Part I. Financial Information [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed financial statements for Thayer Ventures Acquisition Corporation II, detailing its financial position and performance [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) As of June 30, 2025, the company reported total assets of $203.1 million, liabilities of $8.5 million, and a shareholders' deficit of $7.6 million Condensed Balance Sheets | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Assets** | **$203,139,389** | **$622,778** | | Cash and securities held in Trust Account | $202,248,578 | $— | | **Total Liabilities** | **$8,522,246** | **$662,195** | | Deferred underwriting fee payable | $7,568,750 | $— | | **Class A ordinary shares subject to possible redemption** | **$202,248,578** | **$—** | | **Total Shareholders' Deficit** | **($7,631,435)** | **($39,417)** | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) For the three and six months ended June 30, 2025, the company reported net income of $490,729 and $327,628, respectively, primarily from Trust Account investments Condensed Statements of Operations | | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :--- | :--- | :--- | | General and administrative costs | $471,599 | $489,700 | | Earnings from investments held in Trust Account | $998,578 | $998,578 | | **Net income (loss)** | **$490,729** | **$327,628** | [Condensed Statements of Changes in Shareholders' (Deficit) Equity](index=6&type=section&id=Condensed%20Statements%20of%20Changes%20in%20Shareholders%27%20%28Deficit%29%20Equity) The company's total shareholders' deficit significantly increased to $7.6 million by June 30, 2025, primarily due to the accretion of Class A ordinary shares - The total shareholders' deficit grew to **$(7,631,435)** as of June 30, 2025, from **$(39,417)** at the start of the year[17](index=17&type=chunk) - A major factor in the increased deficit was the accretion of Class A ordinary shares to their redemption amount, totaling **$15,507,590**, which was charged against additional paid-in capital and accumulated deficit[17](index=17&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, financing activities provided $200.4 million, investing activities used $201.3 million, and operating activities provided $869,178, resulting in no net change in cash Cash Flows (Six Months Ended June 30, 2025) | Cash Flows (Six Months Ended June 30, 2025) | Amount | | :--- | :--- | | Net cash provided by operating activities | $869,178 | | Net cash used in investing activities | ($201,250,000) | | Net cash provided by financing activities | $200,380,822 | | **Net Change in Cash** | **$0** | [Notes to Condensed Financial Statements (Unaudited)](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements%20%28Unaudited%29) These notes provide critical context, detailing the company's formation as a blank check company, its IPO, going concern uncertainty, and related-party transactions - The company is a blank check company formed to effect a business combination and consummated its Initial Public Offering of **20,125,000 units** on May 16, 2025, generating gross proceeds of **$201,250,000**[25](index=25&type=chunk)[27](index=27&type=chunk) - The company must complete a Business Combination within **21 months** from the IPO closing, by **February 16, 2027**, or it will be required to liquidate and redeem public shares[37](index=37&type=chunk) - Management has identified substantial doubt about the company's ability to continue as a going concern due to a lack of cash, which it plans to address through a Business Combination[44](index=44&type=chunk) - The company has an agreement to pay its Sponsor **$30,000 per month** for office space and administrative services, commencing May 14, 2025[80](index=80&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and operational results, focusing on its limited activities as a blank check company and liquidity concerns [Results of Operations](index=19&type=section&id=Results%20of%20Operations) The company, having no operations or revenue, reported a net income of $327,628 for the six months ended June 30, 2025, primarily from Trust Account investments Results of Operations (Six Months Ended June 30, 2025) | Item | Six Months Ended June 30, 2025 | | :--- | :--- | | Earnings from investments held in Trust Account | $998,578 | | General and administrative costs | ($489,700) | | Share-based compensation expense | ($181,250) | | **Net Income** | **$327,628** | [Liquidity, Capital Resources and Going Concern](index=19&type=section&id=Liquidity%2C%20Capital%20Resources%20and%20Going%20Concern) The company's liquidity is primarily from its IPO and private placement, with $201.25 million in a trust account, but a lack of operating cash raises going concern uncertainty - Following the IPO and Private Placement, a total of **$201,250,000** was placed in the Trust Account[116](index=116&type=chunk)[117](index=117&type=chunk) - As of June 30, 2025, the company had **$0 cash** and was owed **$603,901** by the Sponsor[121](index=121&type=chunk) - Management identified a going concern uncertainty due to the lack of available cash, which it plans to resolve through a Business Combination[124](index=124&type=chunk) [Quantitative and Qualitative Disclosures Regarding Market Risk](index=21&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20Regarding%20Market%20Risk) As a smaller reporting company, the company is exempt from providing quantitative and qualitative disclosures about market risk - As a smaller reporting company, the company is exempt from providing quantitative and qualitative disclosures about market risk[132](index=132&type=chunk) [Controls and Procedures](index=21&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective as of the end of the reporting period, **June 30, 2025**[134](index=134&type=chunk) - No material changes to the company's internal control over financial reporting occurred during the fiscal quarter[136](index=136&type=chunk) Part II. Other Information [Legal Proceedings](index=22&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that there is no material litigation currently pending or contemplated against the company, its officers, or its directors - To the knowledge of management, there is no material litigation currently pending or contemplated against the company[138](index=138&type=chunk) [Risk Factors](index=22&type=section&id=Item%201A.%20Risk%20Factors) The company states that there have been no material changes to the risk factors previously disclosed in its final prospectus for the Initial Public Offering - There have been no material changes to the risk factors disclosed in the company's final IPO prospectus filed on **May 15, 2025**[139](index=139&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=22&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section describes the sale of 362,500 Private Placement Units to the Sponsor for $3.625 million and confirms the use of IPO proceeds, primarily for a trust account - Simultaneously with the IPO on **May 16, 2025**, the company sold **362,500 Private Placement Units** to the Sponsor at **$10.00 per unit**, generating gross proceeds of **$3,625,000**[140](index=140&type=chunk) - Following the IPO, **$201,250,000** was placed in a U.S.-based trust account, with remaining proceeds used to identify a target and fund the initial Business Combination[141](index=141&type=chunk)[142](index=142&type=chunk) [Defaults Upon Senior Securities](index=22&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[143](index=143&type=chunk) [Mine Safety Disclosures](index=22&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reports no mine safety disclosures - None[143](index=143&type=chunk) [Other Information](index=22&type=section&id=Item%205.%20Other%20Information) The company reports no other information - None[143](index=143&type=chunk) [Exhibits](index=23&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including officer certifications and XBRL data files - Exhibits filed include certifications from the Principal Executive Officer and Principal Financial Officer, as well as XBRL Instance Documents[145](index=145&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 ☐ 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: 001-42641 THAYER VENTURES ACQUISITION CORPORATION II (Exact name of registrant as specified in its charter) Cayman Islands 98-1795713 ( ...

PART I. FINANCIAL INFORMATION This section presents the company's unaudited financial statements, management's analysis, market risk disclosures, and internal controls [Item 1. Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The company's financial statements show a significant net loss, decreased cash and equity, and a 'going concern' warning due to funding needs [Condensed Balance Sheets](index=7&type=section&id=Condensed%20Balance%20Sheets) As of June 30, 2025, the company's total assets decreased to $37.3 million from $86.7 million at year-end 2024, primarily driven by a reduction in cash and cash equivalents from $79.4 million to $30.4 million Condensed Balance Sheet Summary (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $30,421 | $79,398 | | Total current assets | $34,511 | $83,646 | | **Total Assets** | **$37,342** | **$86,691** | | **Liabilities & Equity** | | | | Total current liabilities | $17,749 | $27,296 | | Total liabilities | $19,904 | $29,685 | | Total stockholders' equity | $17,438 | $57,006 | | **Total Liabilities & Stockholders' Equity** | **$37,342** | **$86,691** | [Condensed Statements of Operations](index=8&type=section&id=Condensed%20Statements%20of%20Operations) For the three months ended June 30, 2025, the company reported a net loss of $21.3 million, compared to a net income of $2.9 million in the same period of 2024 Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $0 | $144 | $0 | $334 | | Research and Development | $9,923 | $10,004 | $17,760 | $22,221 | | General and Administrative | $13,175 | $10,580 | $30,863 | $19,646 | | Loss from Operations | $(23,098) | $(20,440) | $(48,623) | $(41,533) | | Change in fair value of warrant liabilities | $1,437 | $22,744 | $4,541 | $(40,660) | | **Net Income (Loss)** | **$(21,330)** | **$2,898** | **$(43,155)** | **$(81,040)** | | **Net Income (Loss) per Share - basic** | **$(0.15)** | **$0.02** | **$(0.30)** | **$(0.60)** | [Condensed Statements of Stockholders' Equity/(Deficit)](index=9&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity%2F(Deficit)) Stockholders' equity decreased from $57.0 million at the beginning of 2025 to $17.4 million as of June 30, 2025 - The company's accumulated deficit grew from **$574.2 million** at the start of 2025 to **$617.4 million** by the end of Q2 2025, reflecting the ongoing net losses[27](index=27&type=chunk) [Condensed Statements of Cash Flows](index=11&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the first six months of 2025, the company used $49.0 million in cash for operating activities and had no financing activities, resulting in a cash balance of $30.4 million Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(48,977) | $(41,506) | | Net cash provided by financing activities | $0 | $113,805 | | **Net (Decrease) Increase in Cash** | **$(48,977)** | **$72,299** | | Cash at beginning of period | $79,398 | $49,898 | | **Cash at end of period** | **$30,421** | **$122,197** | [Notes to Condensed Financial Statements (Unaudited)](index=12&type=section&id=Notes%20to%20Condensed%20Financial%20Statements%20(Unaudited)) Notes detail accounting policies, a 'going concern' warning, license agreements, warrant liabilities, litigation, and the AT-001 out-licensing agreement - Management has concluded that substantial doubt exists regarding the company's ability to continue as a going concern within one year, given its net loss of **$43.2 million** for the six months ended June 30, 2025, and cash balance of **$30.4 million**[35](index=35&type=chunk)[36](index=36&type=chunk) - The company is involved in a securities class action lawsuit and a shareholder derivative action. As of June 30, 2025, the probability of loss was deemed reasonably possible, but the company could not estimate a range of loss and has not recorded a liability[123](index=123&type=chunk)[124](index=124&type=chunk)[125](index=125&type=chunk) - On July 31, 2025, the company entered into an out-licensing agreement with Biossil, Inc. for AT-001, receiving a **$1.0 million** upfront payment and eligibility for future royalties and milestones[126](index=126&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=37&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical developments, including FDA setbacks for govorestat, increased G&A expenses, decreased cash, and the 'going concern' warning, emphasizing the need for additional capital [Overview](index=37&type=section&id=Overview) Applied Therapeutics is a clinical-stage biopharmaceutical company developing novel product candidates against validated molecular targets in rare diseases, with a primary focus on aldose reductase (AR) inhibitors - The FDA issued a Complete Response Letter (CRL) for the govorestat NDA for Classic Galactosemia in November 2024, citing deficiencies in the clinical application. The company subsequently withdrew its European Marketing Authorization Application (MAA)[130](index=130&type=chunk) - The company is analyzing data from the Phase 2/3 INSPIRE trial for AT-007 in CMT-SORD and plans to meet with the FDA in Q3 2025 to discuss a potential NDA submission[132](index=132&type=chunk) - On July 31, 2025, the company out-licensed its AT-001 (caficrestat) program for Diabetic Cardiomyopathy to Biossil, Inc., receiving a **$1.0 million** upfront payment[135](index=135&type=chunk) [Results of Operations](index=45&type=section&id=Results%20of%20Operations) For the three and six months ended June 30, 2025, the company reported increased net losses from operations compared to the prior year, primarily driven by a significant rise in general and administrative expenses Comparison of R&D Expenses (in thousands) | Expense Category | Six Months 2025 | Six Months 2024 | Change | | :--- | :--- | :--- | :--- | | Clinical and pre-clinical | $7,328 | $14,621 | $(7,293) | | Drug manufacturing and formulation | $1,658 | $68 | $1,590 | | Personnel expenses | $5,408 | $3,592 | $1,816 | | **Total R&D Expenses** | **$17,760** | **$22,221** | **$(4,461)** | Comparison of G&A Expenses (in thousands) | Expense Category | Six Months 2025 | Six Months 2024 | Change | | :--- | :--- | :--- | :--- | | Legal and professional fees | $20,058 | $5,563 | $14,495 | | Commercial expenses | $1,297 | $5,288 | $(3,991) | | Personnel expenses | $4,937 | $3,339 | $1,598 | | **Total G&A Expenses** | **$30,863** | **$19,646** | **$11,217** | [Liquidity and Capital Resources](index=51&type=section&id=Liquidity%20and%20Capital%20Resources) The company's financial position raises substantial doubt about its ability to continue as a going concern, with cash and cash equivalents of $30.4 million as of June 30, 2025 - The company concluded there is substantial doubt about its ability to continue as a going concern for 12 months beyond the filing date, with cash and cash equivalents of **$30.4 million** as of June 30, 2025[172](index=172&type=chunk) - Net cash used in operating activities was **$49.0 million** for the first six months of 2025, an increase from **$41.5 million** in the prior year period[175](index=175&type=chunk)[176](index=176&type=chunk) - No cash was provided by financing activities in the first six months of 2025, compared to **$113.8 million** in the same period of 2024, which included proceeds from a private placement and ATM agreement sales[179](index=179&type=chunk)[180](index=180&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=59&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks are interest rate sensitivity and foreign currency sensitivity, with $30.4 million in cash and cash equivalents exposed to fluctuations - The company's cash and cash equivalents of **$30.4 million** as of June 30, 2025, are subject to interest rate risk[194](index=194&type=chunk) - The company is subject to foreign exchange risk from service agreements denominated primarily in the Euro, but does not engage in hedging activities[196](index=196&type=chunk) [Controls and Procedures](index=60&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were effective as of June 30, 2025, with a previously identified material weakness fully remediated - A material weakness related to the information and communication component of the COSO framework, reported for the fiscal year ended December 31, 2024, was fully remediated as of June 30, 2025[199](index=199&type=chunk)[201](index=201&type=chunk) - Remediation actions included the appointment of a new executive chairman and interim CEO, instituting a cross-functional quality council, and hiring a chief regulatory officer and a head of quality[200](index=200&type=chunk) PART II. OTHER INFORMATION This section details legal proceedings, comprehensive risk factors, equity sales, and other disclosures pertinent to the company's operations [Legal Proceedings](index=63&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in a consolidated securities class action lawsuit and a shareholder derivative action, both stemming from allegations related to the govorestat NDA - A consolidated securities class action lawsuit (In re Applied Therapeutics Securities Litigation) alleges violations of the Securities Exchange Act related to statements made between January 3, 2024, and December 2, 2024, concerning the govorestat NDA[206](index=206&type=chunk) - A shareholder derivative action (Hassine v. Shendelman, et al.) has been filed against certain current and former officers and directors based on similar facts as the class action. This action was temporarily stayed by the court on March 5, 2025[207](index=207&type=chunk) [Risk Factors](index=63&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including ongoing losses, a 'going concern' warning, regulatory setbacks for govorestat, funding needs, litigation, third-party reliance, IP vulnerabilities, and stock price volatility [Risks Related to Financial Position and Capital Needs](index=68&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Capital%20Needs) The company has a history of significant operating losses, an accumulated deficit of $617.4 million, and a 'going concern' warning, necessitating substantial additional capital - The company has incurred significant operating losses since inception, with a net loss of **$43.2 million** for the six months ended June 30, 2025, and an accumulated deficit of **$617.4 million**[213](index=213&type=chunk) - The independent registered public accounting firm's report includes a 'going concern' paragraph, indicating substantial doubt about the company's ability to continue operations for 12 months beyond the filing date due to its financial condition[220](index=220&type=chunk) - The company requires substantial additional funding to finance operations, and failure to raise capital could force it to delay, reduce, or terminate development programs[233](index=233&type=chunk) [Risks Related to the Development and Commercialization of Our Product Candidates](index=77&type=section&id=Risks%20Related%20to%20the%20Development%20and%20Commercialization%20of%20Our%20Product%20Candidates) The company's success is highly dependent on its product candidates, particularly govorestat (AT-007), which faces significant regulatory hurdles and development risks - In November 2024, the company received a Warning Letter from the FDA related to its AT-007-1002 study, identifying issues with electronic data capture and a dosing error. Failure to resolve these matters could impede future clinical trials and NDA submissions[246](index=246&type=chunk) - The FDA issued a Complete Response Letter (CRL) for the govorestat NDA for Classic Galactosemia, stating the application is not approvable in its current form due to clinical deficiencies and failure to meet primary endpoints[248](index=248&type=chunk) - All current clinical-stage product candidates target the inhibition of aldose reductase, a mechanism of action for which there are no approved drugs in the U.S., posing a fundamental risk to the entire pipeline[280](index=280&type=chunk) [Risks Related to Our Dependence on Third Parties](index=111&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) The company heavily relies on third parties for critical functions like clinical trials and manufacturing, introducing risks of delays, unreliable data, and inability to obtain regulatory approval - A clinical investigator for the AT-007-1002 study received a Warning Letter from the FDA in November 2024 for non-compliance with regulations, including deviations from the investigational plan. This could impact the data's reliability and future regulatory submissions[352](index=352&type=chunk)[353](index=353&type=chunk) - The company is dependent on third-party contract manufacturers for clinical and potential commercial supplies and does not own its own manufacturing facilities. Any failure by these manufacturers to comply with cGMP or meet specifications could halt development and commercialization[354](index=354&type=chunk) - The company relies on CROs to conduct and monitor clinical trials and is responsible for ensuring their compliance with GCP. Failures by CROs could result in unreliable data and require repeating trials, delaying the approval process[360](index=360&type=chunk)[361](index=361&type=chunk) [Risks Related to Our Intellectual Property](index=116&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) The company's business is critically dependent on licensed intellectual property, facing risks of license breaches, uncertain patent protection, and potential infringement claims - The company's core product candidates, including AT-007, AT-001, and AT-003, are dependent on an exclusive license agreement with Columbia University. A breach or termination of this agreement could halt the development of these products[369](index=369&type=chunk)[371](index=371&type=chunk) - The patent landscape for biotechnology is uncertain, and the company's pending applications may not result in issued patents that provide meaningful protection or prevent competitors from developing similar products[373](index=373&type=chunk)[374](index=374&type=chunk) - The company may face legal proceedings from third parties alleging infringement of their intellectual property rights, which could be costly, time-consuming, and could force the company to cease development or obtain expensive licenses[383](index=383&type=chunk)[385](index=385&type=chunk) [Risks Related to Our Business Operations, Employee Matters and Managing Growth](index=128&type=section&id=Risks%20Related%20to%20Our%20Business%20Operations%2C%20Employee%20Matters%20and%20Managing%20Growth) The company is exposed to significant operational risks, including ongoing litigation, recent leadership changes, and vulnerabilities in internal computer systems - The company is defending against a securities class action lawsuit and a shareholder derivative action following the negative FDA updates in November 2024, which could result in substantial costs and divert resources[409](index=409&type=chunk)[412](index=412&type=chunk) - Recent leadership changes, including the departure of the founder, President, and CEO in December 2024, may create uncertainty and disrupt business and investor relationships[414](index=414&type=chunk) - Internal computer systems are vulnerable to cyber-attacks, which could lead to the loss of clinical trial data, trade secrets, or other proprietary information, potentially delaying regulatory approval and harming the business[419](index=419&type=chunk) [Risks Related to Ownership of Our Common Stock](index=134&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) Ownership of the company's common stock involves high risk due to extreme price volatility, potential delisting from Nasdaq, and no anticipated dividends - The market price of the company's common stock is extremely volatile and has declined significantly, particularly following the FDA's Complete Response Letter and Warning Letter in November 2024[425](index=425&type=chunk)[411](index=411&type=chunk) - On February 7, 2025, the company received a deficiency letter from Nasdaq for failing to maintain the minimum **$1.00** bid price, which could lead to the delisting of its common stock if compliance is not regained[431](index=431&type=chunk) - The company has never paid cash dividends and does not intend to in the foreseeable future, meaning capital appreciation is the sole potential source of gain for stockholders[433](index=433&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=143&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period covered by this report - There were no unregistered sales of equity securities during the reporting period[453](index=453&type=chunk) [Defaults Upon Senior Securities](index=143&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Not applicable. The company reports no defaults upon senior securities [Mine Safety Disclosures](index=143&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable. The company has no mine safety disclosures to report [Other Information](index=143&type=section&id=Item%205.%20Other%20Information) The company reports that no officer or director adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the six months ended June 30, 2025 - No officer or director adopted or terminated a Rule 10b5-1 trading plan during the six months ended June 30, 2025[456](index=456&type=chunk) [Exhibits](index=144&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including management contracts and certifications - Exhibits filed include management contracts and certifications required under the Exchange Act and Sarbanes-Oxley Act[458](index=458&type=chunk)

EXHIBIT 99.1 AVINO SILVER & GOLD MINES LTD. Condensed Consolidated Interim Financial Statements For the three and six months ended June 30, 2025 and 2024 (Unaudited) AVINO SILVER & GOLD MINES LTD. Condensed Consolidated Interim Statements of Financial Position (Expressed in Thousands of US Dollars - Unaudited) | | | | June 30, | | December | | --- | --- | --- | --- | --- | --- | | | Note | | 2025 | | 31, 2024 | | ASSETS | | | | | | | Current assets | | | | | | | Cash | | $ | 37,279 | $ | 27,317 | | Amounts ...

Exhibit 99.1 "In the second quarter we saw continued strong momentum in the enrollment of our FULCRUM-VT study, which we believe validates the market need for our purpose-built technology and brings us one step closer to offering our proprietary ULTC solutions to patients in the United States who suffer from ventricular tachycardia," said Todd Usen, Chief Executive Officer of Adagio. "The team also made meaningful progress in advancing our pipeline through the continued development of our next-generation pr ...

united states Securities and Exchange Commission Washington, D. C. 20549 FORM 10-Q (Mark One) ☑ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended June 30, 2025 OR ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from …… to ……. Commission File Number 0-12114 Cadiz Inc. (Exact name of registrant specified in its charter) DELAWARE 77-0313235 (State or other jurisdiction of (I ...

PART I – FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=ITEM%201.%20Financial%20Statements) This section presents Cadiz Inc.'s unaudited condensed consolidated financial statements for Q2 and H1 2025, reporting a net loss of **$7.7 million** for Q2 and **$17.3 million** for H1, with notes on accounting policies and financial matters [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Cadiz Inc. reported **Q2 2025 revenues of $4.1 million** (up from **$0.5 million**) with a net loss of **$7.7 million**, while **H1 2025 revenues grew to $7.1 million** (from **$1.6 million**) with a net loss widening to **$17.3 million** | Metric ($ in thousands) | Q2 2025 | Q2 2024 | YoY Change | | :--- | :--- | :--- | :--- | | **Total revenues** | $4,126 | $513 | +704.3% | | Operating loss | $(5,777) | $(6,949) | +16.9% | | Net loss | $(7,730) | $(8,872) | +12.9% | | Net loss per common share | $(0.11) | $(0.15) | +26.7% | | Metric ($ in thousands) | H1 2025 | H1 2024 | YoY Change | | :--- | :--- | :--- | :--- | | **Total revenues** | $7,080 | $1,634 | +333.3% | | Operating loss | $(13,310) | $(11,857) | -12.3% | | Net loss | $(17,323) | $(15,722) | -10.2% | | Net loss per common share | $(0.25) | $(0.27) | +7.4% | [Condensed Consolidated Balance Sheets](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets increased to **$136.4 million** from **$134.5 million** at year-end 2024, with cash decreasing to **$13.2 million** and stockholders' equity rising to **$35.6 million** due to capital raising | Balance Sheet Item ($ in thousands) | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $13,205 | $17,292 | | Total current assets | $21,039 | $25,786 | | Total assets | $136,379 | $134,494 | | Long-term debt, net | $58,751 | $56,708 | | Total liabilities | $100,813 | $100,533 | | Total stockholders' equity | $35,566 | $33,961 | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Cash%20Flows) Net cash used in operating activities significantly decreased to **$5.0 million** in H1 2025 from **$9.9 million** in H1 2024, while investing activities used **$10.8 million** and financing provided **$14.3 million** from stock issuance | Cash Flow Activity ($ in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,000) | $(9,936) | | Net cash used in investing activities | $(10,800) | $(467) | | Net cash provided by financing activities | $14,338 | $16,003 | | Net (decrease) increase in cash | $(1,462) | $5,600 | [Condensed Consolidated Statement of Stockholders' Equity](index=8&type=section&id=Unaudited%20Condensed%20Consolidated%20Statement%20of%20Stockholders%27%20Equity) Stockholders' equity increased from **$34.0 million** to **$35.6 million** in H1 2025, driven by **$18.3 million** from a direct offering and stock-based compensation, offset by a **$17.3 million** net loss and **$2.6 million** in preferred dividends - In the first half of 2025, the company issued **5,715,000 shares** through a direct offering, resulting in net proceeds of **$18.3 million**[14](index=14&type=chunk) - The accumulated deficit increased from **$(676.1) million** at the end of 2024 to **$(675.4) million** as of June 30, 2025, after accounting for a net loss of **$17.3 million**, preferred dividends, and a reclassification of prior dividends from accumulated deficit to additional paid-in capital[14](index=14&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=10&type=section&id=Unaudited%20Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) The notes detail accounting policies, liquidity, segment performance, debt, and stock compensation, highlighting the company's two segments and recent equity offerings to fund operations and development projects - The company incurred a net loss of **$17.3 million** for the six months ended June 30, 2025, and had working capital of **$9.4 million**; management believes it can continue as a going concern through potential equity placements, asset sales, or cost reductions[20](index=20&type=chunk)[27](index=27&type=chunk)[29](index=29&type=chunk) - In March 2025, the company raised approximately **$18.3 million** in net proceeds from a registered direct offering of **5,715,000 shares** of common stock[26](index=26&type=chunk) - The company operates in two reportable segments: Land and Water Resources, which is in a pre-revenue development phase, and Water Filtration Technology (ATEC), which provides the majority of current revenues[37](index=37&type=chunk) - In March 2024, the company entered into a Third Amended Credit Agreement with Heerema, providing a new **$20 million** senior secured convertible term loan and extending existing debt maturity to June 30, 2027[24](index=24&type=chunk)[48](index=48&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's water solutions business, highlighting significant revenue growth in the ATEC segment, which drove overall revenue increases despite a widening operating loss due to increased development costs and stock-based compensation, with ongoing reliance on debt and equity financing [Business Overview](index=25&type=section&id=Business%20Overview) Cadiz Inc. is a water solutions provider with substantial Southern California assets, focusing on developing its Mojave Groundwater Bank, securing **85%** of Northern Pipeline capacity, and establishing MWI to fund **$800 million** in construction costs with **$425 million** in potential equity - The company's asset portfolio includes **2.5 million acre-feet** of water supply, **1 million acre-feet** of groundwater storage, **220 miles** of existing pipeline, and rights for a new **43-mile** pipeline[100](index=100&type=chunk)[102](index=102&type=chunk)[103](index=103&type=chunk) - In 2024, the company entered into agreements with water providers for the purchase of **21,275 AFY** of annual water supply, representing **85%** of the Northern Pipeline's full capacity[108](index=108&type=chunk) - The company is forming Mojave Water Infrastructure Company, LLC (MWI) to fund the approximately **$800 million** construction cost of the Mojave Groundwater Bank and has non-binding letters of intent for up to **$425 million** in equity capital[112](index=112&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Q2 2025 revenues rose to **$4.1 million** (from **$0.5 million**) with a narrowed operating loss of **$5.8 million**, while H1 2025 revenues grew to **$7.1 million** (from **$1.6 million**), but operating loss increased to **$13.3 million** due to higher development and compensation costs | Segment Performance (in thousands) | Q2 2025 Revenue | Q2 2024 Revenue | Q2 2025 Operating (Loss)/Income | Q2 2024 Operating Loss | | :--- | :--- | :--- | :--- | :--- | | Land and Water Resources | $431 | $350 | $(6,227) | $(6,538) | | Water Filtration Technology | $3,695 | $163 | $450 | $(411) | | Segment Performance (in thousands) | H1 2025 Revenue | H1 2024 Revenue | H1 2025 Operating (Loss)/Income | H1 2024 Operating Loss | | :--- | :--- | :--- | :--- | :--- | | Land and Water Resources | $996 | $986 | $(13,853) | $(11,324) | | Water Filtration Technology | $6,084 | $648 | $543 | $(533) | - The increase in ATEC sales in H1 2025 is attributed to the shipment of **195 filters** compared to **37 filters** in H1 2024[126](index=126&type=chunk) - General and administrative expenses for H1 2025, excluding stock-based compensation, increased to **$11.7 million** from **$8.7 million** in H1 2024, due to higher legal, consulting, and marketing costs[128](index=128&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) The company relies on debt and equity financing, raising **$40.4 million** from two direct offerings for the Mojave Groundwater Bank, with cash used in operations decreasing to **$5.0 million** in H1 2025, while investing activities increased to **$10.8 million** - Completed a registered direct offering in November 2024 for net proceeds of approximately **$22.1 million**[132](index=132&type=chunk) - Completed a registered direct offering in March 2025 for net proceeds of approximately **$18.3 million**[133](index=133&type=chunk) - In March 2024, the company amended its credit agreement, securing a new **$20 million** convertible term loan and extending the maturity of existing debt to June 30, 2027[139](index=139&type=chunk) - Cash used in operating activities decreased to **$5.0 million** in H1 2025 from **$9.9 million** in H1 2024, driven by lower working capital needs at ATEC[144](index=144&type=chunk) [Outlook](index=34&type=section&id=Outlook) The company has sufficient short-term working capital from recent equity offerings and cash on hand, but requires additional long-term capital for the Mojave Groundwater Bank and other projects, potentially through equity, debt, or asset dispositions - The company has sufficient funds for short-term working capital needs following the March 2025 Direct Offering[147](index=147&type=chunk) - Long-term capital will be needed to finance the Mojave Groundwater Bank, with the timing dependent on MWI funding and reimbursement of development costs[148](index=148&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=35&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Cadiz Inc. is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, the registrant is not required to provide quantitative and qualitative disclosures about market risk[152](index=152&type=chunk) [Controls and Procedures](index=35&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, 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 last fiscal quarter - The Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[153](index=153&type=chunk) - No material changes to the company's internal control over financial reporting were identified during the last fiscal quarter[154](index=154&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=37&type=section&id=ITEM%201.%20Legal%20Proceedings) No material changes to legal proceedings have occurred since the Annual Report on Form 10-K for the year ended December 31, 2024 - No material changes to legal proceedings have occurred since the last annual report[157](index=157&type=chunk) [Risk Factors](index=37&type=section&id=ITEM%201A.%20Risk%20Factors) No material changes to risk factors have occurred since the Annual Report on Form 10-K for the year ended December 31, 2024 - No material changes to risk factors have occurred since the last annual report[158](index=158&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable for the current reporting period - Not applicable[159](index=159&type=chunk) [Other Information](index=37&type=section&id=ITEM%205.%20Other%20Information) The company reported no Form 8-K information or nomination process modifications, and no director or officer adopted or terminated a Rule 10b5-1 trading arrangement during H1 2025 - During the six months ended June 30, 2025, no director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement[162](index=162&type=chunk) [Exhibits](index=38&type=section&id=ITEM%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including CEO and CFO certifications under Sarbanes-Oxley and Inline XBRL financial data files - The report includes certifications from the CEO and CFO as required by Sections 302 and 906 of the Sarbanes-Oxley Act[166](index=166&type=chunk) - Inline XBRL documents are filed concurrently with the report[164](index=164&type=chunk)

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 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 001-41355 Sharps Technology, Inc. (Exact name of registrant as specified in its charter) State or other jurisdiction of incorporation or organization (I.R.S. Employer Identification No.) ...

[Business and Operational Highlights](index=1&type=section&id=Business%20and%20Operational%20Highlights) Biofrontera Inc. achieved double-digit revenue growth in H1 2025, driven by strategic restructuring, IP acquisition, and clinical trial advancements Revenue Performance | Period | Revenue | YoY Growth | | :--- | :--- | :--- | | Q2 2025 | $9.0 million | 15% | | H1 2025 | $17.7 million | 12% | - Cash and cash equivalents increased to **$7.2 million** as of June 30, 2025, from **$5.9 million** at the end of 2024[3](index=3&type=chunk) - A major restructuring with Biofrontera AG was agreed upon, including the acquisition of U.S. IP and NDAs, supported by an additional **$11 million** in funding[3](index=3&type=chunk) - A new U.S. patent was granted for a revised Ameluz® formulation, extending patent protection through **December 2043**[3](index=3&type=chunk) - Significant progress was made in clinical trials, including completing patient follow-up in a Phase 3 sBCC study and completing enrollment in Phase 3 and Phase 2b studies for AK and acne, respectively[3](index=3&type=chunk) [Strategic Restructuring with Biofrontera AG](index=2&type=section&id=Strategic%20Restructuring%20with%20Biofrontera%20AG) Biofrontera Inc. acquired all U.S. rights for Ameluz® and RhodoLED® from Biofrontera AG, shifting to a royalty model to enhance profitability - The company is acquiring all U.S. rights, approvals, patents, IP, NDA, and manufacturing capabilities for Ameluz® and RhodoLED® lamps from Biofrontera AG[4](index=4&type=chunk) Agreement Payment Structure Comparison | Agreement Term | Old Model (Transfer Pricing) | New Model (Royalty) | | :--- | :--- | :--- | | **Payment Structure** | 25% to 35% of net sales price per tube | 12% of revenue (if <$65M/yr) or 15% of revenue (if >$65M/yr) | - The restructuring and operational improvements are supported by a secured **$11 million** investment, positioning the company for future growth[4](index=4&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) Revenue increased in Q2 and H1 2025 due to Ameluz® sales, but rising legal costs impacted net loss and Adjusted EBITDA [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Q2 2025 revenues grew 15% to $9.0 million, but increased legal costs and warrant fair value changes led to a widened net loss of $5.3 million Q2 2025 Revenue Performance | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | **Total Revenues** | $9.0 million | $7.8 million | +15% | | **Ameluz® Sales Volume** | - | - | +9.5% | Q2 2025 Operating Expenses | Expense Category | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | **Total Operating Expenses** | $14.1 million | $12.9 million | +9.3% | | **Cost of Revenues** | $2.6 million | $4.3 million | -41.8% | | **SG&A Expenses** | $10.5 million | $7.9 million | +32.9% | Q2 2025 Net Loss and Adjusted EBITDA | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | **Net Loss** | $5.3 million | $0.3 million | | **Adjusted EBITDA** | ($5.1 million) | ($4.7 million) | [Six-Month 2025 Financial Results](index=3&type=section&id=Six-Month%202025%20Financial%20Results) H1 2025 revenues rose 12% to $17.6 million, with legal expense increases largely offset by reduced cost of revenues, resulting in flat Adjusted EBITDA H1 2025 Revenue Performance | Metric | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | | **Total Revenues** | $17.6 million | $15.8 million | +12% | H1 2025 Operating Expenses | Expense Category | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | | **Total Operating Expenses** | $27.2 million | $26.3 million | +3.4% | | **Cost of Revenues** | $5.5 million | $8.0 million | -31.3% | | **SG&A Expenses** | $19.2 million | $17.2 million | +11.6% | H1 2025 Adjusted EBITDA | Metric | H1 2025 | H1 2024 | | :--- | :--- | :--- | | **Adjusted EBITDA** | ($9.5 million) | ($9.3 million) | [Financial Statements](index=5&type=section&id=Financial%20Statements) Consolidated financial statements detail the company's financial position and performance, highlighting changes in cash, liabilities, and stockholders' deficit [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, cash increased to $7.2 million, total assets decreased, and total liabilities rose to $24.8 million, leading to a $4.7 million stockholders' deficit Condensed Consolidated Balance Sheets | Balance Sheet Item | June 30, 2025 (in thousands) | Dec 31, 2024 (in thousands) | | :--- | :--- | :--- | | **Cash and cash equivalents** | $7,239 | $5,905 | | **Total current assets** | $18,815 | $20,700 | | **Total assets** | $20,142 | $22,101 | | **Total current liabilities** | $19,687 | $12,021 | | **Total liabilities** | $24,810 | $17,668 | | **Total stockholders' (deficit) equity** | $(4,668) | $4,433 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For H1 2025, the company reported $17.6 million in revenue and a net loss of $9.5 million, or ($1.05) per share Condensed Consolidated Statements of Operations (Six Months Ended June 30) | Statement of Operations (Six Months Ended June 30) | 2025 (in thousands) | 2024 (in thousands) | | :--- | :--- | :--- | | **Total revenues, net** | $17,617 | $15,750 | | **Total operating expenses** | $27,246 | $26,288 | | **Loss from operations** | $(9,629) | $(10,538) | | **Net loss** | $(9,527) | $(10,694) | | **Loss per common share (Basic and diluted)** | $(1.05) | $(2.45) | [GAAP to Non-GAAP Reconciliation](index=7&type=section&id=GAAP%20to%20Non-GAAP%20Reconciliation) This section reconciles GAAP net loss to Adjusted EBITDA, showing a $(9,527) thousand net loss adjusted to $(9,520) thousand Adjusted EBITDA for H1 2025 GAAP to Non-GAAP Reconciliation (Six Months Ended June 30) | Reconciliation (Six Months Ended June 30) | 2025 (in thousands) | 2024 (in thousands) | | :--- | :--- | :--- | | **Net loss** | $(9,527) | $(10,694) | | **Adjustments (Interest, Tax, D&A, etc.)** | $2 | $1,386 | | **Adjusted EBITDA** | $(9,520) | $(9,308) | [Company Information and Forward-Looking Statements](index=4&type=section&id=Company%20Information%20and%20Forward-Looking%20Statements) Biofrontera Inc. is a U.S. biopharmaceutical company focused on dermatological PDT, with forward-looking statements subject to inherent risks and uncertainties - The company commercializes pharmaceutical products for dermatological conditions, with a focus on photodynamic therapy (PDT) and topical antibiotics for treating actinic keratoses[16](index=16&type=chunk) - The press release includes forward-looking statements concerning revenue guidance, business strategy, clinical trials, and market opportunities, which are subject to significant risks and uncertainties[17](index=17&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 ☐ 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 001-40677 PLUM ACQUISITION CORP. III (Exact name of registrant as specified in its charter) Cayman Islands 98-1581691 (State or other ju ...