical, Inc. was terminated on March 23, 2025 - The Company entered into a new office lease agreement in December 2024, effective December 20, 2024, for a **14-month term** expiring February 28, 2026, with a monthly base rent of **$2,732** from March 1, 2025[108](index=108&type=chunk) Operating Lease ROU Asset and Liability | Metric | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------------------- | :------------ | :---------------- | | Office lease ROU asset, net | $18,081 | $31,075 | | Current portion of operating lease liability | $21,326 | $28,366 | | Long-term portion of operating lease liability | $- | $2,709 | | **Total operating lease liability** | **$21,326** | **$31,075** | - The exclusive license agreement with Isoprene Pharmaceutical, Inc. was terminated on March 23, 2025[113](index=113&type=chunk) [NOTE 7 – Subsequent Events](index=30&type=section&id=NOTE%207%20%E2%80%93%20Subsequent%20Events) Subsequent to the reporting period, on May 9, 2025, the board of directors approved an increase of 2,000,000 shares reserved for issuance under the Amended and Restated 2022 Plan, which was subsequently approved by shareholders on August 5, 2025 - On May 9, 2025, the board approved an increase of **2,000,000 shares** for the Amended and Restated 2022 Omnibus Equity Incentive Plan, approved by shareholders on August 5, 2025[115](index=115&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=page&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial performance, liquidity, and capital resources for the three and six months ended June 30, 2025, compared to the prior year. It highlights significant increases in research and development expenses, particularly due to patent acquisition, and discusses the company's ongoing need for additional funding to support its clinical development programs [Overview](index=31&type=section&id=Overview) Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs, with a pipeline of product candidates targeting various conditions including cancer treatment side effects, mast-cell derived cancers, Alzheimer's, atopic dermatitis, asthma/allergies, and obesity - Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs, with product candidates including HT-001, HT-KIT, HT-ALZ, BioLexa, HT-004, and HT-VA[117](index=117&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) The company experienced a significant increase in research and development expenses for both the three and six months ended June 30, 2025, primarily due to increased clinical activities and a substantial patent application acquisition. General and administrative expenses remained relatively stable, while net losses widened for both periods [Three Months Ended June 30, 2025 vs. 2024](index=31&type=section&id=Comparison%20of%20Our%20Results%20of%20Operations%20for%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) For the three months ended June 30, 2025, research and development expenses increased by 61.4% to $1.04 million, driven by HT-001 and HT-KIT activities. General and administrative expenses rose by 7.5% to $1.16 million, mainly due to higher professional and consulting fees. The net loss increased by 28.6% to $2.20 million Operating Costs and Expenses (Three Months Ended June 30) | Expense Category | 2025 ($) | 2024 ($) | Change ($) | Change (%) | | :-------------------------------- | :----------- | :----------- | :----------- | :--------- | | Research and development expenses | $1,039,713 | $644,025 | $395,688 | 61.4% | | General and administrative expenses | $1,159,936 | $1,079,504 | $80,432 | 7.5% | | **Total operating expenses** | **$2,199,649** | **$1,723,529** | **$476,120** | **27.6%** | | **Net Loss** | **$(2,199,476)** | **$(1,710,164)** | **$(489,312)** | **28.6%** | | Net Loss Per Common Share (Basic and diluted) | $(0.17) | $(0.25) | $0.08 | -32.0% | - Increase in General and Administrative Expenses (3 months): Primarily attributed to an increase in professional and consulting expenses of approximately **$178,000** (legal, accounting, stock-based professional fees, directors fees), offset by decreases in compensation and other general and administrative expenses[121](index=121&type=chunk) [Six Months Ended June 30, 2025 vs. 2024](index=33&type=section&id=Comparison%20of%20Our%20Results%20of%20Operations%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) For the six months ended June 30, 2025, research and development expenses surged by 146.6% to $3.00 million, largely due to a $1.3 million expense for acquired patent applications. General and administrative expenses remained stable at $2.68 million. The net loss increased by 47.1% to $5.68 million Operating Costs and Expenses (Six Months Ended June 30) | Expense Category | 2025 ($) | 2024 ($) | Change ($) | Change (%) | | :-------------------------------- | :----------- | :----------- | :----------- | :--------- | | Research and development expenses | $2,998,315 | $1,215,667 | $1,782,648 | 146.6% | | General and administrative expenses | $2,677,351 | $2,667,766 | $9,585 | 0.4% | | **Total operating expenses** | **$5,675,666** | **$3,883,433** | **$1,792,233** | **46.1%** | | **Net Loss** | **$(5,675,312)** | **$(3,856,693)** | **$(1,818,619)** | **47.1%** | | Net Loss Per Common Share (Basic and diluted) | $(0.44) | $(0.68) | $0.24 | -35.3% | - Increase in Research and Development Expenses (6 months): Primarily due to approximately **$1.3 million** in-process research and development expenses from acquired patent applications, and increased manufacturing and clinical activities for HT-001 and HT-KIT[125](index=125&type=chunk) - General and Administrative Expenses (6 months): Increased by approximately **$9,000**, driven by a **$295,000 increase** in professional and consulting expenses, offset by a **$209,000 decrease** in compensation and related expenses[129](index=129&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) Hoth Therapeutics, Inc. has historically funded its operations through equity and debt sales. As of June 30, 2025, the company had $9.0 million in cash and cash equivalents, $9.7 million in working capital, and an accumulated deficit of $66.1 million. Net cash used in operating activities was $5.2 million for the six months ended June 30, 2025, while net cash provided by financing activities was $7.1 million, primarily from common stock issuance and warrant exercises. The company believes its current cash is sufficient for at least 12 months but will require additional funding for future clinical and pre-clinical activities Financial Position (June 30, 2025) | Metric | Amount ($ million) | | :------------------------ | :------------- | | Cash and cash equivalents | $9.0 million | | Working capital | $9.7 million | | Accumulated deficit | $66.1 million | Cash Flows (Six Months Ended June 30) | Activity | 2025 ($ million) | 2024 ($ million) | | :-------------------------------- | :----------- | :----------- | | Net cash used in operating activities | $(5.2) million | $(3.3) million | | Net cash provided by financing activities | $7.1 million | $3.7 million | - The company believes its existing cash as of June 30, 2025, is sufficient to fund operations for at least **12 months**, but significant additional funding will be necessary for future clinical and pre-clinical activities[133](index=133&type=chunk)[138](index=138&type=chunk) [Critical Accounting Estimates](index=36&type=section&id=Critical%20Accounting%20Estimates) The company's critical accounting estimates involve significant judgment and assumptions, particularly in valuing stock-based compensation using the Black-Scholes option pricing model and in accounting for income taxes, including deferred tax assets and valuation allowances - Critical accounting estimates include stock-based compensation (fair value estimation using Black-Scholes model with assumptions for expected term, volatility, risk-free rate, and dividend) and income taxes (deferred tax assets and valuation allowances)[145](index=145&type=chunk)[146](index=146&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk)[152](index=152&type=chunk)[153](index=153&type=chunk) [Recently Adopted Accounting Standards](index=37&type=section&id=Recently%20Adopted%20Accounting%20Standards) The company adopted ASU 2023-07 (Segment Reporting) on January 1, 2024. It does not expect ASU 2024-03 (Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures), effective for fiscal years beginning after December 15, 2026, to have a material impact on its financial statements - The Company adopted ASU 2023-07, Segment Reporting, on January 1, 2024[56](index=56&type=chunk) - The Company does not expect ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures, to have a material impact on its unaudited condensed consolidated financial statements upon its effective date (fiscal years beginning after December 15, 2026)[57](index=57&type=chunk)[154](index=154&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=page&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," Hoth Therapeutics, Inc. is exempt from providing quantitative and qualitative disclosures about market risk in this Quarterly Report on Form 10-Q - The Company is **not required** to provide quantitative and qualitative disclosures about market risk as it is a "smaller reporting company"[155](index=155&type=chunk) [ITEM 4. Controls and Procedures](index=38&type=page&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were not effective as of June 30, 2025, due to a material weakness identified in the proper classification of prepaid expenses and other current assets and research and development expenses. A remediation plan is being implemented to enhance review procedures over significant contracts and strengthen the overall review process - Disclosure controls and procedures were **not effective** as of June 30, 2025[156](index=156&type=chunk) - A material weakness was identified related to the proper classification of prepaid expenses and other current assets and research and development expenses[157](index=157&type=chunk) - Remediation plan includes enhancing review procedures over significant contracts with research and clinical studies organizations and strengthening the review process[158](index=158&type=chunk)[160](index=160&type=chunk) [PART II - OTHER INFORMATION](index=39&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This part provides additional information including legal proceedings, risk factors, equity sales, and exhibits [ITEM 1. Legal Proceedings](index=39&type=page&id=ITEM%201.%20Legal%20Proceedings) Hoth Therapeutics, Inc. is not currently involved in any material legal proceedings and is unaware of any pending or threatened legal actions that could significantly impact its business, operating results, cash flows, or financial condition - The Company is not currently a party to any material legal proceedings and is not aware of any pending or threatened legal proceeding that could have a material adverse effect on its business, operating results, cash flows or financial condition[162](index=162&type=chunk) [ITEM 1A. Risk Factors](index=39&type=page&id=ITEM%201A.%20Risk%20Factors) The company refers to its Annual Report on Form 10-K for a comprehensive list of risk factors, supplementing it with new risks related to current and future legislative and regulatory reforms in the healthcare system. These reforms, including the Medicare Modernization Act, the Affordable Care Act, and the "One Big Beautiful Bill Act," could increase costs, affect product pricing, and limit market access for its product candidates, potentially harming its business and financial results - Risk factors from the Annual Report on Form 10-K for the year ended December 31, 2024, are incorporated by reference[163](index=163&type=chunk) - New risk factors include the impact of current and future legislative and regulatory reforms in the healthcare system (e.g., Medicare Modernization Act, Affordable Care Act, "One Big Beautiful Bill Act") which could increase costs, affect product pricing, and limit market access for product candidates[164](index=164&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk)[168](index=168&type=chunk)[169](index=169&type=chunk)[170](index=170&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=page&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) On June 4, 2025, Hoth Therapeutics, Inc. issued warrants to purchase up to 300,000 shares of its common stock to a consultant for investor relations services. These warrants, with an exercise price of $1.00 per share and expiring on June 4, 2027, were issued under the exemption from registration provided by Section 4(a)(2) of the Securities Act - On June 4, 2025, the Company issued warrants to purchase up to **300,000 shares** of common stock at an exercise price of **$1.00 per share** to a consultant for investor relations services, expiring on June 4, 2027. These were issued under the Section 4(a)(2) exemption from registration[171](index=171&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=40&type=page&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the fiscal quarter ended June 30, 2025 - **No defaults** upon senior securities were reported[172](index=172&type=chunk) [ITEM 5. Other Information](index=40&type=page&id=ITEM%205.%20Other%20Information) During the fiscal quarter ended June 30, 2025, none of the company's directors or executive officers adopted or terminated any Rule 10b5-1 trading plans - **No Rule 10b5-1 trading plans** were adopted or terminated by directors or executive officers during the fiscal quarter ended June 30, 2025[173](index=173&type=chunk) [ITEM 6. Exhibits](index=41&type=page&id=ITEM%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including various certifications from the Principal Executive Officer and Principal Financial Officer, as well as Inline XBRL documents for financial data - Exhibits include certifications (**31.1, 31.2, 32.1, 32.2**) from the Principal Executive Officer and Principal Financial Officer, and Inline XBRL documents (Instance, Schema, Calculation, Definition, Label, Presentation Linkbase Documents, and Cover Page Interactive Data File)[174](index=174&type=chunk) [SIGNATURES](index=42&type=section&id=SIGNATURES) This section contains the official signatures of the company's authorized officers, certifying report accuracy - The report was signed on August 12, 2025, by Robb Knie, Chief Executive Officer, and David Briones, Chief Financial Officer, on behalf of Hoth Therapeutics, Inc[180](index=180&type=chunk)
DiaMedica Therapeutics(DMAC) - 2025 Q2 - Quarterly Results
2025-08-12 20:15
[Executive Summary & Business Update](index=1&type=section&id=1.%20Executive%20Summary%20%26%20Business%20Update) DiaMedica Therapeutics Inc. provides an overview of its clinical-stage biopharmaceutical focus on ischemic diseases, highlighting recent positive clinical results and corporate milestones [Company Overview and Strategic Direction](index=1&type=section&id=1.1%20Company%20Overview%20and%20Strategic%20Direction) DiaMedica Therapeutics Inc. is a clinical-stage biopharmaceutical company developing novel treatments for ischemic diseases, with positive interim results for DM199 in preeclampsia - DiaMedica Therapeutics Inc. is a **clinical-stage biopharmaceutical company** focused on developing novel treatments for **preeclampsia, fetal growth restriction, and acute ischemic stroke**[2](index=2&type=chunk)[3](index=3&type=chunk)[9](index=9&type=chunk) - The lead candidate, **DM199**, is the first pharmaceutically active recombinant (synthetic) form of the **KLK1 protein**[3](index=3&type=chunk)[9](index=9&type=chunk) - CEO Rick Pauls noted **positive interim results** from Part 1a of the **Phase 2 study** evaluating **DM199** in preeclampsia and a **$30M capital raise**, expressing eagerness to advance the candidate for ischemic diseases[3](index=3&type=chunk) [Recent Corporate and Clinical Highlights](index=1&type=section&id=1.2%20Recent%20Corporate%20and%20Clinical%20Highlights) DiaMedica achieved key milestones, including positive preeclampsia trial results, progress in AIS trial, a $30.1 million private placement, and a new CMO appointment [Preeclampsia Phase 2 Part 1a Interim Results](index=1&type=section&id=1.2.1%20Preeclampsia%20Phase%202%20Part%201a%20Interim%20Results) Positive interim results from the Phase 2 Part 1a trial of DM199 for preeclampsia demonstrated safety and efficacy - **Positive interim results** (n=28) from Part 1a of the investigator-sponsored **Phase 2 trial** of **DM199** for preeclampsia were reported in July 2025, achieving pre-specified **safety and efficacy endpoints**[4](index=4&type=chunk) - **DM199** demonstrated **highly statistically significant** and **clinically meaningful reductions** in systolic and diastolic **blood pressure** for combined cohorts 6-9[4](index=4&type=chunk)[5](index=5&type=chunk) - **DM199** appeared **safe and well tolerated** with **no evidence of placental transfer** for any dose[4](index=4&type=chunk)[5](index=5&type=chunk) - A **highly statistically significant reduction** in **uterine artery pulsatility index** suggested an **improvement in uterine artery blood flow and placental perfusion**[4](index=4&type=chunk) [Acute Ischemic Stroke (AIS) ReMEDy2 Phase 2/3 Trial Progress](index=1&type=section&id=1.2.2%20Acute%20Ischemic%20Stroke%20%28AIS%29%20ReMEDy2%20Phase%202%2F3%20Trial%20Progress) Enrollment for the ReMEDy2 Phase 2/3 trial for Acute Ischemic Stroke is progressing, with interim analysis expected in Q2 2026 - **Enrollment** in the Company's **Phase 2/3 ReMEDy2 trial** for **Acute Ischemic Stroke (AIS)** is progressing[5](index=5&type=chunk)[7](index=7&type=chunk) - **Interim analysis** on the **first 200 patients** in the ReMEDy2 trial is expected to be completed in the **second quarter of 2026**[5](index=5&type=chunk)[7](index=7&type=chunk) [Key Corporate Milestones](index=2&type=section&id=1.2.3%20Key%20Corporate%20Milestones) Recent corporate milestones include a $30.1 million private placement, Russell Index inclusion, and a new Chief Medical Officer appointment - Completed a **$30.1 million private placement** in **July 2025**, extending **cash runway into H2 2027**[5](index=5&type=chunk)[7](index=7&type=chunk) - Included in the **Russell 2000® and 3000® Indexes** in **June 2025**[5](index=5&type=chunk)[7](index=7&type=chunk) - Appointed **Julie Krop, MD**, as **Chief Medical Officer** in **August 2025**, bringing over 20 years of experience in therapeutic and orphan indications[5](index=5&type=chunk)[7](index=7&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=2.%20Second%20Quarter%202025%20Financial%20Results) This section details DiaMedica's second quarter 2025 financial performance, including cash position, operating expenses, net loss, and comprehensive financial statements [Financial Highlights](index=2&type=section&id=2.1%20Financial%20Highlights) DiaMedica's proforma cash balance reached **$60 million** after a **$30.1 million** private placement, extending its cash runway despite increased operating expenses and net loss [Capital Raise and Cash Position](index=2&type=section&id=2.1.1%20Capital%20Raise%20and%20Cash%20Position) A **$30.1 million** private placement boosted the proforma cash balance to **$60 million**, extending the operational runway into H2 2027 - A **$30.1 million private placement** in July 2025 increased the **proforma cash balance to approximately $60 million**[7](index=7&type=chunk) - The capital raised is expected to **fund operations for over two years**, supporting upcoming milestones and planned clinical studies into the **second half of 2027**[7](index=7&type=chunk) Cash Position Overview | Metric | June 30, 2025 | December 31, 2024 | Change | | :------------------------------------ | :------------ | :------------------ | :----- | | Cash, cash equivalents and short-term investments | $30.0 million | $44.1 million | -$14.1 million | [Operating Expenses Analysis](index=2&type=section&id=2.1.2%20Operating%20Expenses%20Analysis) Research and development and general and administrative expenses increased year-over-year, driven by clinical trial expansion and personnel costs Operating Expenses (in thousands) | Expense Category | Q2 2025 (3 months) | Q2 2024 (3 months) | YoY Change | H1 2025 (6 months) | H1 2024 (6 months) | YoY Change | | :----------------------- | :----------------- | :----------------- | :--------- | :----------------- | :----------------- | :--------- | | Research and development | $5,822 | $3,928 | +$1,894 | $11,478 | $7,604 | +$3,874 | | General and administrative | $2,185 | $1,710 | +$475 | $4,673 | $3,775 | +$898 | - The **increase in R&D expenses** was primarily due to the continued progress and global expansion of the **ReMEDy2 clinical trial** and the **expansion of the clinical team**[7](index=7&type=chunk) - The **increase in G&A expenses** resulted primarily from additional **non-cash share-based compensation** and **increased personnel costs**[10](index=10&type=chunk) [Net Loss Overview](index=3&type=section&id=2.1.3%20Net%20Loss%20Overview) The company reported an increased net loss for both the three and six months ended June 30, 2025, impacting basic and diluted net loss per share Net Loss (in thousands) | Metric | Q2 2025 (3 months) | Q2 2024 (3 months) | YoY Change | H1 2025 (6 months) | H1 2024 (6 months) | YoY Change | | :------- | :----------------- | :----------------- | :--------- | :----------------- | :----------------- | :--------- | | Net Loss | $(7,699) | $(5,119) | -$(2,580) | $(15,406) | $(10,270) | -$(5,136) | Basic and Diluted Net Loss Per Share | Metric | Q2 2025 (3 months) | Q2 2024 (3 months) | H1 2025 (6 months) | H1 2024 (6 months) | | :----------------------------- | :----------------- | :----------------- | :----------------- | :----------------- | | Basic and diluted net loss per share | $(0.18) | $(0.13) | $(0.36) | $(0.27) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=2.2%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section presents unaudited condensed consolidated statements of operations and comprehensive loss for Q2 2025 and 2024, detailing expenses, income, and net loss Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts) | | | | Three Months Ended June | | Six Months Ended June | | | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | | 30, | | | 2024 | 30, | | 2024 | | | 2025 | | | | 2025 | | | | Operating expenses: | | | | | | | | | Research and development | $ | 5,822 | $ | 3,928 | $ 11,478 | $ | 7,604 | | General and administrative | | 2,185 | | 1,710 | 4,673 | | 3,775 | | Operating loss | | (8,007) | | (5,638) | (16,151) | | (11,379) | | Other income, net | | 314 | | 526 | 757 | | 1,123 | | Loss before income tax expense | | (7,693) | | (5,112) | (15,394) | | (10,256) | | Income tax expense | | (6) | | (7) | (12) | | (14) | | Net loss | | (7,699) | | (5,119) | (15,406) | | (10,270) | | Other comprehensive loss | | | | | | | | | Unrealized loss on marketable securities | | (19) | | (12) | (37) | | (57) | | Net loss and comprehensive loss | $ | (7,718) | $ | (5,131) | $ (15,443) | $ | (10,327) | | Basic and diluted net loss per share | $ | (0.18) | $ | (0.13) | $ (0.36) | $ | (0.27) | | Weighted average shares outstanding – basic and diluted | 42,957,619 | | | 38,068,378 | 42,901,093 | | 38,013,189 | [Condensed Consolidated Balance Sheets](index=6&type=section&id=2.3%20Condensed%20Consolidated%20Balance%20Sheets) This section presents unaudited condensed consolidated balance sheets, showing total assets decreased from **$46.3 million** to **$31.5 million** due to reduced marketable securities Condensed Consolidated Balance Sheets (in thousands, except share amounts) | | | June 30, 2025 | | December 31, 2024 | | :--- | :--- | :--- | :--- | :--- | | | | (unaudited) | | | | ASSETS | | | | | | Current assets: | | | | | | Cash and cash equivalents | $ | 4,109 | $ | 3,025 | | Marketable securities | | 25,929 | | 41,122 | | Prepaid expenses and other assets | | 680 | | 227 | | Deposits | | 200 | | — | | Amounts receivable | | 161 | | 236 | | Total current assets | | 31,079 | | 44,610 | | Non-current assets: | | | | | | Operating lease right-of-use asset, net | | 239 | | 279 | | Property and equipment, net | | 152 | | 148 | | Deposits | | — | | 1,308 | | Total non-current assets | | 391 | | 1,735 | | Total assets | $ | 31,470 | $ | 46,345 | | LIABILITIES AND EQUITY | | | | | | Current liabilities: | | | | | | Accounts payable | $ | 1,261 | $ | 940 | | Accrued liabilities | | 2,747 | | 4,347 | | Operating lease obligation | | 96 | | 90 | | Finance lease obligation | | 12 | | 13 | | Total current liabilities | | 4,116 | | 5,390 | | Non-current liabilities: | | | | | | Operating lease obligation | | 176 | | 225 | | Finance lease obligation | | 8 | | 12 | | Total non-current liabilities | | 184 | | 237 | | Shareholders' equity: | | | | | | Common shares, no par value; unlimited authorized; 43,072,488 and 42,818,660 | | | | | | shares issued and outstanding, as of June 30, 2025 and December 31, 2024, | | | | | | respectively | | — | | — | | Paid-in capital | | 182,592 | | 180,697 | | Accumulated other comprehensive income (loss) | | (14) | | 23 | | Accumulated deficit | | (155,408) | | (140,002) | | Total shareholders' equity | | 27,170 | | 40,718 | | Total liabilities and shareholders' equity | $ | 31,470 | $ | 46,345 | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=2.4%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section details unaudited cash flows, showing increased net cash used in operating activities to **$14.7 million** and increased net cash from investing activities to **$15.6 million** Condensed Consolidated Statements of Cash Flows (in thousands) | | | Six Months Ended June 30, | | | | :--- | :--- | :--- | :--- | :--- | | | 2025 | | | 2024 | | Cash flows from operating activities: | | | | | | Net loss | $ | (15,406) | $ | (10,270) | | Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | Share-based compensation | | 1,638 | | 931 | | Amortization of discounts on marketable securities | | (441) | | (648) | | Non-cash lease expense | | 40 | | 37 | | Depreciation | | 14 | | 18 | | Changes in operating assets and liabilities: | | | | | | Amounts receivable | | 75 | | (22) | | Prepaid expenses and other assets | | (453) | | (156) | | Deposits | | 1,108 | | (1,308) | | Accounts payable | | 321 | | (167) | | Accrued liabilities and operating lease liabilities | | (1,643) | | 413 | | Net cash used in operating activities | | (14,747) | | (11,172) | | Cash flows from investing activities: | | | | | | Purchase of marketable securities | | (16,370) | | (18,047) | | Maturities of marketable securities | | 31,967 | | 27,000 | | Purchases of property and equipment | | (18) | | (9) | | Net cash provided by investing activities | | 15,579 | | 8,944 | | Cash flows from financing activities: | | | | | | Proceeds from issuance of common shares, net of offering costs | | — | | 11,747 | | Proceed from the exercise of common stock options | | 257 | | 7 | | Principal payments on finance lease obligation | | (5) | | (3) | | Net cash provided by financing activities | | 252 | | 11,751 | | Net increase in cash and cash equivalents | | 1,084 | | 9,523 | | Cash and cash equivalents at beginning of period | | 3,025 | | 4,543 | | Cash and cash equivalents at end of period | $ | 4,109 | $ | 14,066 | | Supplemental disclosure of non-cash transactions: | | | | | | Assets acquired under financing lease | $ | — | $ | 30 | | Cash paid for income taxes | $ | 12 | $ | 14 | [Additional Information](index=1&type=section&id=3.%20Additional%20Information) This section provides supplementary information, including conference call details, company background, forward-looking statements, and contact information [Conference Call and Webcast Information](index=1&type=section&id=3.1%20Conference%20Call%20and%20Webcast%20Information) DiaMedica hosted a conference call and webcast on August 13, 2025, to discuss its business update and Q2 2025 financial results - A conference call and webcast were hosted on Wednesday, **August 13, 2025**, at **8:00 AM Eastern Time / 7:00 AM Central Time**[2](index=2&type=chunk)[5](index=5&type=chunk)[8](index=8&type=chunk) - The webcast will remain **available for playback** on the Company's website under investor relations - events and presentations for **12 months**[8](index=8&type=chunk) [About DiaMedica Therapeutics Inc.](index=3&type=section&id=3.2%20About%20DiaMedica%20Therapeutics%20Inc.) DiaMedica Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on ischemic diseases, with DM199 as its lead recombinant KLK1 protein candidate - DiaMedica Therapeutics Inc. is a **clinical-stage biopharmaceutical company**[9](index=9&type=chunk) - The company is committed to improving the lives of people suffering from **serious ischemic diseases**, focusing on **preeclampsia, fetal growth restriction, and acute ischemic stroke**[9](index=9&type=chunk) - **DM199**, the lead candidate, is the first pharmaceutically active **recombinant (synthetic) form of the KLK1 protein**[9](index=9&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=4&type=section&id=3.3%20Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This section highlights that forward-looking statements are subject to known and unknown risks and uncertainties, and the company is not obligated to update them - The press release contains **forward-looking statements** subject to **known and unknown risks, uncertainties, and other factors**[11](index=11&type=chunk) - Applicable risks include those related to **preclinical and clinical data, regulatory approvals, trial enrollment, adverse events, funding, and global supply chain issues**[11](index=11&type=chunk) - DiaMedica undertakes **no obligation to update or revise** any forward-looking statements or information, **except as required by applicable laws**[11](index=11&type=chunk) [Contact Information](index=4&type=section&id=3.4%20Contact%20Information) This section provides essential contact information for DiaMedica's Chief Financial Officer, investor relations, and media inquiries - Contact for **Chief Financial Officer**: **Scott Kellen**, Phone: (763) 496-5118, Email: skellen@diamedica.com[12](index=12&type=chunk) - Contact for **Investor Inquiries**: **Mike Moyer**, Managing Director, LifeSci Advisors, LLC, Phone: (617) 308-4306, Email: mmoyer@lifesciadvisors.com[12](index=12&type=chunk) - Contact for **Media**: **Madelin Hawtin**, LifeSci Communications, Email: mhawin@lifescicomms.com[12](index=12&type=chunk)
SmartKem, Inc.(SMTK) - 2025 Q2 - Quarterly Results
2025-08-12 20:15
Exhibit 99.1 Smartkem Reports Second Quarter 2025 Financial Results Manchester, England – Tuesday, August 12, 2025 – Smartkem (Nasdaq: SMTK), which is seeking to change the world of electronics with a new class of transistor technology, today provides a business update and reports its financial results for the three and six months ended June 30, 2025. Second quarter 2025 and recent highlights included: Second Quarter 2025 Financial Highlights: About Smartkem Smartkem is seeking to change the world of electr ...