Part I Financial Information [Financial Statements](index=9&type=section&id=Item%201.%20Financial%20Statements) Xilio's June 30, 2025, financials show increased cash and liabilities, a $29.1 million net loss, and significant going concern doubts [Condensed Consolidated Balance Sheets](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $121,551 | $55,291 | | Total current assets | $123,716 | $60,234 | | Total assets | $133,813 | $71,075 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $53,260 | $27,261 | | Common stock warrant liabilities | $38,550 | $0 | | Total liabilities | $126,744 | $53,477 | | Accumulated deficit | $(412,862) | $(383,753) | | Total stockholders' equity | $7,069 | $17,598 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Summary (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration and license revenue | $8,084 | $2,357 | $11,014 | $2,357 | | Research and development | $15,330 | $11,216 | $23,596 | $21,616 | | General and administrative | $7,120 | $5,815 | $15,635 | $11,954 | | Total operating expenses | $22,450 | $17,061 | $39,231 | $34,548 | | Loss from operations | $(14,366) | $(14,704) | $(28,217) | $(32,191) | | Net loss | $(15,844) | $(13,925) | $(29,109) | $(31,128) | | Net loss per share, basic and diluted | $(0.16) | $(0.24) | $(0.34) | $(0.73) | [Condensed Consolidated Statements of Cash Flows](index=13&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | $14,501 | $9,451 | | Net cash used in investing activities | $(423) | $(21) | | Net cash provided by financing activities | $52,194 | $20,997 | | **Increase in cash, cash equivalents and restricted cash** | **$66,272** | **$30,427** | [Notes to Condensed Consolidated Financial Statements](index=15&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The company has incurred significant operating losses, with a **net loss of $29.1 million** for the six months ended June 30, 2025, and an **accumulated deficit of $412.9 million**, raising substantial doubt about its ability to continue as a going concern[33](index=33&type=chunk) - To fund operations, the company will need to raise additional capital through warrant exercises, milestone payments from Gilead and AbbVie, equity/debt financings, or other collaborations, with potential cost reduction strategies if capital is not secured[34](index=34&type=chunk) - In February 2025, the company entered a collaboration with AbbVie for up to four programs, receiving an initial **$52.0 million** ($42.0 million upfront cash and $10.0 million from a private placement) and is eligible for up to approximately **$2.1 billion** in additional contingent payments[55](index=55&type=chunk)[61](index=61&type=chunk) - In March 2024, the company entered a license agreement with Gilead for its XTX301 (IL-12) program, receiving **$55.0 million** ($30.0 million upfront cash and $25.0 million from private placements) and is eligible for up to **$592.5 million** in additional contingent payments, including a **$75.0 million** transition fee[72](index=72&type=chunk)[74](index=74&type=chunk) - In June 2025, the company closed a follow-on public offering of prefunded warrants and accompanying common stock warrants, receiving initial gross proceeds of **$50.0 million**, with potential for an additional **$100.0 million** if certain warrants are exercised for cash by the second half of 2026[32](index=32&type=chunk)[89](index=89&type=chunk)[96](index=96&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=43&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management reports Xilio, a clinical-stage biotech, has $121.6 million cash, funding through Q3 2026, but faces going concern doubts and needs more capital [Overview](index=43&type=section&id=Overview) - Xilio is a clinical-stage biotechnology company developing tumor-activated immuno-oncology (I-O) therapies to improve outcomes for cancer patients while minimizing systemic side effects[123](index=123&type=chunk) - The company's most advanced product candidates are vilastobart (anti-CTLA-4 mAb) and XTX301 (engineered IL-12), with vilastobart in a Phase 2 trial and XTX301 in a Phase 1 trial under a license agreement with Gilead[123](index=123&type=chunk) - The company is also advancing preclinical programs, including XTX501 (masked PD-1/IL-2 bispecific) and masked T cell engagers, partly in collaboration with AbbVie[123](index=123&type=chunk) [Results of Operations](index=53&type=section&id=Results%20of%20Operations) Comparison of Results for the Three Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration and license revenue | $8,084 | $2,357 | $5,727 | | Research and development | $15,330 | $11,216 | $4,114 | | General and administrative | $7,120 | $5,815 | $1,305 | | **Net loss** | **$(15,844)** | **$(13,925)** | **$(1,919)** | Comparison of Results for the Six Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration and license revenue | $11,014 | $2,357 | $8,657 | | Research and development | $23,596 | $21,616 | $1,980 | | General and administrative | $15,635 | $11,954 | $3,681 | | **Net loss** | **$(29,109)** | **$(31,128)** | **$2,019** | - The increase in collaboration revenue for both the three and six-month periods in 2025 was primarily due to revenue recognized under the new agreement with AbbVie and increased revenue from the Gilead agreement[147](index=147&type=chunk)[155](index=155&type=chunk) - R&D expenses increased in Q2 2025 due to higher clinical development costs for vilastobart and manufacturing activities for XTX501, partially offset by the discontinuation of the XTX202 program[148](index=148&type=chunk) [Liquidity and Capital Resources](index=60&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company had **cash and cash equivalents of $121.6 million**[165](index=165&type=chunk)[178](index=178&type=chunk) - Management anticipates that existing cash will be sufficient to fund operating expenses and capital expenditure requirements through the end of the **third quarter of 2026**[178](index=178&type=chunk) - The company's recurring operating losses and negative cash flows raise substantial doubt about its ability to continue as a going concern, with future operations dependent on raising additional capital through warrant exercises, milestone payments, or other financing activities[178](index=178&type=chunk) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | $14,501 | $9,451 | | Net cash used in investing activities | $(423) | $(21) | | Net cash provided by financing activities | $52,194 | $20,997 | [Quantitative and Qualitative Disclosures About Market Risk](index=70&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is not required to provide this information - As a smaller reporting company defined by Rule 12b-2 of the Exchange Act, Xilio Therapeutics is not required to provide the information under this item[191](index=191&type=chunk) [Controls and Procedures](index=70&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2025, with no material changes to internal control - The company's principal executive officer and principal financial officer evaluated the effectiveness of disclosure controls and procedures as of June 30, 2025, and concluded they were effective at a reasonable assurance level[193](index=193&type=chunk) - There were no changes in the company's internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, these controls[194](index=194&type=chunk) Part II Other Information [Risk Factors](index=71&type=section&id=Item%201A.%20Risk%20Factors) Xilio faces substantial risks including going concern doubts, potential delisting, unproven early-stage products, clinical/manufacturing challenges, third-party reliance, and IP/regulatory hurdles [Risks Related to Financial Position and Capital Requirements](index=71&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History,%20Financial%20Position%20and%20Capital%20Requirements) - Recurring losses from operations raise substantial doubt about the company's ability to continue as a going concern, potentially requiring cost reduction strategies like delaying or reducing R&D programs without additional capital[198](index=198&type=chunk)[199](index=199&type=chunk) - The company's common stock may be delisted from Nasdaq for failing to meet the minimum bid price requirement of **$1.00 per share**, which could negatively impact its ability to access capital markets[206](index=206&type=chunk) - The company has a history of significant operating losses, with an **accumulated deficit of $412.9 million** as of June 30, 2025, and expects these losses to continue for the foreseeable future[212](index=212&type=chunk) [Risks Related to Product Discovery and Development](index=81&type=section&id=Risks%20Related%20to%20the%20Discovery%20and%20Development%20of%20Our%20Product%20Candidates) - The company's business is highly dependent on the success of its current product candidates (vilastobart and XTX301), which are in early stages of development and require significant additional clinical work[224](index=224&type=chunk) - The company's technological approach to discovering and developing tumor-activated product candidates is unproven, with no guarantee it will lead to commercially valuable products[265](index=265&type=chunk) - Clinical trials may be substantially delayed, suspended, or terminated due to numerous unforeseen events, including regulatory hurdles, patient enrollment difficulties, and unfavorable results[239](index=239&type=chunk) - Interim and preliminary data from clinical trials may change as more patient data becomes available, and final data could be materially different[253](index=253&type=chunk) [Risks Related to Manufacturing and Supply](index=100&type=section&id=Risks%20Relating%20to%20Manufacturing%20and%20Supply) - Manufacturing biologics is complex and subject to problems like contamination or lot failures, which could delay development and commercialization programs[273](index=273&type=chunk)[276](index=276&type=chunk) - The company relies on a single CDMO, WuXi Biologics, based in China, exposing it to risks related to supply interruptions, regulatory compliance, and geopolitical tensions, including potential U.S. trade restrictions or sanctions[280](index=280&type=chunk)[285](index=285&type=chunk)[516](index=516&type=chunk) [Risks Related to Dependence on Third Parties](index=108&type=section&id=Risks%20Related%20to%20our%20Dependence%20on%20Third%20Parties) - The company relies on third-party CROs to conduct clinical trials, and their unsatisfactory performance could harm the business and delay programs[291](index=291&type=chunk)[292](index=292&type=chunk) - Success is dependent on collaborations with Gilead and AbbVie, where partners have significant discretion over development and commercialization, with no guarantee of success or future payments[295](index=295&type=chunk)[297](index=297&type=chunk) [Risks Related to Intellectual Property](index=124&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - The company's success depends on its ability to obtain and maintain patent protection, as insufficient scope could allow competitors to develop similar products, adversely affecting commercialization[338](index=338&type=chunk)[339](index=339&type=chunk) - The company relies on in-licensed patent rights for its product candidates (e.g., from City of Hope and WuXi Biologics) and faces risks of losing these rights if it fails to comply with license obligations[359](index=359&type=chunk)[360](index=360&type=chunk) - The company may face third-party claims of intellectual property infringement, which could be expensive, time-consuming, and prevent or delay development efforts[384](index=384&type=chunk) [Risks Related to Regulatory Approval and Legal Compliance](index=152&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20and%20Other%20Legal%20Compliance%20Matters) - The regulatory approval process for biologics is expensive, lengthy, and uncertain, and the company, lacking experience in filing for marketing approval, may be unable to obtain it for its product candidates[411](index=411&type=chunk)[412](index=412&type=chunk) - Disruptions at the FDA and other government agencies due to funding cuts, shutdowns, or other events could hinder their ability to provide guidance and review submissions in a timely manner[423](index=423&type=chunk) - Current and future healthcare legislation, such as the Inflation Reduction Act (IRA), may increase the difficulty and cost of obtaining reimbursement and limit the prices for the company's products if approved[464](index=464&type=chunk)[476](index=476&type=chunk) - The company is subject to stringent and evolving data privacy laws (e.g., GDPR, CCPA), and failure to comply could result in significant fines and penalties[492](index=492&type=chunk)[498](index=498&type=chunk) [Other Information](index=211&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter - No directors or officers adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025[582](index=582&type=chunk) [Exhibits](index=212&type=section&id=Item%206.%20Exhibits) This section lists key exhibits filed with the Form 10-Q, including corporate documents and officer certifications - The Exhibit Index lists key corporate and financial documents filed with the report, such as the Restated Certificate of Incorporation, Warrant Agreements, and Officer Certifications pursuant to the Sarbanes-Oxley Act[585](index=585&type=chunk)

Exhibit 99.1 MeiraGTx Reports Second Quarter 2025 Financial and Operational Results - Gained alignment with U.S. Food and Drug Administration (FDA) on the ongoing Phase 2 AQUAx2 randomized double-blind, placebo-controlled pivotal study in Grade 2/3 radiation-induced xerostomia (RIX) to support a potential Biologics License Application (BLA) filing; on track for potential data readout late 2026 - FDA Granted Regenerative Medicine Advanced Therapy (RMAT) designation for AAV-GAD for the treatment of Parkinson' ...

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited financial statements for Q2 2025 reflect a significant performance downturn, resulting in a net loss, reduced cash, and substantial doubt about the company's ability to continue as a going concern [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) As of June 30, 2025, total assets decreased to **$49.99 million** from **$54.70 million**, primarily due to a significant drop in cash, while stockholders' equity also declined Condensed Balance Sheet Highlights (in thousands) | Account | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $959 | $3,723 | | Total current assets | $22,800 | $25,076 | | Total assets | $49,985 | $54,696 | | Total current liabilities | $5,384 | $7,365 | | Total liabilities | $21,415 | $22,708 | | Total stockholders' equity | $28,571 | $31,988 | [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations) For Q2 and H1 2025, revenues plummeted, leading to significant net losses of **$4.19 million** and **$6.76 million** respectively, a sharp reversal from prior year's net income Three Months Ended June 30, Performance Comparison (in millions, except EPS) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Revenues | $1.86 | $15.65 | -88.1% | | Gross Profit (Loss) | ($0.13) | $9.01 | -101.4% | | Net Income (Loss) | ($4.19) | $3.34 | -225.5% | | Diluted EPS | ($0.36) | $0.29 | -224.1% | Six Months Ended June 30, Performance Comparison (in millions, except EPS) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Revenues | $4.33 | $27.05 | -84.0% | | Gross Profit | $0.97 | $13.64 | -92.9% | | Net Income (Loss) | ($6.76) | $3.85 | -275.7% | | Diluted EPS | ($0.59) | $0.41 | -243.9% | [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For H1 2025, net cash decreased by **$2.76 million** due to significant cash usage in operations and investing, a stark reversal from the **$11.96 million** increase in H1 2024 driven by financing Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,515) | $(940) | | Net cash used in investing activities | $(249) | $(2,228) | | Net cash provided by financing activities | $0 | $15,131 | | **Net Change in Cash** | **$(2,764)** | **$11,963** | [Notes to the Condensed Financial Statements](index=9&type=section&id=Notes%20to%20the%20Condensed%20Financial%20Statements) Key notes reveal substantial doubt about going concern due to net losses and low cash, highlight high customer concentration, significant related-party debt restructuring, and a complete pivot to freeze-dried candy products - The company has raised substantial doubt about its ability to continue as a going concern, citing an accumulated deficit of **$69.2 million**, a net loss of **$6.8 million** for the six-month period, and a cash balance of only **$959,416** as of June 30, 2025[66](index=66&type=chunk) - Management's plans to address the going concern issue include debt restructuring (completed in Q2 2025), cost-cutting, entering new overseas markets, and exploring potential partnerships, asset sales, or capital raises[67](index=67&type=chunk)[69](index=69&type=chunk) - The company has significant customer concentration risk, with its top three customers accounting for **48%**, **17%**, and **9%** of revenues for the six months ended June 30, 2025[48](index=48&type=chunk) - In April 2025, the company restructured **$2.5 million** in outstanding promissory notes held by related parties into new senior convertible notes maturing April 30, 2030, reclassifying the debt from current to long-term liabilities[71](index=71&type=chunk)[109](index=109&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 attributes the severe H1 2025 revenue decline and gross profit collapse to intense competitive pressure and customer loss, leading to deteriorated liquidity and reinforcing substantial doubt about the company's going concern ability [Overview and Key Factors](index=26&type=section&id=Overview%20and%20Key%20Factors) Sow Good, a freeze-dried candy manufacturer, faces significant competitive challenges from larger players impacting customer retention, market access, and revenue, alongside supply chain risks - The company operates in a highly competitive industry and has lost significant customers due to competitors using their market status and marketing spend to limit Sow Good's access to shelf space[159](index=159&type=chunk) - As of June 30, 2025, the company's products are sold in approximately **5,000** retail outlets in the U.S. and it has expanded distribution to the Middle East[151](index=151&type=chunk)[155](index=155&type=chunk) - Operational challenges, such as extreme summer heat in 2024, have previously disrupted transportation, increased inventory levels, and negatively impacted revenue and market reputation[163](index=163&type=chunk)[164](index=164&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Operations analysis reveals a dramatic downturn for Q2 and H1 2025, with revenues plummeting by **88%** and **84%** respectively, leading to significant gross losses primarily due to reduced demand and competitive pressure Comparison of Three Months Ended June 30 | Metric | 2025 | 2024 | % Change | | :--- | :--- | :--- | :--- | | Revenues | $1.86M | $15.65M | -88% | | Gross Profit (Loss) | ($0.13M) | $9.01M | -101% | | Net Operating (Loss) Income | ($4.07M) | $4.89M | -183% | Comparison of Six Months Ended June 30 | Metric | 2025 | 2024 | % Change | | :--- | :--- | :--- | :--- | | Revenues | $4.33M | $27.05M | -84% | | Gross Profit | $0.97M | $13.64M | -93% | | Net Operating (Loss) Income | ($6.49M) | $5.81M | -212% | [Liquidity, Going Concern and Capital Resources](index=32&type=section&id=Liquidity,%20Going%20Concern%20and%20Capital%20Resources) The company's liquidity is precarious with cash at **$959.4 thousand**, insufficient for the next twelve months, reinforcing substantial doubt about its going concern ability and necessitating additional financing - As of June 30, 2025, the company had only **$959.4 thousand** in cash and cash equivalents, a decrease of **$2.8 million** since December 31, 2024[199](index=199&type=chunk) - Management explicitly states that the company may not have sufficient funds to sustain operations for the next twelve months, which raises substantial doubt about its ability to continue as a going concern[199](index=199&type=chunk) - In April 2025, the company restructured **$2.7 million** of outstanding current debt into long-term convertible notes maturing in 2030, improving its short-term liquidity profile on paper[200](index=200&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company reports minimal commodity price and interest rate risks but anticipates increasing foreign currency risk with expanding international operations in Mexico, Colombia, and China - The company does not expect significant effects from commodity price risk or interest rate risk[213](index=213&type=chunk)[214](index=214&type=chunk) - Foreign currency risk is expected to increase as the company's foreign operations in markets like Mexico, Colombia, and China grow[215](index=215&type=chunk) [Item 4. Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) As of June 30, 2025, management concluded that disclosure controls and procedures are effective, with no material changes to internal control over financial reporting during the period - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[216](index=216&type=chunk) - No material changes to the company's internal control over financial reporting occurred during the six months ended June 30, 2025[217](index=217&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company is not a party to any legal proceedings expected to have a material adverse effect on its financial condition or operations - The company is not currently involved in any material legal proceedings[220](index=220&type=chunk) [Item 1A. Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) This section highlights critical risks including substantial doubt about going concern, potential Nasdaq delisting due to minimum bid price non-compliance, and adverse impacts from significant tariffs - There is substantial doubt about the company's ability to continue as a going concern, as its cash of **$959.4 thousand** is not sufficient to fund operations for the next twelve months[222](index=222&type=chunk) - On May 14, 2025, the company received a non-compliance notice from Nasdaq for its stock's closing bid price being below **$1.00** for 30 consecutive trading days, with a compliance deadline of November 10, 2025[223](index=223&type=chunk) - The company faces risks from potential significant tariffs, which could materially increase costs, reduce margins, and disrupt the sourcing of raw materials[221](index=221&type=chunk) [Item 2. 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) The company reported no unregistered sales of equity securities during the period - None[229](index=229&type=chunk) [Item 5. Other Information](index=37&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated any Rule 10b5-1 trading plans or other non-Rule 10b5-1 trading arrangements during the period - No directors or officers adopted or terminated any Rule 10b5-1 trading plans[232](index=232&type=chunk) [Item 6. Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including CEO and CFO certifications and incorporated by reference documents

Exhibit 99.1 Research and Development Expenses: Research and development expenses were $7.0 million for the second quarter of 2025 compared to $5.0 million for the second quarter of 2024. The increase was primarily due to an increase in manufacturing costs in support of the Company's CAN- 2409 programs, partially offset by a decrease in employee-related expenses, which was driven primarily from a reduction in stock-based compensation expense. Research and development expenses included a non-cash stock compe ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended June 30, 2025. ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. Commission file number: 001-35376 OBLONG, INC. (Exact Name of Registrant as Specified in its Charter) (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Id ...

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: 001-42374 SYNERGY CHC CORP. (Exact name of registrant as specified in its charter ...

Exhibit 99.1 VYNE Therapeutics Announces Topline Results from Phase 2b Trial with Repibresib Gel in Nonsegmental Vitiligo Trial Did Not Meet Primary Endpoint or Key Secondary Endpoint of F-VASI50 and F-VASI75 Nominally Statistically Significant Ef ects Observed in Key Secondary and Exploratory Endpoints of Change from Baseline in F-VASI and T-VASI at 3% Concentration Company Will Terminate Extension Phase of Trial and Seek External Partner for Continued Development of Repibresib BRIDGEWATER, N.J., July 30, ...

[Sow Good Reports Second Quarter 2025 Results](index=1&type=section&id=Sow%20Good%20Reports%20Second%20Quarter%202025%20Results) Sow Good's Q2 2025 results reflect operational stabilization and strong demand despite temporary revenue impacts from production delays and increased competition [Management Commentary](index=1&type=section&id=Management%20Commentary) Management highlights operational stabilization and strong demand in Q2 2025, despite temporary revenue impacts from production delays and labor shortages - Operations have stabilized, but revenue was temporarily impacted by production delays and labor shortages, even as demand accelerated[3](index=3&type=chunk) - The company deepened partnerships with key retailers like Five Below and Albertsons, expanding both SKU counts and order volumes[3](index=3&type=chunk) - Sow Good successfully launched in the UAE, with results exceeding expectations, validating global demand for its products[3](index=3&type=chunk) - The company's forward-looking strategy focuses on disciplined execution, cost optimization, innovation, and reaccelerating growth in the second half of 2025[3](index=3&type=chunk) [Second Quarter 2025 Highlights](index=1&type=section&id=Second%20Quarter%202025%20Highlights) Sow Good's financial performance declined significantly in the second quarter of 2025 compared to the same period in 2024, driven by reduced revenue and a shift to net loss Q2 2025 Financial Highlights vs. Q2 2024 | Metric | Q2 2025 (USD) | Q2 2024 (USD) | | :--- | :--- | :--- | | **Revenue** | $1.9 million | $15.6 million | | **Gross Profit (Loss)** | $(0.1) million | $9.0 million | | **Gross Margin** | (7%) | 58% | | **Operating Expenses** | $3.9 million | $4.1 million | | **Net Income (Loss)** | $(4.2) million | $3.3 million | | **EPS (Diluted)** | $(0.36) | $0.29 | | **Adjusted EBITDA** | $(2.7) million | $6.2 million | - The decline in revenue was primarily driven by softer demand due to increased competitive pressure and, to a lesser extent, production delays[4](index=4&type=chunk) - Cash and cash equivalents stood at **$1.0 million** as of June 30, 2025, down from **$3.7 million** at the end of 2024[5](index=5&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) Sow Good's financial statements for Q2 2025 show significant declines in revenue and net income, leading to reduced assets and equity compared to the prior year [Condensed Balance Sheets](index=5&type=section&id=CONDENSED%20BALANCE%20SHEETS) As of June 30, 2025, Sow Good's total assets decreased to $50.0 million from $54.7 million, primarily due to a significant drop in cash and cash equivalents, resulting in a decline in total stockholders' equity Balance Sheet Summary (as of June 30, 2025 vs. Dec 31, 2024) | Account | June 30, 2025 (USD) | December 31, 2024 (USD) | | :--- | :--- | :--- | | **Cash and cash equivalents** | $0.96 million | $3.72 million | | **Total current assets** | $22.80 million | $25.08 million | | **Total assets** | $49.99 million | $54.70 million | | **Total current liabilities** | $5.38 million | $7.36 million | | **Total liabilities** | $21.41 million | $22.71 million | | **Total stockholders' equity** | $28.57 million | $31.99 million | [Condensed Statements of Operations](index=6&type=section&id=CONDENSED%20STATEMENTS%20OF%20OPERATIONS) For Q2 2025, Sow Good reported a significant revenue decrease to $1.9 million from $15.6 million in Q2 2024, resulting in a net loss of $4.2 million compared to a $3.3 million net income in the prior-year period Statement of Operations - Three Months Ended June 30 | Metric | 2025 (USD) | 2024 (USD) | | :--- | :--- | :--- | | **Revenues** | $1,856,312 | $15,648,046 | | **Gross Profit (Loss)** | $(129,709) | $9,007,129 | | **Net Operating Income (Loss)** | $(4,073,905) | $4,885,096 | | **Net Income (Loss)** | $(4,186,512) | $3,335,142 | | **Net Income (Loss) per Share - Diluted** | $(0.36) | $0.29 | Statement of Operations - Six Months Ended June 30 | Metric | 2025 (USD) | 2024 (USD) | | :--- | :--- | :--- | | **Revenues** | $4,333,234 | $27,054,369 | | **Gross Profit** | $973,014 | $13,636,571 | | **Net Operating Income (Loss)** | $(6,489,093) | $5,814,353 | | **Net Income (Loss)** | $(6,757,566) | $3,845,730 | | **Net Income (Loss) per Share - Diluted** | $(0.59) | $0.41 | [Statements of Changes in Stockholders' Equity](index=7&type=section&id=STATEMENTS%20OF%20CHANGES%20IN%20STOCKHOLDERS'%20EQUITY) For the six months ended June 30, 2025, total stockholders' equity decreased from $32.0 million to $28.6 million, primarily due to the net loss incurred during the period - Total stockholders' equity decreased from **$31,988,061** at the beginning of the year to **$28,570,587** at June 30, 2025[22](index=22&type=chunk) - The primary driver for the decrease in equity was the net loss of **$6,757,566** for the six-month period[22](index=22&type=chunk) [Condensed Statements of Cash Flows](index=8&type=section&id=CONDENSED%20STATEMENTS%20OF%20CASH%20FLOWS) For the six months ended June 30, 2025, Sow Good experienced a net cash outflow of $2.8 million, primarily from operating activities, resulting in a reduced cash balance Cash Flow Summary - Six Months Ended June 30 | Activity | 2025 (USD) | 2024 (USD) | | :--- | :--- | :--- | | **Net cash used in operating activities** | $(2,514,884) | $(939,534) | | **Net cash used in investing activities** | $(249,140) | $(2,228,050) | | **Net cash provided by financing activities** | $0 | $15,130,582 | | **Net change in cash** | $(2,764,024) | $11,962,998 | | **Cash at end of period** | $959,416 | $14,373,035 | [Non-GAAP Financial Measures](index=2&type=section&id=Non-GAAP%20Financial%20Measures) The company's non-GAAP Adjusted EBITDA significantly declined in Q2 2025, reflecting operational challenges, with management using this metric for performance evaluation despite its limitations [Reconciliation of Net Income (Loss) to Adjusted EBITDA](index=9&type=section&id=RECONCILIATION%20OF%20NET%20INCOME%20(LOSS)%20TO%20EBITDA%20AND%20ADJUSTED%20EBITDA) Sow Good's Adjusted EBITDA for Q2 2025 was $(2.7) million, a significant negative shift from $6.2 million in Q2 2024, reflecting operational challenges Adjusted EBITDA Reconciliation | Period | Net Income (Loss) (USD) | Adjusted EBITDA (USD) | | :--- | :--- | :--- | | **Three Months Ended June 30, 2025** | $(4,186,512) | $(2,694,394) | | **Three Months Ended June 30, 2024** | $3,335,142 | $6,216,642 | | **Six Months Ended June 30, 2025** | $(6,757,566) | $(3,485,112) | | **Six Months Ended June 30, 2024** | $3,845,730 | $8,684,628 | [Definition and Use of Non-GAAP Measures](index=2&type=section&id=Definition%20and%20Use%20of%20Non-GAAP%20Measures) Sow Good defines Adjusted EBITDA as a non-GAAP measure, used by management to assess core operating performance and business strategies, while acknowledging its inherent limitations - The company uses Adjusted EBITDA as a supplemental measure to GAAP, defining it as net income (loss) adjusted for items like depreciation, amortization, interest, taxes, and share-based compensation[9](index=9&type=chunk) - Management uses Adjusted EBITDA to evaluate business strategies, make budgeting decisions, and compare performance against peers[11](index=11&type=chunk) - The company acknowledges limitations of Adjusted EBITDA, such as the exclusion of significant recurring non-cash expenses like stock-based compensation and depreciation[14](index=14&type=chunk) [Company and Report Information](index=2&type=section&id=Company%20and%20Report%20Information) Sow Good Inc. is a U.S.-based freeze-dried snack manufacturer, and the report includes standard forward-looking statements subject to various business risks [About Sow Good Inc.](index=2&type=section&id=About%20Sow%20Good%20Inc.) Sow Good Inc. is a U.S.-based manufacturer specializing in freeze-dried candy and snacks, leveraging proprietary technology for innovation and manufacturing excellence - Sow Good is a U.S.-based manufacturer of innovative freeze-dried candy and treats, utilizing proprietary technology[8](index=8&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section contains a standard safe harbor statement advising that the press release includes forward-looking statements concerning future results, business strategy, and growth plans, which are subject to various risks and uncertainties - The report contains forward-looking statements regarding future financial position, business strategy, expected growth, and other operational plans[13](index=13&type=chunk) - These statements are subject to risks and uncertainties, including competition, supply chain issues, and the ability to retain customers, as detailed in SEC filings[13](index=13&type=chunk)[15](index=15&type=chunk)

PART I—FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company reported a net loss of $7.4 million for Q2 2025 and $8.2 million year-to-date, facing a $8.5 million stockholders' deficit and a going concern warning [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet highlights a decrease in cash and total assets, alongside a stockholders' deficit of $8.5 million as of June 30, 2025 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $7,285 | $12,155 | | Total current assets | $11,985 | $16,157 | | **TOTAL ASSETS** | **$22,125** | **$27,337** | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $7,574 | $10,291 | | **TOTAL LIABILITIES** | **$30,675** | **$36,194** | | **TOTAL STOCKHOLDERS' DEFICIT** | **($8,550)** | **($8,857)** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $7.4 million for Q2 2025 and $8.2 million for the six months ended June 30, 2025, with reduced operating losses year-over-year Statement of Operations Highlights (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $27 | $91 | $108 | $164 | | Research and development | $3,514 | $4,150 | $4,995 | $10,019 | | General and administrative | $2,377 | $3,314 | $5,033 | $6,734 | | Loss from operations | ($5,864) | ($7,391) | ($9,940) | ($16,623) | | **Net loss** | **($7,419)** | **($6,785)** | **($8,170)** | **($17,865)** | | **Net loss per share** | **($0.78)** | **($1.06)** | **($0.89)** | **($2.78)** | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Operating activities used $9.7 million in cash for the first six months of 2025, partially offset by financing activities, leading to a net decrease in cash Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Cash Flow Category | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($9,755) | ($13,438) | | Net cash provided by investing activities | $0 | $6,319 | | Net cash provided by financing activities | $4,806 | $9 | | **Net decrease in cash** | **($4,870)** | **($7,139)** | | **Cash at end of period** | **$7,343** | **$21,740** | - Financing activities in the first six months of 2025 were primarily driven by **$5.0 million** in net proceeds from the issuance of common stock[13](index=13&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's focus on nanotechnology therapeutics, a reverse stock split, and subsequent financing activities post-quarter end - The company is a clinical-stage pharmaceutical firm focused on clean-surfaced nanotechnology therapeutics for neurological disorders like ALS, MS, and Parkinson's disease[15](index=15&type=chunk) - A **1-for-20 reverse stock split** was effective July 11, 2024, with all historical share and per-share data retroactively adjusted[24](index=24&type=chunk)[25](index=25&type=chunk) - Subsequent to quarter-end, the company sold an additional **$1.9 million** of common stock via its ATM agreement, amended its 2024 SSCP Notes to extend maturity, and issued **$1.5 million** in new 2025 SSCP Notes[133](index=133&type=chunk)[134](index=134&type=chunk)[135](index=135&type=chunk) - The company has raised **$1.5 million** from the issuance of new senior secured convertible promissory notes (2025 SSCP Notes) on August 13, 2025[135](index=135&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Operating loss decreased to $9.9 million year-to-date 2025 due to reduced expenses, with FDA guidance for CNM-Au8® in ALS, but going concern doubts remain [Business Overview and Recent Developments](index=32&type=section&id=Business%20Overview%20and%20Recent%20Developments) The company focuses on clean-surfaced nanotechnology for neurodegenerative diseases and received FDA guidance for an accelerated approval pathway for CNM-Au8® in ALS - The company is focused on developing clean-surfaced nanotechnology (CSN®) therapeutics for neurodegenerative diseases, with lead programs in ALS, MS, and Parkinson's disease[138](index=138&type=chunk)[140](index=140&type=chunk) - Following a meeting with the FDA's Division of Neurology 1 (DN1), the company received guidance on a potential **accelerated approval pathway** for its lead drug candidate, CNM-Au8®, in ALS[145](index=145&type=chunk) - The company plans to submit a New Drug Application (NDA) for CNM-Au8® by the end of 2025, contingent on supportive data from its ongoing Expanded Access Programs (EAPs), with a confirmatory Phase 3 trial planned for the first half of 2026, subject to funding[146](index=146&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) Operating loss decreased by 40% year-to-date 2025, driven by significant reductions in research and development and general and administrative expenses Comparison of Results of Operations (in thousands) | Metric | Q2 2025 | Q2 2024 | Change | YTD 2025 | YTD 2024 | Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Total revenue | $27 | $91 | (70)% | $108 | $164 | (34)% | | Research and development | $3,514 | $4,150 | (15)% | $4,995 | $10,019 | (50)% | | General and administrative | $2,377 | $3,314 | (28)% | $5,033 | $6,734 | (25)% | | **Loss from operations** | **($5,864)** | **($7,391)** | **(21)%** | **($9,940)** | **($16,623)** | **(40)%** | | **Net loss** | **($7,419)** | **($6,785)** | **9%** | **($8,170)** | **($17,865)** | **(54)%** | - The **50% decrease in YTD R&D expense** was driven by lower manufacturing and research costs, reduced personnel expenses, and a significant increase in grant revenue recognition (**$6.2 million in 2025 vs $2.0 million in 2024**), partially offset by increased clinical program costs for ALS[165](index=165&type=chunk)[166](index=166&type=chunk) - The **25% decrease in YTD G&A expense** was primarily due to cost-saving initiatives leading to lower personnel, stock-based compensation, legal, and public relations costs[167](index=167&type=chunk) [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces substantial doubt about its going concern ability due to recurring losses, necessitating additional capital raises and cost-saving measures - The company has incurred significant losses since inception and expects future losses, leading management to conclude there is **substantial doubt about its ability to continue as a going concern** beyond one year from the financial statement issuance date[172](index=172&type=chunk)[177](index=177&type=chunk)[178](index=178&type=chunk) - To mitigate funding needs, the company plans to raise additional capital through equity/debt financing, licensing, and utilizing its at-the-market (ATM) facility, while also implementing cost-saving measures like reducing R&D programs, cutting employee compensation, and eliminating staff positions[178](index=178&type=chunk) Sources of Capital Since Inception (Gross Proceeds) | Source | Amount | | :--- | :--- | | Equity Financing | $192.1 million | | Borrowings (Debt) | $69.6 million | | Grants | $11.6 million | | R&D Tax Credits | $10.1 million | | Reverse Recapitalization | $9.4 million | | Option/Warrant Exercises | $1.1 million | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=46&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is not required to provide the information for this item - As a smaller reporting company, Clene Inc. is not required to provide quantitative and qualitative disclosures about market risk[203](index=203&type=chunk) [Item 4. Controls and Procedures](index=46&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were ineffective as of June 30, 2025, due to material weaknesses in internal control over financial reporting, with remediation ongoing - Management's evaluation concluded that disclosure controls and procedures were **not effective** as of June 30, 2025[204](index=204&type=chunk) - The ineffectiveness is due to material weaknesses in internal control over financial reporting identified in the 2024 audit, relating to the control environment, review processes, and IT general controls[206](index=206&type=chunk)[209](index=209&type=chunk) - Remediation efforts are ongoing in 2025, including strengthening the internal accounting team, refining processes, and engaging external consultants for complex accounting matters[207](index=207&type=chunk) PART II—OTHER INFORMATION [Item 1. Legal Proceedings](index=48&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material pending legal proceedings - As of the report date, the company is not involved in any material legal proceedings[211](index=211&type=chunk) [Item 1A. Risk Factors](index=48&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors disclosed in the company's 2024 Annual Report on Form 10-K, except for a risk factor that was disclosed in the Q1 2025 Form 10-Q - No material changes to risk factors have occurred since the 2024 Annual Report on Form 10-K, other than one previously disclosed in the Q1 2025 10-Q[212](index=212&type=chunk) [Other Items (Items 2, 3, 4, 5, 6)](index=48&type=section&id=Other%20Items) The company reports no unregistered sales of equity securities, no defaults upon senior securities, and no other material information required to be disclosed under Item 5 during the quarter - There were no unregistered sales of equity securities, defaults on senior securities, or other material information to report for the quarter[213](index=213&type=chunk)[215](index=215&type=chunk)[217](index=217&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________ FORM 10-Q x 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 o 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 001-41104 VOLATO GROUP, INC. (Exact name of Registrant as specified in its charter) (State or ot ...