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 ...

[PART I FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company's financial statements reflect a significant operational transformation, shifting from a net loss to net income driven by a strategic focus on aircraft sales [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) Total assets and liabilities decreased substantially due to the discontinuation of aircraft fleet operations, while the shareholders' deficit narrowed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $4,707 | $2,161 | | Total current assets | $10,686 | $43,314 | | Total assets | $13,048 | $46,299 | | **Liabilities & Shareholders' Deficit** | | | | Total current liabilities | $20,005 | $62,200 | | Total liabilities | $20,112 | $62,633 | | Total shareholders' deficit | $(7,064) | $(16,334) | | Total liabilities and shareholders' deficit | $13,048 | $46,299 | [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) The company achieved a significant turnaround, with revenue from continuing operations soaring to $50.3 million, resulting in a total net income of $4.1 million Statement of Operations Summary (in thousands, except per share data) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenue | $50,338 | $229 | | Operating income (loss) | $3,398 | $(7,985) | | Net income (loss) from continuing operations | $3,043 | $(13,192) | | Net income (loss) | $4,057 | $(34,308) | | Net income (loss) per share, basic | $1.82 | $(29.34) | | Net income (loss) per share, diluted | $1.08 | $(29.34) | Quarterly Performance (Q2 2025 vs Q2 2024, in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenue | $24,855 | $181 | | Operating income (loss) | $872 | $(3,651) | | Net income (loss) | $3,602 | $(16,918) | [Consolidated Statements of Changes In Shareholders' Deficit](index=7&type=section&id=Consolidated%20Statements%20of%20Changes%20In%20Shareholders'%20Deficit) The shareholders' deficit improved to $(7.1) million from $(16.3) million, driven by net income and an increase in paid-in capital from stock issuances - The total shareholders' deficit decreased from **$16.3 million** at December 31, 2024, to **$7.1 million** at June 30, 2025[18](index=18&type=chunk) - Key drivers for the improvement in shareholders' deficit during the first six months of 2025 were **net income of $4.1 million** and the issuance of 2,778,885 shares of common stock, which increased additional paid-in capital[18](index=18&type=chunk) [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) The company generated positive operating cash flow of $0.5 million, a significant improvement from the prior year, increasing total cash to $4.7 million Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $536 | $(7,367) | | Net cash provided by (used in) investing activities | $30 | $(113) | | Net cash provided by (used in) financing activities | $141 | $(1,994) | | **Net increase (decrease) in cash** | **$707** | **$(9,474)** | | **Cash and restricted cash, end of period** | **$4,707** | **$7,249** | [Notes to Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail a strategic transition to flyExclusive, a subsidiary sale, a reverse stock split, and a planned merger, while acknowledging going concern doubts - The company transitioned its aircraft ownership fleet operations to flyExclusive in September 2024 to focus on high-growth areas like **aircraft sales and proprietary software**[25](index=25&type=chunk) - On March 20, 2025, the company sold its subsidiary GC Aviation, Inc, which held the FAA Part 135 certificate, for **$2.0 million**[26](index=26&type=chunk) - The company has a **working capital deficit of $9.3 million** and an **accumulated deficit of $100.3 million** as of June 30, 2025, which raises substantial doubt about its ability to continue as a going concern[27](index=27&type=chunk) - Subsequent to the quarter end, on July 29, 2025, the company entered into a **merger agreement with M2i Global**, where M2i would become a wholly-owned subsidiary of Volato[158](index=158&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=35&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the dramatic financial improvement to its strategic shift towards aircraft sales and software, highlighted by the sale of two Gulfstream G280 aircraft - The company's business model has shifted to focus on **aircraft sales and proprietary software** (like the Vaunt platform) after transitioning its fleet operations to flyExclusive in September 2024[161](index=161&type=chunk) - The company delivered and sold its second and third Gulfstream G280 aircraft in February and June 2025, respectively, which was the **primary driver of revenue growth**[164](index=164&type=chunk) - On July 29, 2025, the company entered into a **merger agreement with M2i Global**, a company specializing in the global value supply chain for critical minerals; post-merger, M2i stockholders are expected to own approximately **85% of the combined company**[163](index=163&type=chunk) Financial Highlights for Six Months Ended June 30, 2025 | Metric | H1 2025 | Change vs H1 2024 | | :--- | :--- | :--- | | Total Revenue | $50.3 million | +$50.1 million | | Net Income from Continuing Operations | $3.0 million | +$16.2 million | | Total Net Income | $4.1 million | +$38.4 million | [Quantitative and Qualitative Disclosures about Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a "smaller reporting company," the company is not required to provide market risk disclosures - As a smaller reporting company, Volato Group, Inc is **exempt from providing quantitative and qualitative disclosures about market risk**[207](index=207&type=chunk) [Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal controls during the quarter - Based on an evaluation as of the end of the reporting period, the CEO and CFO concluded that the company's **disclosure controls and procedures were effective**[210](index=210&type=chunk) - **No changes occurred** during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[211](index=211&type=chunk) [PART II OTHER INFORMATION](index=44&type=section&id=PART%20II%20OTHER%20INFORMATION) [Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) The company is defending a lawsuit from former employees alleging WARN Act violations but does not expect a material adverse effect from current litigation - The company is a defendant in a lawsuit filed by former employees alleging **violations of the WARN Act** following the termination of 230 employees; the plaintiffs are seeking unpaid wages and benefits[150](index=150&type=chunk) - Management does not currently believe that its outstanding litigation will have a **material adverse effect** on its financial statements, but acknowledges the uncertainty of litigation[149](index=149&type=chunk) [Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) The company highlights new risks associated with its planned merger with M2i Global, including potential completion failure and business disruption - The company has entered into a **merger agreement with M2i Global, Inc**, which introduces new and additional risk factors[215](index=215&type=chunk) - Specific risks related to the merger include the potential for the merger not to be completed, failure to satisfy closing conditions, the effect of the announcement on business relationships, and risks related to diverting management's attention[215](index=215&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=46&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the quarter, the company issued over 2.5 million shares to convert a $4.5 million note and issued a new $1.5 million convertible note - In June 2025, the company issued **2,538,939 shares of common stock** upon the full conversion of a **$4.5 million convertible note**[217](index=217&type=chunk) - On June 13, 2025, the company issued a new convertible promissory note in the principal amount of **$1.5 million**[217](index=217&type=chunk) [Defaults Upon Senior Securities](index=46&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - None[220](index=220&type=chunk) [Mine Safety Disclosures](index=46&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[222](index=222&type=chunk) [Other Information](index=47&type=section&id=Item%205.%20Other%20Information) No information required to be disclosed on a Form 8-K was omitted during the quarter - No material information was omitted from required Form 8-K filings during the quarter[225](index=225&type=chunk) [Exhibits](index=47&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents and officer certifications

FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ 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: 001-38418 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 COCRYSTAL PHARMA, INC. (Exact name of registrant as specified in its charter) | Delaware | 35-2528215 | | --- | --- | | (State or Oth ...

Exhibit 99.1 Synergy CHC Corp Reports Second Quarter 2025 Financial Results and its Tenth Consecutive Quarter of Profitability WESTBROOK, Maine, August 14, 2025 – Synergy CHC Corp. (NASDAQ: SNYR) ("Synergy" or the "Company"), a consumer health and wellness company, is announcing its financial results for the three months ended June 30, 2025. "We are pleased to report another strong quarter, marking our tenth consecutive quarter of profitability," said Jack Ross, CEO of Synergy. "Revenue, gross profit, net i ...

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

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