[Executive Summary & Business Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Highlights) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) CEO Jack Ross celebrated Synergy CHC Corp.'s tenth profitable quarter, highlighting year-over-year growth, global brand expansion, beverage business growth, and successful debt refinancing - Reported tenth consecutive quarter of profitability[4](index=4&type=chunk) - Revenue, gross profit, net income, and earnings per share all grew year-over-year[4](index=4&type=chunk) - Expanded the global footprint of the FOCUSfactor brand through a licensing agreement in Turkey[4](index=4&type=chunk) - Secured distribution partners across North America for the RTD beverage business[4](index=4&type=chunk) - Successfully completed a **$20 million** debt refinancing, extending maturity profile and enhancing financial flexibility[4](index=4&type=chunk) [Second Quarter 2025 Financial Summary](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Summary) Synergy CHC Corp. reported strong Q2 2025 results: revenue up 1% to $8.1 million, gross margin at 76.7%, net income up 125% to $1.5 million, and EBITDA surging 136% to $3.80 million Q2 2025 Financial Performance vs. Q2 2024 | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--------------------- | :---------- | :---------- | :----------- | | Revenue | $8.1 million | $8.0 million | +1% | | Gross Margin | 76.7% | 69.5% | +7.2 ppts | | Income from Operations | $1.62 million | $1.58 million | +2.5% | | Net Income | $1.5 million | $655.2 thousand | +125% | | Earnings Per Share | $0.17 | $0.09 | +86% | | EBITDA (non-GAAP) | $3.80 million | $1.61 million | +136% | [Recent Business Highlights](index=1&type=section&id=Recent%20Business%20Highlights) Recent highlights include major North American retail and distribution wins for FOCUSfactor and beverages, international expansion to Turkey, a $20 million term loan, key beverage hires, and significant liability reductions - Announced major North American retail and distribution wins across FOCUSfactor supplement and beverage lines, expected to yield significant results in the fourth quarter of 2025[7](index=7&type=chunk) - Expanded international licensing deal with Gravity Pharma, adding Turkey alongside the UAE for exclusive distribution of FOCUSfactor[7](index=7&type=chunk) - Entered into a **$20 million** term loan credit agreement, due May 2029, with **$17.5 million** drawn[7](index=7&type=chunk) - Added key individuals to drive the Company's beverage growth during the second quarter[7](index=7&type=chunk) - Reduced outstanding liabilities by **$869 thousand** during the second quarter and by an additional **$1.8 million** subsequent to quarter end[7](index=7&type=chunk) [Detailed Financial Performance](index=2&type=section&id=Detailed%20Financial%20Performance) [Second Quarter 2025 Income Statement Analysis](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Q2 2025 total revenue rose 1% to $8.1 million, driven by $1.4 million license revenue. Gross margin improved to 76.7%, net income surged 125% to $1.5 million, and diluted EPS grew 86% to $0.17 Q2 2025 Income Statement Highlights (YoY Comparison) | Metric | Q2 2025 ($) | Q2 2024 ($) | Change (YoY) | | :--------------------- | :---------- | :---------- | :----------- | | Total Revenue | $8.1 million | $8.0 million | +1% | | Product Sales | $6.73 million | $8.02 million | -16.1% | | License Revenue | $1.40 million | $0 | N/A | | Gross Margin | 76.7% | 69.5% | +7.2 ppts | | Operating Expenses | $4.6 million | $4.0 million | +16% | | Income from Operations | $1.62 million | $1.58 million | +2.5% | | Net Income | $1.5 million | $655.2 thousand | +125% | | Diluted EPS | $0.17 | $0.09 | +86% | - The increase in gross margin was largely driven by license revenue[8](index=8&type=chunk) - The increase in operating expenses was driven by incremental costs associated with being a public company[9](index=9&type=chunk) [Balance Sheet and Cash Flow Overview](index=2&type=section&id=Balance%20Sheet%20and%20Cash%20Flow%20Overview) As of June 30, 2025, cash increased to $1.5 million, working capital shifted to a $12.4 million surplus, and inventory rose to $2.4 million. Operating cash outflow decreased, with financing activities providing $1.63 million Balance Sheet Highlights (Period-end Comparison) | Metric | June 30, 2025 ($) | December 31, 2024 ($) | Change ($) | | :-------------------------- | :-------------- | :---------------- | :------- | | Cash and Cash Equivalents | $1.5 million | $687.9 thousand | +$770.6K | | Working Capital | $12.4 million surplus | $1.12 million deficit | Significant improvement | | Inventory | $2.4 million | $1.7 million | +$0.7M | Cash Flow from Operating Activities (Six Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change ($) | | :-------------------------------- | :----------- | :----------- | :------- | | Net cash used in operating activities | $(899.7) thousand | $(1.1) million | -$240.3K | - Net cash provided by financing activities for the six months ended June 30, 2025, was **$1.63 million**, primarily driven by proceeds from notes payable (**$18.99 million**) partially offset by repayments of notes payable (**$15.38 million**)[26](index=26&type=chunk) [Non-GAAP Financial Measure Reconciliation: EBITDA](index=2&type=section&id=Non-GAAP%20Financial%20Measure%20Reconciliation%3A%20EBITDA) Synergy CHC Corp. presents EBITDA as a non-GAAP measure to clarify core operating results, with Q2 2025 EBITDA significantly increasing to $3.80 million from $1.61 million in Q2 2024 - EBITDA is disclosed as a non-GAAP financial measure to enhance investors' overall understanding of financial performance by excluding certain items that may not be indicative of core operating results[14](index=14&type=chunk)[15](index=15&type=chunk) EBITDA Reconciliation (Three Months Ended June 30) | Metric | Q2 2025 ($) | Q2 2024 ($) | | :-------------------------- | :---------- | :---------- | | Net income for the period | $1.47 million | $0.66 million | | Adjusted for: | | | | Interest expense, net | $2.11 million | $0.74 million | | Amortization of intangible assets | $0.03 million | $0.03 million | | Tax expense | $0.19 million | $0.18 million | | **EBITDA** | **$3.80 million** | **$1.61 million** | [Company Information](index=3&type=section&id=Company%20Information) [About Synergy CHC Corp.](index=3&type=section&id=About%20Synergy%20CHC%20Corp.) Synergy CHC Corp. is a consumer health and wellness company, offering FOCUSfactor brain supplements and Flat Tummy women's wellness and weight management products - Synergy CHC Corp. is a provider of consumer health and wellness products[18](index=18&type=chunk) - Its brand portfolio includes FOCUSfactor (brain health supplement) and Flat Tummy (women's wellness and weight management)[18](index=18&type=chunk) [Forward Looking Statements](index=3&type=section&id=Forward%20Looking%20Statements) This report contains forward-looking statements on future events, subject to risks and uncertainties outlined in SEC filings, and the company does not commit to updates unless legally required - Statements regarding expansion and growth initiatives, refinancing of indebtedness, and free cash flow constitute "forward-looking statements"[19](index=19&type=chunk) - These forward-looking statements are subject to risks, uncertainties, and other factors that could cause actual results to differ materially from the results discussed[19](index=19&type=chunk)[20](index=20&type=chunk) - Synergy does not undertake any obligation to update or revise any forward-looking statement, except as required by law[20](index=20&type=chunk) [Investor Relations](index=3&type=section&id=Investor%20Relations) Investor relations inquiries for Synergy CHC Corp. can be directed to Gateway Group, with contacts Cody Slach and Greg Robles, via phone or email - Investor Relations contact information is provided for Gateway Group (Cody Slach, Greg Robles) via phone and email[21](index=21&type=chunk) [Condensed Consolidated Financial Statements](index=4&type=section&id=Condensed%20Consolidated%20Financial%20Statements) [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets increased to $19.7 million, total liabilities decreased to $32.1 million, and the stockholders' deficit improved to $(12.4) million Condensed Consolidated Balance Sheets (Selected Items) | Item | June 30, 2025 ($) | December 31, 2024 ($) | | :------------------------------------------ | :-------------- | :---------------- | | **Assets** | | | | Cash and cash equivalents | $1,458,561 | $687,920 | | Accounts receivable, net | $7,069,889 | $5,321,037 | | Inventory, net | $2,364,158 | $1,716,552 | | Total Current Assets | $19,509,679 | $16,059,768 | | Total Assets | $19,726,346 | $16,343,101 | | **Liabilities** | | | | Total Current Liabilities | $7,126,547 | $17,184,369 | | Notes payable, net of debt discount (long-term) | $24,978,999 | $7,457,022 | | Total Liabilities | $32,105,546 | $32,974,444 | | **Stockholders' Deficit** | | | | Total stockholders' deficit | $(12,379,200) | $(16,631,343) | [Unaudited Condensed Consolidated Statements of Income and Comprehensive Income](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Income%20and%20Comprehensive%20Income) The income statement shows Q2 2025 total revenue at $8.1 million with $1.5 million net income. For H1 2025, total revenue was $16.3 million, and net income reached $2.3 million, indicating improved profitability Condensed Consolidated Statements of Income (Three Months Ended June 30) | Metric | Q2 2025 ($) | Q2 2024 ($) | | :-------------------------------- | :---------- | :---------- | | Product Sales | $6,734,996 | $8,024,840 | | License Revenue | $1,400,000 | - | | Total Revenue | $8,134,996 | $8,024,840 | | Cost of sales | $1,896,391 | $2,448,890 | | Gross profit | $6,238,605 | $5,575,950 | | Operating expenses | $4,614,870 | $3,992,358 | | Income from operations | $1,623,735 | $1,583,592 | | Net income after tax | $1,473,237 | $655,186 | | Net income per share – basic | $0.17 | $0.09 | Condensed Consolidated Statements of Income (Six Months Ended June 30) | Metric | H1 2025 ($) | H1 2024 ($) | | :-------------------------------- | :---------- | :---------- | | Product Sales | $13,405,530 | $17,436,703 | | License Revenue | $2,900,000 | - | | Total Revenue | $16,305,530 | $17,436,703 | | Cost of sales | $3,902,904 | $5,086,029 | | Gross profit | $12,402,626 | $12,350,674 | | Operating expenses | $8,831,188 | $8,958,753 | | Income from operations | $3,571,438 | $3,391,921 | | Net income after tax | $2,349,501 | $1,235,716 | | Net income per share – basic | $0.27 | $0.17 | [Unaudited Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For H1 2025, operating cash outflow improved to $899.7 thousand, while financing activities provided $1.63 million, resulting in a net cash increase of $770.6 thousand Condensed Consolidated Statements of Cash Flows (Six Months Ended June 30) | Metric | H1 2025 ($) | H1 2024 ($) | | :------------------------------------------ | :-------------- | :-------------- | | Net income | $2,349,501 | $1,235,716 | | Amortization of debt discount and debt issuance cost | $892,435 | - | | Gain on settlement of debt | $(2,154,522) | - | | Net cash used in operating activities | $(899,731) | $(1,140,005) | | Net cash provided by financing activities | $1,632,433 | $407,391 | | Net increase (decrease) in cash, cash equivalents and restricted cash | $770,641 | $(545,241) | | Cash and restricted cash, end of period | $1,558,561 | $187,293 | - Significant financing activities included proceeds from notes payable of **$18,996,250** and repayment of notes payable of **$15,382,903** for the six months ended June 30, 2025[26](index=26&type=chunk)

PART I – FINANCIAL INFORMATION [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The company's unaudited interim financial statements show a net loss of $5.8 million and substantial doubt about its ability to continue as a going concern [Interim Condensed Consolidated Balance Sheets](index=7&type=section&id=Interim%20Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2025, shows total assets of $2.6 million and a total stockholders' deficit of $6.1 million Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $824 | $187 | | Total current assets | $1,515 | $385 | | Total assets | $2,566 | $1,832 | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $8,528 | $8,978 | | Total liabilities | $8,623 | $9,596 | | Accumulated deficit | $(232,403) | $(226,636) | | Total stockholders' deficit | $(6,057) | $(7,764) | [Interim Condensed Consolidated Statements of Comprehensive Loss](index=9&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) The company recorded a net loss of $5.77 million for the six months ended June 30, 2025, a slight decrease from the prior year Statement of Comprehensive Loss (in thousands, except per share data) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development, net | $2,424 | $1,883 | $1,120 | $922 | | General and administrative | $3,238 | $3,573 | $1,453 | $2,060 | | **Operating loss** | **$(5,662)** | **$(5,456)** | **$(2,573)** | **$(2,982)** | | **Net loss** | **$(5,767)** | **$(5,942)** | **$(2,903)** | **$(2,541)** | | Basic and diluted net loss per share | $(0.77) | $(1.35) | $(0.34) | $(0.60) | [Interim Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $5.1 million, offset by $5.8 million raised from financing activities during the first half of 2025 Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,133) | $(4,746) | | Net cash provided by financing activities | $5,787 | $6,909 | | Increase (decrease) in cash, cash equivalents and restricted cash | $654 | $2,163 | | Cash, cash equivalents and restricted cash at end of the period | $1,025 | $3,648 | [Notes to Interim Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Interim%20Condensed%20Consolidated%20Financial%20Statements) Key notes highlight the company's delisting to the OTCQB market, substantial doubt about its going concern status, and recent capital-raising activities - The company's common stock was **delisted from The Nasdaq Capital Market** and began trading on the OTCQB Venture Market on July 18, 2025, due to failure to meet the minimum shareholder equity requirement[38](index=38&type=chunk)[39](index=39&type=chunk)[82](index=82&type=chunk) - The company has incurred operating losses since inception, with an **accumulated deficit of approximately $232 million** as of June 30, 2025, raising **substantial doubts about its ability to continue as a going concern**[40](index=40&type=chunk)[41](index=41&type=chunk) - During the six months ended June 30, 2025, the company sold **2,311,940 shares for gross proceeds of approximately $4.15 million** under its At-the-Market (ATM) offering[54](index=54&type=chunk) - In March 2025, the company entered into a warrant inducement agreement, **raising approximately $1.64 million** and issuing new warrants to purchase additional shares[57](index=57&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the regulatory pathway for its NurOwn® cell therapy, its precarious financial condition, and reliance on equity financing [Company Overview and Recent Highlights](index=26&type=section&id=Company%20Overview%20and%20Recent%20Highlights) Recent highlights include the delisting from Nasdaq, FDA clearance for a Phase 3b trial for NurOwn® in ALS, and a new manufacturing agreement - The company's common stock was **delisted from Nasdaq** and began trading on the OTCQB market on July 18, 2025, due to non-compliance with the minimum shareholder equity requirement[90](index=90&type=chunk) - On May 19, 2025, the company announced that the **FDA cleared the initiation of its Phase 3b clinical trial** of NurOwn® for the treatment of ALS[90](index=90&type=chunk) - The company signed a Letter of Intent with Minaris Advanced Therapies on May 27, 2025, to **manufacture NurOwn® for its upcoming clinical trial**[97](index=97&type=chunk) [NurOwn® Clinical Program](index=32&type=section&id=NurOwn%C2%AE%20Clinical%20Program) The company withdrew its BLA for NurOwn® in ALS but subsequently secured an FDA Special Protocol Assessment for a new Phase 3b trial - The company **withdrew its Biologics License Application (BLA) for NurOwn® in ALS** on November 3, 2023, after an Advisory Committee voted against its effectiveness[100](index=100&type=chunk)[123](index=123&type=chunk) - In April 2024, the company received **written agreement from the FDA under a Special Protocol Assessment (SPA)** for the design of a new Phase 3b trial of NurOwn® in ALS[86](index=86&type=chunk)[100](index=100&type=chunk)[123](index=123&type=chunk) - The Phase 2 trial for NurOwn® in Progressive Multiple Sclerosis (PMS) showed positive top-line data, with **38% of patients showing improvement in walking function**[146](index=146&type=chunk) [Research and Development](index=49&type=section&id=Research%20and%20Development) R&D efforts are focused on NurOwn® and its derivative, MSC-NTF derived Exosomes, for various neurodegenerative disorders - R&D efforts are focused on **MSC-NTF derived Exosomes**, which are nano-vesicles that can cross the blood-brain barrier and may treat multiple neurodegenerative diseases[161](index=161&type=chunk) - A preclinical study showed that intratracheal administration of NurOwn® derived exosomes resulted in a **statistically significant improvement in multiple lung parameters** in a mouse model of ARDS[166](index=166&type=chunk) [Results of Operations](index=53&type=section&id=Results%20of%20Operations) The company generated no revenue and incurred a net loss of $5.8 million for the first six months of 2025, with R&D expenses increasing by 28.7% Comparison of Operating Results (in thousands) | Expense Category | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and Development, net | $2,424 | $1,883 | $541 | +28.7% | | General and Administrative | $3,238 | $3,573 | $(335) | -9.4% | | **Operating Loss** | **$5,662** | **$5,456** | **$206** | **+3.8%** | | **Net Loss** | **$5,767** | **$5,942** | **$(175)** | **-2.9%** | - The increase in R&D expenses for the first six months of 2025 was primarily due to a **$387,000 increase in payroll** and a **$294,000 increase in clinical activities**[180](index=180&type=chunk) - The decrease in G&A expenses for the first six months of 2025 was mainly due to **lower costs for payroll, PR activities, rent, and consultants**[182](index=182&type=chunk) [Liquidity and Capital Resources](index=55&type=section&id=Liquidity%20and%20Capital%20Resources) The company's ability to continue as a going concern is in doubt, as it requires substantial additional funding which may be hampered by its delisting - As of June 30, 2025, the company had **cash, cash equivalents, and restricted cash of $1,025,000**[190](index=190&type=chunk) - For the six months ended June 30, 2025, the company **raised $5.8 million from financing activities**, including approximately $4.1 million from its ATM stock offering[192](index=192&type=chunk)[193](index=193&type=chunk) - The company anticipates needing to **raise substantial additional financing** to fund operations and the planned Phase 3b trial, but its ability to do so is uncertain[187](index=187&type=chunk)[189](index=189&type=chunk)[205](index=205&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=61&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is omitted as the company qualifies as a smaller reporting company - The company is a **smaller reporting company** and is not required to provide the information under this item[211](index=211&type=chunk) [Item 4. Controls and Procedures](index=63&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were not effective due to a material weakness in internal controls over short-term loans - Management concluded that **disclosure controls and procedures were not effective** as of June 30, 2025, due to a material weakness in internal control over financial reporting[213](index=213&type=chunk) - The material weakness was related to controls over the **initiation, review, authorization, and execution of short-term loans** but did not result in a misstatement[216](index=216&type=chunk) - A **remediation plan has been adopted** to address the material weakness, though the weakness is not yet considered fully remediated[217](index=217&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=63&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in several lawsuits, including a securities class action and shareholder derivative actions related to FDA communications - A **putative securities class action** was filed against the company, alleging violations related to communications with the FDA about NurOwn® for ALS[220](index=220&type=chunk)[221](index=221&type=chunk) - **Four shareholder derivative actions** have been filed, asserting claims for breach of fiduciary duty and unjust enrichment against officers and directors[222](index=222&type=chunk) - 3D Communications, LLC filed a **breach of contract lawsuit** against the company in November 2024, alleging non-payment for consulting services[223](index=223&type=chunk) [Item 1A. Risk Factors](index=65&type=section&id=Item%201A.%20Risk%20Factors) Key risks include the consequences of delisting from Nasdaq, adverse macroeconomic conditions, and a material weakness in internal controls - The **delisting from Nasdaq** could lead to limited liquidity, reduced trading activity, less analyst coverage, and a decreased ability to raise future financing[228](index=228&type=chunk)[229](index=229&type=chunk) - The company faces risks from **adverse macroeconomic conditions**, including inflation and rising interest rates, which could impair its ability to raise additional funding[232](index=232&type=chunk) - The company has incurred **unsecured short-term debt**, which increases financial obligations and could adversely affect its financial condition[234](index=234&type=chunk) - The identified **material weakness in internal controls**, if not remediated, could result in material misstatements in future financial statements[235](index=235&type=chunk)[236](index=236&type=chunk) [Item 5. Other Information](index=69&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, terminated, or modified a Rule 10b5-1 trading arrangement during the quarter - No directors or officers adopted, terminated, or modified a **Rule 10b5-1 trading plan** during the second quarter of 2025[240](index=240&type=chunk) [Item 6. Exhibits](index=71&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications and XBRL data files

Exhibit 99.1 PAVmed Provides Business Update and Reports Second Quarter 2025 Financial Results Lucid processed 2,756 EsoGuard 2Q25 tests, recognized revenue of $1.2 million, and secured CAC meeting on Medicare LCD for EsoGuard to be held on September 4 Veris Health completed 2Q25 financing, relaunched development of implantable physiological monitor, and initiated integration steps to launch commercial phase with OSU-The James Conference call and webcast to be held today, August 14, at 8:30 AM EDT Business ...

Exhibit 99.1 Cocrystal Pharma Reports Second Quarter 2025 Financial Results and Provides Updates on its Antiviral Drug-Development Programs BOTHELL, Wash. (August 14, 2025) – Cocrystal Pharma, Inc. (Nasdaq: COCP) ("Cocrystal" or the "Company") reports financial results for the three and six months ended June 30, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and business activities. "Preparations are underway for a Phase 1b norovirus challenge study to evaluate our potent, ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Commission File Number) (I.R.S. Employer Identification No.) FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 August 14, 2025 Date of Report (Date of earliest event reported) Enveric Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 001-38286 95-4484725 (State or other jurisdiction of incorporation) Enveric Biosciences, Inc. 4851 Tamiami Trail N, Suite 200 Na ...

Exhibit 99.1 Falcon's Beyond Reports Second Quarter 2025 Financial Results Company Reports Consolidated Revenue of $2.5 Million Company's Unconsolidated Subsidiary, Falcon's Creative Group generated Q2 Revenue of $12.3 Million Company's Unconsolidated Joint Venture, Producciones de Parques, recognized a $59.6 Million gain on sale of the Sol Tenerife hotel and generated Q2 revenue of $6.5 Million from continuing operations EBITDA: • Falcon's Beyond's adjusted EBITDA (1) loss decreased $0.2 million to $(1.7) ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number 001-37471 Palvella Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Nevada 30-0784 ...

Exhibit 99.1 Khurram Jamil, M.D., Chief Medical Officer, added, "The 18-month analysis showed a lower incidence of both liver stiffness progression and varices in the 2 mg belapectin arm compared to placebo — an encouraging signal, given that increasing liver stiffness is a well-established predictor of liver-related complications. We are pleased that these effects were maintained in patients who continued into the second 18-month treatment period. Using all available data and LOCF (Last Observation Carried ...

[PART I — FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) [ITEM 1. Unaudited Condensed Consolidated Financial Statements](index=3&type=section&id=ITEM%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section presents Galectin Therapeutics Inc.'s unaudited condensed consolidated financial statements for Q2 2025, detailing balance sheets, operations, cash flows, and stockholders' deficit, with notes on accounting policies and financial instruments [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a decrease in total assets and an increase in total liabilities from December 31, 2024, to June 30, 2025, primarily driven by changes in convertible notes payable and derivative liabilities, leading to an increased stockholders' deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | % Change | | :------------------------------------- | :------------ | :---------------- | :----- | :------- | | Cash and cash equivalents | $13,771 | $15,120 | $(1,349) | -8.92% | | Total current assets | $15,427 | $17,252 | $(1,825) | -10.58% | | Total assets | $15,602 | $17,495 | $(1,893) | -10.82% | | Total current liabilities | $10,774 | $35,409 | $(24,635)| -69.57% | | Total liabilities | $132,769 | $120,565 | $12,204 | 10.12% | | Total stockholders' deficit | $(118,890) | $(104,793) | $(14,097)| 13.45% | - Convertible notes payable and accrued interest (non-current) increased significantly from **$10,733,000** at December 31, 2024, to **$32,308,000** at June 30, 2025[7](index=7&type=chunk) - Borrowing and accrued interest under convertible lines of credit (related party) increased from **$74,376,000** to **$88,150,000**[7](index=7&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a reduced net loss for both the three and six months ended June 30, 2025, compared to the same periods in 2024, primarily due to a significant decrease in research and development expenses, despite an increase in interest expense and change in fair value of derivative liabilities Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $3,261 | $9,813 | $9,746 | $17,867 | | General and administrative | $1,364 | $1,478 | $2,776 | $3,072 | | Total operating expenses | $4,625 | $11,291 | $12,522 | $20,939 | | Total operating loss | $(4,625) | $(11,291) | $(12,522) | $(20,939) | | Interest expense | $(1,826) | $(1,269) | $(3,570) | $(2,321) | | Change in fair value of derivative | $(1,096) | $109 | $(1,121) | $(760) | | Net loss | $(7,521) | $(12,371) | $(17,152) | $(23,860) | | Net loss per common share | $(0.12) | $(0.20) | $(0.27) | $(0.39) | - Research and development expenses decreased by **67%** for the three months ended June 30, 2025, and by **45%** for the six months ended June 30, 2025, compared to the prior year periods[9](index=9&type=chunk) - Net loss applicable to common stockholders decreased from **$(12,435,000)** to **$(7,584,000)** for the three months ended June 30, 2025, and from **$(23,932,000)** to **$(17,189,000)** for the six months ended June 30, 2025[9](index=9&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly decreased for the six months ended June 30, 2025, compared to the same period in 2024, primarily due to lower net loss and adjustments for non-cash items. However, net cash flows from financing activities also decreased, leading to a larger net decrease in cash and cash equivalents Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | | Net loss | $(17,152) | $(23,860) | | Net cash from operating activities | $(14,291) | $(20,438) | | Net cash flows from financing activities | $12,942 | $20,376 | | NET DECREASE IN CASH AND CASH EQUIVALENTS | $(1,349) | $(62) | | CASH AND CASH EQUIVALENTS, END OF PERIOD | $13,771 | $25,598 | - Net cash used in operating activities decreased by **$6,147,000**, from **$(20,438,000)** in 2024 to **$(14,291,000)** in 2025[11](index=11&type=chunk) - Net cash flows from financing activities decreased by **$7,434,000**, from **$20,376,000** in 2024 to **$12,942,000** in 2025, primarily due to decreased borrowings under related party lines of credit[11](index=11&type=chunk)[160](index=160&type=chunk) [Condensed Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders' Deficit](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Redeemable%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Deficit) The statements detail changes in preferred stock and stockholders' deficit, reflecting net losses, preferred stock dividends, common stock issuances from option/warrant exercises, and conversions, leading to an increased accumulated deficit - Total stockholders' deficit increased from **$(104,793,000)** at December 31, 2024, to **$(118,890,000)** at June 30, 2025[7](index=7&type=chunk)[16](index=16&type=chunk) - Common stock outstanding increased from **63,157,235** shares at December 31, 2024, to **64,060,262** shares at June 30, 2025[7](index=7&type=chunk)[16](index=16&type=chunk) - Additional paid-in capital increased from **$296,217,000** to **$299,318,000**, while retained deficit increased from **$(401,572,000)** to **$(418,761,000)** due to net losses and preferred stock dividends[7](index=7&type=chunk)[16](index=16&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide critical context to the financial statements, detailing the company's business, liquidity challenges, related-party debt, fair value measurements, stock-based compensation, and clinical development activities, highlighting the going concern uncertainty and reliance on future financing [1. Basis of Presentation and Liquidity](index=10&type=section&id=1.%20Basis%20of%20Presentation%20and%20Liquidity) Galectin Therapeutics Inc. is a clinical-stage biopharmaceutical company facing going concern uncertainty due to historical losses and no revenue, despite having $13.8 million cash and a new $10 million credit line to fund operations through June 2026 - The Company is a clinical stage biopharmaceutical company developing therapies for fibrotic disease and cancer by targeting galectin proteins[17](index=17&type=chunk) - The Company has operated at a loss since its inception and has had no revenues, anticipating continued losses[20](index=20&type=chunk) Liquidity Position (in thousands) | Metric | June 30, 2025 | | :-------------------------------- | :------------ | | Unrestricted cash and cash equivalents | $13,771 | | New line of credit (July 8, 2025) | $10,000 | - The Company believes it has sufficient cash, including the new line of credit, to fund planned operations through **June 30, 2026**, but needs to raise additional capital thereafter[20](index=20&type=chunk) [2. Accrued Expenses and Other](index=10&type=section&id=2.%20Accrued%20Expenses%20and%20Other) Accrued expenses decreased significantly from December 31, 2024, to June 30, 2025, primarily due to a reduction in accrued research and development costs and accrued compensation. The company accrues clinical trial expenses based on estimated work completed by CROs Accrued Expenses (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Legal and accounting fees | $71 | $74 | | Accrued compensation | $844 | $1,523 | | Lease liability | $52 | $19 | | Accrued research and development costs | $3,879 | $6,588 | | Total | $4,846 | $8,204 | - Accrued research and development costs decreased by **$2,709,000**, from **$6,588,000** to **$3,879,000**[22](index=22&type=chunk) - Accrued compensation decreased by **$679,000**, from **$1,523,000** to **$844,000**[22](index=22&type=chunk) [3. Convertible Notes Payable – Related Party](index=12&type=section&id=3.%20Convertible%20Notes%20Payable%20%E2%80%93%20Related%20Party) The company has three convertible promissory notes totaling $30 million from a related party (Richard E. Uihlein), all of which had their maturity dates extended to September 30, 2026. These notes bear 2% annual interest and include a contingent interest component recognized as a derivative liability, which has seen significant fair value changes - Three convertible promissory notes (April 2021, September 2021, December 2021), each for **$10,000,000**, were issued by Richard E. Uihlein[24](index=24&type=chunk)[28](index=28&type=chunk)[30](index=30&type=chunk) - All three notes' maturity dates were extended to **September 30, 2026**, in connection with the July 2025 Supplemental Line of Credit[27](index=27&type=chunk)[28](index=28&type=chunk)[30](index=30&type=chunk)[103](index=103&type=chunk) - Contingent interest components of these notes are bifurcated and recognized as derivative liabilities, with fair values increasing significantly from December 31, 2024, to June 30, 2025[26](index=26&type=chunk)[29](index=29&type=chunk)[31](index=31&type=chunk)[34](index=34&type=chunk) [4. Fair Value of Financial Instruments](index=13&type=section&id=4.%20Fair%20Value%20of%20Financial%20Instruments) The company's Level 3 derivative liabilities, primarily contingent interest on convertible notes, increased substantially from December 31, 2024, to June 30, 2025. These are valued using a Monte Carlo Geometric Brownian Stock Path Model, with key assumptions including stock price, term, risk-free rate, credit-adjusted discount rate, and volatility Level 3 Derivative Liabilities (in thousands) | Derivative Liability | June 30, 2025 | December 31, 2024 | | :------------------------------------- | :------------ | :---------------- | | Contingent Interest April Note | $650 | $47 | | Contingent Interest September Note | $298 | $94 | | Contingent Interest December Note | $589 | $275 | | Total | $1,537 | $416 | - The fair value adjustment for the April Note derivative liability was **$603,000** for the six months ended June 30, 2025[35](index=35&type=chunk) - Key valuation assumptions for derivatives include a stock price of **$2.11** at June 30, 2025 (up from **$1.29** at Dec 31, 2024) and volatility ranging from **101%** to **102%**[35](index=35&type=chunk) [5. Stock-Based Compensation](index=16&type=section&id=5.%20Stock-Based%20Compensation) Total stock-based compensation expense decreased for both the three and six months ended June 30, 2025, compared to 2024. Stock option activity included significant grants and exercises, while restricted stock units were issued to employees with vesting tied to a partnership or year-end Stock-Based Compensation Expense (in thousands) | Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $254 | $386 | $530 | $709 | | General and administrative | $246 | $352 | $436 | $633 | | Total stock-based compensation expense | $500 | $738 | $966 | $1,342 | - **1,211,000** stock options were granted during the six months ended June 30, 2025, with a weighted-average grant date fair value of **$0.87**[37](index=37&type=chunk) - **504,000** restricted stock units valued at **$620,000** were issued to employees during the six months ended June 30, 2025, vesting on the earlier of a partnership or December 31, 2025[40](index=40&type=chunk) [6. Common Stock Warrants](index=18&type=section&id=6.%20Common%20Stock%20Warrants) The number of common stock warrants outstanding increased slightly from December 31, 2024, to June 30, 2025, with new grants and some forfeitures. The weighted average exercise price remained stable Common Stock Warrant Activity | Metric | Shares | Weighted Average Exercise Price | | :-------------------------- | :------- | :------------------------------ | | Outstanding, Dec 31, 2024 | 9,595,940| $4.22 | | Granted | 220,000 | $3.00 | | Forfeited/cancelled | (111,510)| $3.00 | | Outstanding, June 30, 2025 | 9,704,430| $4.20 | - The weighted average expiration of warrants outstanding as of June 30, 2025, is **1.6 years**[46](index=46&type=chunk) [7. Loss Per Share](index=18&type=section&id=7.%20Loss%20Per%20Share) Basic and diluted net loss per common share decreased for the six months ended June 30, 2025, compared to 2024. A significant number of potential common shares from warrants, options, convertible notes, and preferred stock were anti-dilutive and thus excluded from diluted EPS calculation Net Loss Per Common Share | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | | Net loss per common share — basic and diluted | $(0.27) | $(0.39) | Anti-Dilutive Shares (shares) | Instrument | June 30, 2025 | June 30, 2024 | | :------------------------------------------------ | :------------ | :------------ | | Warrants to purchase shares of common stock | 9,704,430 | 9,426,853 | | Options to purchase shares of common stock | 7,541,818 | 7,369,758 | | Restricted stock units | 496,520 | 408,000 | | Shares from convertible notes payable – related party | 7,327,374 | 6,721,188 | | Shares from convertible line of credit – related party | 29,621,834 | 21,016,837 | | Shares from preferred stock conversion | 495,007 | 499,174 | | Total Anti-Dilutive Shares | 55,186,983 | 45,441,810 | [8. Common Stock](index=18&type=section&id=8.%20Common%20Stock) The company issued 419,904 shares of common stock under its At Market Issuance Sales Agreement for net proceeds of $1,218,000 during the quarter ended June 30, 2025. Additionally, shares were issued for preferred stock dividends and conversions - **419,904** shares of common stock were issued under the 2020 At Market Agreement for net proceeds of approximately **$1,218,000** during the quarter ended June 30, 2025[49](index=49&type=chunk) - No shares were issued under the 2020 At Market Agreement during the quarter ended June 30, 2024[49](index=49&type=chunk) - **25,000** shares of Series A Convertible Preferred Stock were converted into **4,167** shares of common stock during the three months ended June 30, 2025[50](index=50&type=chunk) [9. Convertible Line of Credit – Related Party and Supplemental Convertible Lines of Credit – Related Party](index=19&type=section&id=9.%20Convertible%20Line%20of%20Credit%20%E2%80%93%20Related%20Party%20and%20Supplemental%20Convertible%20Lines%20of%20Credit%20%E2%80%93%20Related%20Party) The company has multiple convertible lines of credit from a related party, totaling $81 million, with various draws made and associated warrants issued. All maturity dates for these lines of credit were extended to September 30, 2026. Interest rates vary, and the principal and accrued interest are convertible into common stock at the lender's option - The original Line of Credit (July 2022) provided up to **$60 million**, with its maturity extended to **September 30, 2026**[51](index=51&type=chunk)[52](index=52&type=chunk)[103](index=103&type=chunk) - Several promissory notes were executed under this line, each for **$10 million**, with associated warrants issued to the lender[56](index=56&type=chunk)[58](index=58&type=chunk)[60](index=60&type=chunk)[62](index=62&type=chunk)[64](index=64&type=chunk)[66](index=66&type=chunk) - New supplemental lines of credit were established in March 2024 (**$10M**), November 2024 (**$6M**), and March 2025 (**$5M**), with draws made and warrants issued under each[69](index=69&type=chunk)[76](index=76&type=chunk)[82](index=82&type=chunk) - Accrued interest on these lines of credit increased significantly from December 31, 2024, to June 30, 2025, reflecting ongoing borrowings[56](index=56&type=chunk)[58](index=58&type=chunk)[60](index=60&type=chunk)[62](index=62&type=chunk)[64](index=64&type=chunk)[66](index=66&type=chunk)[73](index=73&type=chunk)[80](index=80&type=chunk) [10. Segments](index=24&type=section&id=10.%20Segments) The company operates as a single segment focused on fibrotic disease therapeutics, with no product revenue. The Chief Executive Officer, as CODM, assesses performance based on net loss, net cash used in operating activities, and cash on hand, using cash forecast models for resource allocation - The Company's operations are viewed as one operating segment, focused on creating new therapies for fibrotic disease based on targeting galectin proteins[89](index=89&type=chunk) - The Company has not generated any product revenue and expects to incur significant expenses and operating losses for the foreseeable future[91](index=91&type=chunk) Segment Operating Results (in thousands) | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | | Total operating expenses | $12,522 | $20,939 | | Total operating loss | $(12,522) | $(20,939) | | Net loss | $(17,152) | $(23,860) | | Net cash used in operating activities | $(14,300) | $(20,400) | [11. Commitments and Contingencies](index=25&type=section&id=11.%20Commitments%20and%20Contingencies) The company has no significant pending legal proceedings and accrues for contingencies when probable and estimable. Clinical trial and research commitments are generally cancellable with 30 days' notice, and the company is negotiating with a contract vendor for clinical trial management services - There are no significant pending legal proceedings[98](index=98&type=chunk) - Agreements with contractors for R&D activities are generally cancellable with **thirty days' notice**[99](index=99&type=chunk) - The Company has accrued its estimate of the amount owed to a contract vendor for clinical trial management services[99](index=99&type=chunk) [12. Leases](index=26&type=section&id=12.%20Leases) The company has one operating lease for office space, renewed in March 2025 for twelve months. The lease liability and right-to-use asset are $52,000 as of June 30, 2025 - The Company renewed its office space lease in March 2025 for **twelve months**, effective March 1, 2022[100](index=100&type=chunk) Operating Lease Maturity (in thousands) | Year | Amount | | :--- | :----- | | 2025 | $33 | | 2026 | $22 | | Total| $55 | | Less imputed interest | $(3) | | Present value of lease liability | $52 | - The discount rate used for lease payments is **14%**[101](index=101&type=chunk) [13. Galectin Sciences LLC](index=26&type=section&id=13.%20Galectin%20Sciences%20LLC) Galectin Therapeutics Inc. co-owns Galectin Sciences LLC, a joint venture for galectin-3 inhibitor research. The company's ownership increased to 85.4% as of June 30, 2025, due to disproportionate funding contributions, and it accounts for the LLC as a consolidated, less than wholly owned subsidiary - Galectin Sciences LLC is a collaborative joint venture co-owned by SBH Sciences, Inc., focused on researching and developing small organic molecule inhibitors of galectin-3[102](index=102&type=chunk) - As of June 30, 2025, the Company's ownership percentage in the LLC was **85.4%**, up from an initial **50%**, due to providing more funding[102](index=102&type=chunk) - The Company has contributed a total of **$4,166,000** to the LLC cumulatively as of June 30, 2025[102](index=102&type=chunk) [14. Subsequent Event](index=26&type=section&id=14.%20Subsequent%20Event) On July 8, 2025, the company secured a new $10 million Supplemental Line of Credit from its chairman, Richard E. Uihlein, extending the maturity dates of all existing convertible notes and lines of credit to September 30, 2026. This new line also includes the issuance of warrants to the lender - On July 8, 2025, the Company entered into a new **$10 million** Supplemental Line of Credit with Richard E. Uihlein[103](index=103&type=chunk) - The maturity dates of all Convertible Notes Payable – Related Party and all borrowings under Convertible Lines of Credit – Related Party were extended to **September 30, 2026**[103](index=103&type=chunk) - In connection with this new line, the Company agreed to issue warrants to purchase up to **200,000** shares of common stock to the lender[106](index=106&type=chunk)[107](index=107&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and operations, focusing on its clinical-stage drug development, particularly belapectin for NASH and cancer, and financial performance for Q2 2025, including R&D, G&A, and liquidity [Overview](index=29&type=section&id=Overview) Galectin Therapeutics is a clinical-stage biopharmaceutical company developing therapies for fibrotic diseases and cancer by targeting galectin proteins, particularly galectin-3. Its lead candidate, belapectin, is in development for NASH cirrhosis (NAVIGATE trial results presented) and cancer immunotherapy (Phase 2 trial planned for head and neck cancer) - The company is a clinical stage biopharmaceutical company focused on developing new therapies for fibrotic disease, cancer, and other conditions by targeting galectin proteins[112](index=112&type=chunk) - Belapectin (GR-MD-02) is the lead galectin-3 inhibitor, demonstrated in preclinical models to reverse liver fibrosis and cirrhosis, and in clinical studies to decrease portal hypertension[113](index=113&type=chunk) - Top-line results from the NAVIGATE Phase 2b/3 clinical trial for NASH cirrhosis showed a **49.3%** reduction in varices incidence in the per-protocol population (p<0.05) and a **68.1%** reduction in U.S. completer patients (p=0.02) for the belapectin **2 mg/kg** dose group[115](index=115&type=chunk)[140](index=140&type=chunk) - A Phase 2 trial for advanced or metastatic head and neck cancer using belapectin in combination with a checkpoint inhibitor is planned, pending financing[121](index=121&type=chunk)[152](index=152&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) Operating expenses decreased significantly for both the three and six months ended June 30, 2025, compared to 2024, primarily driven by a substantial reduction in research and development expenses due to the conclusion of the NAVIGATE clinical trial. General and administrative expenses also saw a modest decrease Operating Expenses (in thousands) | Expense Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | % Change | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | % Change | | :----------------------- | :--------------------------- | :--------------------------- | :------- | :--------------------------- | :--------------------------- | :------- | | Research and development | $3,261 | $9,813 | -67% | $9,746 | $17,867 | -45% | | General and administrative | $1,364 | $1,478 | -8% | $2,776 | $3,072 | -10% | | Total operating expenses | $4,625 | $11,291 | -59% | $12,522 | $20,939 | -40% | - The decrease in research and development expenses is primarily due to lower expenses related to the NAVIGATE clinical trial, which ended in the first quarter of 2025[155](index=155&type=chunk) - General and administrative expenses decreased due to lower stock compensation expense and investor relations/business development expense[158](index=158&type=chunk) [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) The company's cash and cash equivalents stood at $13.8 million as of June 30, 2025, supplemented by a new $10 million line of credit, which is expected to fund operations through June 30, 2026. Net cash used in operations decreased, but cash provided by financing activities also declined, indicating a continued need for future capital Liquidity and Cash Flow (in thousands) | Metric | June 30, 2025 | June 30, 2024 | | :------------------------------------- | :------------ | :------------ | | Cash and cash equivalents | $13,800 | $25,600 | | Net cash used in operations (6 months) | $(14,291) | $(20,438) | | Cash from financing activities (6 months) | $12,942 | $20,376 | - The Company had **$13.8 million** in unrestricted cash and cash equivalents at June 30, 2025, and secured a new **$10 million** line of credit in July 2025[159](index=159&type=chunk) - Management believes current cash and available credit are sufficient to fund operations through **June 30, 2026**, but additional financing will be required thereafter[159](index=159&type=chunk) [Off-Balance Sheet Arrangements](index=39&type=section&id=Off-Balance%20Sheet%20Arrangements) The company has no off-balance sheet arrangements that are reasonably likely to materially affect its liquidity or capital resources - The Company has not created, and is not a party to, any special-purpose or off-balance sheet entities[161](index=161&type=chunk) [Application of Critical Accounting Policies and Estimates](index=39&type=section&id=Application%20of%20Critical%20Accounting%20Policies%20and%20Estimates) The preparation of financial statements requires significant estimates and judgments, particularly concerning accrued expenses, stock-based compensation, and contingencies. Critical accounting policies include stock-based compensation, accrued expenses, and income taxes - Critical accounting policies include stock-based compensation, accrued expenses, and income taxes[163](index=163&type=chunk) - Estimates are based on historical experience, contract terms, industry trends, and other factors, with actual results potentially differing under various assumptions[162](index=162&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures about Market Risk](index=39&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk exposure is to changes in U.S. interest rates. However, due to its short-term investments in operating bank accounts and money market funds, the company believes it is not subject to any material market risk - The primary market risk is the risk of loss due to changes in U.S. interest rates[164](index=164&type=chunk) - The Company maintains its cash and cash equivalents in operating bank accounts and money market funds[164](index=164&type=chunk) - Due to the short-term duration of investments, the Company believes it is not subject to any material market risk exposure[164](index=164&type=chunk) [ITEM 4. Controls and Procedures](index=40&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2025. No material changes in internal control over financial reporting occurred during the quarter - Disclosure controls and procedures were evaluated and deemed effective as of **June 30, 2025**[165](index=165&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[167](index=167&type=chunk) - Management acknowledges that no control system can provide absolute assurance against all errors and fraud[166](index=166&type=chunk) [PART II — OTHER INFORMATION](index=40&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) [ITEM 1. Legal Proceedings](index=40&type=section&id=ITEM%201.%20Legal%20Proceedings) There are no significant pending legal proceedings to report - No significant pending legal proceedings are reported[169](index=169&type=chunk) [ITEM 1A. Risk Factors](index=40&type=section&id=ITEM%201A.%20Risk%20Factors) The company refers readers to the comprehensive list of risk factors detailed in its Annual Report on Form 10-K for the year ended December 31, 2024, which could materially impact its business, financial condition, or future results - Readers are directed to the risk factors in the Annual Report on Form 10-K for the year ended December 31, 2024[170](index=170&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report - No unregistered sales of equity securities or use of proceeds to report[171](index=171&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=40&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report - No defaults upon senior securities to report[171](index=171&type=chunk) [ITEM 4. Mine Safety Disclosures](index=40&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine Safety Disclosures are not applicable[171](index=171&type=chunk) [ITEM 5. Other Information](index=40&type=section&id=ITEM%205.%20Other%20Information) The company announced its 2025 Annual Meeting of Stockholders will be a virtual meeting on December 3, 2025, and provided updated deadlines for stockholder proposals and nominations. Additionally, all three executive officers adopted Rule 10b5-1 trading arrangements during the quarter - The 2025 Annual Meeting of Stockholders is scheduled for **December 3, 2025**, as a virtual meeting[171](index=171&type=chunk) - Stockholder proposals for inclusion in the proxy statement must be received by **September 1, 2025**[173](index=173&type=chunk) - All three executive officers adopted Rule 10b5-1 trading arrangements during the fiscal quarter ended June 30, 2025[176](index=176&type=chunk) [ITEM 6. Exhibits](index=41&type=section&id=ITEM%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications, XBRL taxonomy documents, and the interactive data file - Exhibits include Certifications Pursuant to Rule 13a-14(a) and 18 U.S.C. Section 1350[177](index=177&type=chunk) - Inline XBRL Instance Document and Taxonomy Extension Documents are also included[177](index=177&type=chunk)[178](index=178&type=chunk) [SIGNATURES](index=43&type=section&id=SIGNATURES) The report is duly signed on behalf of Galectin Therapeutics Inc. by Joel Lewis, Chief Executive Officer and President, and Jack W. Callicutt, Chief Financial Officer, on August 14, 2025 - The report was signed by Joel Lewis, Chief Executive Officer and President, and Jack W. Callicutt, Chief Financial Officer[183](index=183&type=chunk) - The signing date for the report was **August 14, 2025**[182](index=182&type=chunk)

Corporate Update and Highlights [Management Commentary](index=1&type=section&id=Management%20Commentary) The CEO highlights FDA clearance for the NurOwn Phase 3b trial as a key milestone and affirms the company's clinical execution focus - Reached a key milestone in Q2 with **FDA clearance** to initiate the Phase 3b trial for NurOwn, designed to support a potential Biologics License Application (BLA) submission[2](index=2&type=chunk) - Advancing operational activities, including discussions with clinical sites and engagement with CDMO partners to ensure readiness for clinical drug supply[2](index=2&type=chunk) - Supports the FDA's consideration of the Citizen Petition, viewing it as a potential opportunity for a fresh, objective evaluation of NurOwn's scientific evidence[2](index=2&type=chunk) [Recent Highlights](index=1&type=section&id=Recent%20Highlights) The company received FDA clearance for its Phase 3b trial, saw a Citizen Petition filed, and reported positive EAP survival data - The FDA has cleared the company to initiate the Phase 3b clinical trial of NurOwn, known as ENDURANCE, expected to enroll **approximately 200 participants**[3](index=3&type=chunk) - A Citizen Petition was submitted to the FDA by the ALS Community, requesting a new review of the NurOwn data, which the company believes provides a new opportunity to reaffirm NurOwn's potential[7](index=7&type=chunk) - New survival data from the NurOwn Expanded Access Program (EAP) showed that **100% of participants (10/10) survived more than 5 years** from the onset of ALS symptoms[7](index=7&type=chunk) - BrainStorm signed a Letter of Intent (LOI) with Minaris Advanced Therapies, a global CDMO, to manufacture NurOwn for the upcoming Phase 3b clinical trial[7](index=7&type=chunk) - New pharmacogenomic data highlighting the impact of the UNC13A genotype on clinical outcomes were selected for presentation at the ISCT 2025 Annual Meeting[7](index=7&type=chunk) Financial Performance [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reported a net loss of $2.9 million for Q2 2025, with increased R&D expenses and decreased G&A expenses Q2 2025 Financial Highlights | Financial Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, and restricted cash | ~$1.03 million | N/A | | Research and development expenditures, net | $1.1 million | $0.9 million | | General and administrative expenses | ~$1.4 million | ~$2.1 million | | Net loss | ~$2.9 million | ~$2.5 million | | Net loss per share | $0.34 | $0.60 | [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) The statements show total assets of $2.57 million, a stockholders' deficit of $6.06 million, and a Q2 net loss of $2.90 million [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets increased to $2.57 million while the total stockholders' deficit improved to $6.06 million Financial Position Comparison | Balance Sheet Item (in thousands) | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :--- | :--- | :--- | | Cash and cash equivalents | $824 | $187 | | Total current assets | $1,515 | $385 | | Total assets | $2,566 | $1,832 | | Total current liabilities | $8,528 | $8,978 | | Total liabilities | $8,623 | $9,596 | | Total stockholders' deficit | $(6,057) | $(7,764) | [Consolidated Statements of Comprehensive Loss](index=6&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) The company recorded a net loss of $2.90 million for Q2 2025 and $5.77 million for the six months ended June 30, 2025 Three Months Ended June 30 | Statement of Loss (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development, net | $1,120 | $922 | | General and administrative | $1,453 | $2,060 | | Operating loss | $(2,573) | $(2,982) | | Net loss | $(2,903) | $(2,541) | | Basic and diluted net loss per share | $(0.34) | $(0.60) | Six Months Ended June 30 | Statement of Loss (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development, net | $2,424 | $1,883 | | General and administrative | $3,238 | $3,573 | | Operating loss | $(5,662) | $(5,456) | | Net loss | $(5,767) | $(5,942) | | Basic and diluted net loss per share | $(0.77) | $(1.35) | Company and Product Overview [About NurOwn®](index=3&type=section&id=About%20NurOwn%C2%AE) NurOwn® is an investigational autologous stem cell therapy designed to deliver neurotrophic factors to sites of damage - The NurOwn® technology platform uses **autologous MSC-NTF cells** produced from a patient's own bone marrow-derived mesenchymal stem cells (MSCs)[8](index=8&type=chunk) - MSCs are converted into MSC-NTF cells, which are induced to secrete high levels of **neurotrophic factors (NTFs)**[8](index=8&type=chunk) - The therapy aims to deliver NTFs and immunomodulatory cytokines to the site of damage to slow or stabilize disease progression[8](index=8&type=chunk) [About BrainStorm Cell Therapeutics Inc.](index=3&type=section&id=About%20BrainStorm%20Cell%20Therapeutics%20Inc.) BrainStorm is a clinical-stage biotech company developing autologous stem cell therapies for neurodegenerative diseases - BrainStorm is a leading developer of **autologous adult stem cell therapies** for debilitating neurodegenerative diseases[9](index=9&type=chunk) - The lead investigational therapy, NurOwn®, has completed a Phase 3 trial in ALS and is set to launch a **Phase 3b trial** under a Special Protocol Assessment (SPA) with the FDA[10](index=10&type=chunk) - The company is also advancing a proprietary, **allogeneic exosome-based platform** and recently received a Notice of Allowance for a foundational patent[10](index=10&type=chunk) Other Information [Conference Call Information](index=2&type=section&id=Conference%20Call%20Information) The company held a conference call on August 14, 2025, to discuss Q2 results, with a replay available until August 28 - A conference call and webcast were scheduled for **8:30 a.m. Eastern Time on Thursday, August 14, 2025**[1](index=1&type=chunk)[5](index=5&type=chunk) - A replay of the conference call will be available until **August 28**[5](index=5&type=chunk)[6](index=6&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section cautions that the press release contains forward-looking statements subject to substantial risks and uncertainties - The press release contains forward-looking statements regarding the clinical development of NurOwn, potential regulatory approval, and the future success of the company[11](index=11&type=chunk) - These statements are subject to inherent uncertainties, risks, and assumptions that are difficult to predict, including the ability to **raise additional capital** and continue as a going concern[11](index=11&type=chunk)