FibroBiologics(FBLG) - 2025 Q2 - Quarterly Report

FORM 10-Q Cover Page This section provides key administrative and financial details of the registrant, FibroBiologics, Inc., including its status and shares outstanding - Registrant: FibroBiologics, Inc., a Delaware corporation headquartered in Houston, TX [2] - Filer Status: Non-accelerated filer, Smaller reporting company, and Emerging growth company [4] - Shares Outstanding: 41,889,142 shares of Common Stock as of July 30, 2025 [4] Securities Registered | Title of each class | Trading symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Stock, $0.00001 par value | FBLG | The Nasdaq Capital Market | SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This section outlines the nature of forward-looking statements, their reliance on current expectations, and inherent risks and uncertainties - Forward-looking statements are covered by safe harbor provisions and encompass future operations, financial position, product approvals, R&D costs, revenue, clinical trials, and market opportunities [9] - Statements are based on current expectations and projections, subject to risks and uncertainties detailed in 'Risk Factors' sections [11] - Key areas of forward-looking statements include the timing and results of preclinical/clinical trials, regulatory approvals, commercialization strategy, competitive position, intellectual property, and funding needs [12] PART I — FINANCIAL INFORMATION This part presents the company's unaudited financial statements, management's discussion and analysis, and disclosures on market risk and controls - The financial statements are unaudited and prepared in accordance with GAAP for interim financial information, and should be read in conjunction with the Annual Report on Form 10-K for December 31, 2024 [34] - The company operates as a single reportable segment, focusing on the discovery, development, and commercialization of fibroblast-based cell therapies [31] - Significant estimates in financial reporting include liability classified instruments, warrant liability, forward contract liability, SEPA put option liability, fair value of short-term convertible debt, and stock-based compensation [37] - The company has incurred operating losses since inception and expects them to continue, with an accumulated deficit of $45.1 million and cash and cash equivalents of $8.8 million as of June 30, 2025 [30][115][160] - Substantial doubt exists about the company's ability to continue as a going concern, dependent on raising additional capital through equity, debt, or collaborations [30][167][185] - Research and development expenses increased significantly, driven by higher CRO costs, personnel expenses, and research materials, reflecting advancement in product candidate development [132][147] Item 1. Financial Statements (Unaudited) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, equity changes, cash flows, and detailed notes Condensed Consolidated Balance Sheets This statement presents the company's financial position, detailing assets, liabilities, and stockholders' equity at specific points in time Condensed Consolidated Balance Sheets | Item | June 30, 2025 (unaudited, in thousands of dollars) | December 31, 2024 (in thousands of dollars) | Change (in thousands of dollars) | | :-------------------------------- | :------------------------ | :---------------- | :----- | | Cash and cash equivalents | $8,845 | $13,985 | $(5,140) | | Total current assets | $10,178 | $14,228 | $(4,050) | | Total assets | $13,907 | $16,445 | $(2,538) | | Total current liabilities | $10,964 | $12,726 | $(1,762) | | Total liabilities | $13,047 | $13,710 | $(663) | | Total stockholders' equity | $860 | $2,735 | $(1,875) | | Accumulated deficit | $(45,142) | $(35,518) | $(9,624) | Unaudited Condensed Consolidated Statements of Operations This statement details the company's revenues, expenses, and net income or loss over specific interim periods - Net loss for the three months ended June 30, 2025, was $(4.7) million, a significant decrease from a net income of $0.9 million in the prior year, largely due to the absence of a $5.5 million gain from warrant liability fair value change in 2024 [19][131] - Net loss for the six months ended June 30, 2025, increased to $(9.6) million from $(7.6) million in 2024, primarily due to higher operating expenses and changes in fair value of financial instruments [19][145] Condensed Consolidated Statements of Operations | Item | Three Months Ended June 30, 2025 (in thousands of dollars) | Three Months Ended June 30, 2024 (in thousands of dollars) | Six Months Ended June 30, 2025 (in thousands of dollars) | Six Months Ended June 30, 2024 (in thousands of dollars) | | :-------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Research and development | $2,041 | $975 | $3,821 | $1,935 | | General, administrative and other | $2,449 | $2,249 | $5,200 | $4,739 | | Total operating expenses | $4,490 | $3,224 | $9,021 | $6,674 | | Loss from operations | $(4,490) | $(3,224) | $(9,021) | $(6,674) | | Net income/(loss) | $(4,658) | $898 | $(9,624) | $(7,562) | | Net income/(loss) per share, basic and diluted | $(0.12) | $0.03 | $(0.26) | $(0.24) | Unaudited Condensed Consolidated Statements of Changes in Stockholders' Equity/(Deficit) This statement tracks changes in the company's equity, including net income/loss, stock issuances, and other comprehensive income - During the six months ended June 30, 2025, the company issued 5,657,747 shares of Common Stock from the conversion of $5.8 million of short-term convertible notes, contributing to additional paid-in capital [67] Changes in Stockholders' Equity | Item | Balance – December 31, 2024 (in thousands of dollars) | Net Loss (Q1 2025, in thousands of dollars) | Net Loss (Q2 2025, in thousands of dollars) | Balance – June 30, 2025 (in thousands of dollars) | | :-------------------------------- | :-------------------------- | :----------------- | :----------------- | :------------------------ | | Additional paid-in capital | $38,253 | $4,581 | $3,168 | $46,002 | | Accumulated deficit | $(35,518) | $(4,966) | $(4,658) | $(45,142) | | Total Stockholders' Equity | $2,735 | $(4,966) | $(4,658) | $860 | Unaudited Condensed Consolidated Statements of Cash Flows This statement summarizes cash inflows and outflows from operating, investing, and financing activities over specific interim periods - Operating cash outflow increased by $3.0 million year-over-year, mainly due to higher net losses and changes in working capital [25][163] - Financing activities provided $4.4 million in cash for the six months ended June 30, 2025, primarily from proceeds of short-term convertible debt [25][165] Condensed Consolidated Statements of Cash Flows | Cash Flow Activity | Six Months Ended June 30, 2025 (in thousands of dollars) | Six Months Ended June 30, 2024 (in thousands of dollars) | | :-------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(9,259) | $(6,222) | | Net cash used in investing activities | $(256) | $(74) | | Net cash provided by financing activities | $4,375 | $3,106 | | Net increase/(decrease) in cash and cash equivalents | $(5,140) | $(3,190) | | Cash and cash equivalents, end of period | $8,845 | $5,973 | Notes to the Unaudited Condensed Consolidated Financial Statements These notes offer detailed explanations of the company's organization, accounting policies, financial instrument valuations, equity changes, and commitments Note 1. Organization, Description of Business, and Liquidity This note describes the company's business, its Nasdaq listing, and highlights liquidity concerns and going concern risks - FibroBiologics is an early-stage cell therapy company focused on developing treatments for chronic diseases using fibroblast cells, including wound healing, multiple sclerosis, degenerative disc disease, psoriasis, and human longevity applications [27] - The company completed a direct listing on Nasdaq on January 31, 2024, converting all non-voting stock and certain preferred stock into voting common stock [28] - As of June 30, 2025, the company had an accumulated deficit of $45.1 million and $8.8 million in cash, raising substantial doubt about its ability to continue as a going concern without additional capital [30] Note 2. Summary of Significant Accounting Policies This note outlines the key accounting principles and methods used in preparing the condensed consolidated financial statements - Financial statements are prepared in accordance with GAAP for interim information and SEC regulations, with interim results not necessarily indicative of full-year performance [34][35] - The company has elected the fair value option for its short-term convertible debt, with unrealized gains and losses reported in the statements of operations [38] - Research and development costs are expensed as incurred, including salaries, benefits, facilities, supplies, manufacturing, preclinical expenses, and contracted services [52][54] Note 3. Net Income/(Loss) per Share Attributable to Common Stockholders This note details the calculation of basic and diluted net income or loss per share for common stockholders - Basic and diluted net income/(loss) per share are the same for all periods presented because the company reported net losses, making the inclusion of potential common shares anti-dilutive [67] Net Income/(Loss) per Share | Item | Three Months Ended June 30, 2025 (in thousands of dollars) | Three Months Ended June 30, 2024 (in thousands of dollars) | Six Months Ended June 30, 2025 (in thousands of dollars) | Six Months Ended June 30, 2024 (in thousands of dollars) | | :-------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Net income/(loss) | $(4,658) | $898 | $(9,624) | $(7,562) | | Weighted-average shares outstanding, basic and diluted (shares) | 38,635,264 | 32,719,125 | 37,665,612 | 31,926,444 | | Net income/(loss) per common share, basic and diluted | $(0.12) | $0.03 | $(0.26) | $(0.24) | Note 4. Property and Equipment This note provides details on the company's property and equipment, including additions, disposals, and depreciation - Depreciation expense for the six months ended June 30, 2025, was $113,000, an increase from $72,000 in the prior year [70] Property and Equipment, Net | Item | June 30, 2025 (in thousands of dollars) | December 31, 2024 (in thousands of dollars) | | :-------------------------------- | :-------------- | :---------------- | | Laboratory equipment | $1,195 | $981 | | Computer equipment, software, and other | $89 | $47 | | Total property and equipment at cost | $1,284 | $1,028 | | Less: Accumulated depreciation | $(317) | $(204) | | Property and equipment, net | $967 | $824 | Note 5. Fair Value of Financial Instruments This note details the fair value measurements of financial instruments, categorized by valuation input levels - Short-term convertible debt and SEPA put option liability are classified as Level 3, with their fair values determined using Monte Carlo simulation valuation models [71][72][73] - The fair value of short-term convertible debt decreased from $9.2 million at December 31, 2024, to $8.1 million at June 30, 2025, while the SEPA put option liability remained stable at $0.5 million [71] Fair Value Measurement as of June 30, 2025 | Item | Level 1 (in thousands of dollars) | Level 2 (in thousands of dollars) | Level 3 (in thousands of dollars) | Total (in thousands of dollars) | | :-------------------------- | :------ | :------ | :------ | :------ | | Cash equivalents | $8,521 | $— | $— | $8,521 | | SEPA put option liability | $— | $— | $470 | $470 | | Short-term convertible debt | $— | $— | $8,066 | $8,066 | Note 6. Stockholders' Equity/(Deficit) This note outlines the authorized and outstanding shares, as well as significant changes in the company's equity structure - As of June 30, 2025, the company authorized 300,000,000 shares of Common Stock and 10,000,000 shares of preferred stock (2,500 Series C) [75] - The Direct Listing on January 31, 2024, resulted in the conversion of all outstanding non-voting Common Stock, Series B, and Series B-1 Preferred Stock into voting Common Stock, and the cancellation of Series A Preferred Stock [77] - In June 2025, the authorized Common Stock was increased from 100,000,000 to 300,000,000 shares [79] Note 7. Standby Equity Purchase Agreement This note details the terms of the Standby Equity Purchase Agreement, including convertible notes and their conversion activity - The company entered into a SEPA on December 20, 2024, to issue $15.0 million in short-term convertible notes across three tranches, with the final $5.0 million tranche received on June 16, 2025 [80][81] - The convertible notes accrue 0% interest, increasing to 18% upon default, and mature on December 20, 2025, with potential extensions [80] Summary of Convertible Debt Conversions | Date | Tranche | Principal Amount (dollars) | Shares Issued (shares) | Price Per Share (dollars) | | :--------------- | :---------- | :--------------- | :------------ | :-------------- | | January 23, 2025 | Second Note | $900,000 | 552,113 | $1.6301 | | January 27, 2025 | Second Note | $500,000 | 317,238 | $1.5761 | | January 29, 2025 | Second Note | $500,000 | 334,336 | $1.4955 | | February 7, 2025 | Second Note | $1,100,000 | 732,941 | $1.5008 | | February 21, 2025 | Second Note | $250,000 | 232,169 | $1.0768 | | March 4, 2025 | Second Note | $350,000 | 361,794 | $0.9674 | | April 11, 2025 | Second Note | $200,000 | 263,643 | $0.7586 | | April 15, 2025 | Second Note | $200,000 | 263,643 | $0.7586 | | May 15, 2025 | Second Note | $300,000 | 388,450 | $0.7723 | | June 2, 2025 | Second Note | $100,000 | 147,579 | $0.6776 | | June 3, 2025 | Second Note | $300,000 | 442,739 | $0.6776 | | June 20, 2025 | Second Note | $100,000 | 144,216 | $0.6934 | | June 24, 2025 | Second Note | $200,000 | 295,377 | $0.6771 | | June 26, 2026 | Third Note | $300,000 | 443,066 | $0.6771 | | June 27, 2025 | Third Note | $500,000 | 738,443 | $0.6771 | Note 8. Income Taxes This note explains the company's income tax position, including its effective tax rate and valuation allowance - The effective income tax rate was 0.0% for all periods presented [89] - A full valuation allowance has been recorded against net deferred tax assets, as it is more likely than not that the company will not recognize these benefits [89] Note 9. Leases, Commitments and Contingencies This note details the company's operating lease obligations, rent expenses, and other material commitments - The company entered a new operating lease in March 2025 for 10,693 square feet of R&D space in Houston, with a term ending May 31, 2031, and initial monthly rent of $32,000 [92] - Rent expense for the six months ended June 30, 2025, was $0.4 million, an increase from $0.3 million in the prior year [95] Maturities of Operating Lease Liability as of June 30, 2025 | Year | Amount (in thousands of dollars) | | :--- | :----- | | 2026 | $790 | | 2027 | $886 | | 2028 | $576 | | 2029 | $351 | | 2030 | $359 | | Thereafter | $153 | | Total lease payments | $3,115 | | Less: Imputed interest | $(405) | | Total lease liability | $2,710 | | Less: Current lease liability | $(627) | | Total non-current lease liability | $2,083 | Note 10. Stock-Based Compensation This note details the company's stock-based compensation expense and unrecognized costs related to equity awards - As of June 30, 2025, unrecognized stock-based compensation costs totaled $6.3 million, expected to be recognized over a weighted-average period of 2.6 years [98] - The weighted-average grant date fair value of options granted during the six months ended June 30, 2025, was $0.87 per share, significantly lower than $10.63 per share in the prior year [99] Stock-Based Compensation Expense | Expense Category | Three Months Ended June 30, 2025 (in thousands of dollars) | Three Months Ended June 30, 2024 (in thousands of dollars) | Six Months Ended June 30, 2025 (in thousands of dollars) | Six Months Ended June 30, 2024 (in thousands of dollars) | | :-------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Research and development | $116 | $92 | $200 | $165 | | General and administrative | $613 | $487 | $1,080 | $893 | | Total stock-based compensation expense | $729 | $579 | $1,280 | $1,058 | Note 11. Related Party Transactions This note discloses transactions with related parties, including payments for strategic advisory services - The company paid $62,400 to a Board of Directors member for strategic advisory services, including finance and capital raising support, during the three months ended June 30, 2025 [100] Note 12. Subsequent Events This note reports significant events occurring after the balance sheet date, such as stock conversions and legislative impacts - In July 2025, the investor converted an additional $600,000 in principal amount of notes into 1,026,686 shares of Common Stock [101] - The One Big Beautiful Bill Act (OBBBA), enacted on July 4, 2025, is not expected to have a material impact on the company's estimated annual effective tax or deferred taxes [102] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section discusses the company's financial condition, results of operations, and future outlook, focusing on its clinical-stage biotechnology, ongoing losses, and funding needs - The company is a clinical-stage biotechnology firm developing fibroblast-based therapies for chronic diseases, with lead candidates CYWC628, CYMS101, and CybroCell™ [105] - FibroBiologics has incurred significant net losses since inception ($9.6 million for six months ended June 30, 2025) and expects these losses to continue and increase as product candidates advance through clinical development [115] - The company requires substantial additional funding to support long-term operations and growth, with financing expected through equity sales, debt, or strategic collaborations [116] Overview This overview highlights the company's focus on preclinical and clinical development of fibroblast treatments for various chronic diseases - The company's primary focus is on preclinical studies and clinical trials for fibroblast treatments for wound healing (CYWC628), multiple sclerosis (CYMS101), degenerative disc disease (CybroCell™), psoriasis (CYPS317), and early-stage research for human longevity and certain cancers [105][106][107][108][109][110] - CYWC628 is in late pre-clinical stages for wound healing, with plans to initiate a Phase 1/2 clinical trial in Australia in Q1 2026 [106][117] - CybroCell™ has received IND clearance from the FDA for a 'first in human' trial for degenerative disc disease, conditional on master cell bank approval [108] General Trends and Outlook This section discusses key developments and future expectations, including updates on clinical trial timelines and manufacturing progress - The Phase 1/2 clinical trial for CYWC628 in diabetic foot ulcers in Australia is now expected to initiate in Q1 2026 and complete in Q3 2026, extended due to manufacturing training run process issues and sterility testing [117] - Experiments confirm the ability to use the CYWC628 master cell bank for CybroCell™ manufacturing, and the company is working to amend the IND clearance for CybroCell™'s planned Phase I clinical trial [118] Components of Results of Operations This section breaks down the key components influencing the company's financial performance, including revenue and various expense categories Revenue The company has not generated product revenue and anticipates no such revenue in the foreseeable future - The company has not generated any revenue from product sales and does not expect to in the foreseeable future [119] - Future revenue generation is contingent on successful development, regulatory approval, and commercialization of product candidates, which is highly uncertain [119] Research and Development Expenses This section details R&D costs, which are expensed as incurred and are expected to increase significantly with clinical advancements - R&D expenses are expensed as incurred and include employee-related costs, lab equipment, third-party CROs/CDMOs, consultants, preclinical/clinical trial costs, and technology expenses [121][125] - R&D expenses are expected to increase substantially due to advancing product candidates into later clinical stages and new candidates into clinical development [122] - The duration and completion costs of R&D projects are uncertain due to risks associated with product development, regulatory approvals, manufacturing, and market acceptance [122][126] General, Administrative and Other Expenses This section covers G&A expenses, including personnel and professional services, which are expected to rise with public company operations - G&A expenses include personnel costs (salaries, benefits, stock-based compensation), allocated facilities costs, and professional services (legal, accounting, marketing, investor relations) [124] - These expenses are expected to increase due to operating as a public company, compliance with SEC/Nasdaq rules, insurance, investor relations, and expanding administrative functions [124][128] Interest Expense This section outlines interest expense, primarily from short-term borrowings and amortization of convertible note discounts - Interest expense mainly comprises interest on short-term borrowing for D&O insurance premiums and amortization of discount on convertible notes [129] Results of Operations This section analyzes the company's financial performance over specific periods, detailing changes in expenses and net loss Comparison of Three Months Ended June 30, 2025 and 2024 This comparison highlights the significant increase in net loss, primarily due to higher R&D expenses and the absence of a prior-year gain - Research and development expenses increased by $1.1 million, primarily due to $0.9 million in increased CRO costs for clinical trial preparation and $0.2 million in personnel expenses [132][135] - The absence of a $5.5 million gain from the change in fair value of warrant liability in 2025, present in 2024, was a major factor in the shift from net income to net loss [131][133] Results of Operations (Three Months Ended June 30) | Item | 2025 (in thousands of dollars) | 2024 (in thousands of dollars) | Change (in thousands of dollars) | | :-------------------------------- | :----- | :----- | :----- | | Research and development | $2,041 | $975 | $1,066 | | General, administrative and other | $2,449 | $2,249 | $200 | | Total operating expenses | $4,490 | $3,224 | $1,266 | | Loss from operations | $(4,490) | $(3,224) | $(1,266) | | Change in fair value of warrant liability | $— | $5,527 | $(5,527) | | Net loss | $(4,658) | $898 | $(5,556) | Comparison of Six Months Ended June 30, 2025 and 2024 This comparison shows an increased net loss, driven by higher R&D and general and administrative expenses - R&D expenses increased by $1.9 million, driven by higher chemistry, manufacturing and control costs ($0.2 million), CRO costs ($0.9 million), personnel expenses ($0.3 million), and research materials ($0.5 million) [147][155] - General, administrative and other expenses increased by $0.5 million, mainly due to added personnel ($0.5 million) and increased professional fees ($0.3 million), partially offset by decreased Direct Listing expenses [148][155] Results of Operations (Six Months Ended June 30) | Item | 2025 (in thousands of dollars) | 2024 (in thousands of dollars) | Change (in thousands of dollars) | | :-------------------------------- | :----- | :----- | :----- | | Research and development | $3,821 | $1,935 | $1,886 | | General, administrative and other | $5,200 | $4,739 | $461 | | Total operating expenses | $9,021 | $6,674 | $2,347 | | Loss from operations | $(9,021) | $(6,674) | $(2,347) | | Net loss | $(9,624) | $(7,562) | $(2,062) | Liquidity and Capital Resources This section assesses the company's ability to meet its financial obligations, detailing cash position, funding sources, and future capital needs Overview This overview summarizes the company's cash position, accumulated deficit, and historical funding sources - As of June 30, 2025, the company had $8.8 million in cash and cash equivalents and an accumulated deficit of $45.1 million [160] - Funding sources include $15.0 million from convertible notes, $18.6 million from preferred stock sales, $10.4 million from common stock sales (GEM SPA), and $13.1 million from additional convertible notes (SEPA) [160] Cash Flows This section analyzes cash flows from operating, investing, and financing activities over specific periods - Net cash used in operating activities increased to $9.3 million in 2025 from $6.2 million in 2024, driven by higher net losses [163] - Net cash provided by financing activities increased to $4.4 million in 2025 from $3.1 million in 2024, mainly from proceeds of short-term convertible debt [165] Summary of Cash Flows (Six Months Ended June 30) | Activity | 2025 (in thousands of dollars) | 2024 (in thousands of dollars) | | :-------------------------------- | :----- | :----- | | Net cash used in operating activities | $(9,259) | $(6,222) | | Net cash used in investing activities | $(256) | $(74) | | Net cash provided by financing activities | $4,375 | $3,106 | | Net decrease in cash and cash equivalents | $(5,140) | $(3,190) | Funding Requirements This section outlines the company's ongoing need for substantial capital to support operations, R&D, and address going concern risks - The company expects continued operating losses and significant costs for infrastructure, intellectual property development, R&D, and public company operations [167] - Substantial doubt exists about the company's ability to continue as a going concern, requiring additional capital through equity financings, debt, or collaborations [167][168] - Future funding needs depend on clinical trial progress, manufacturing costs, regulatory approvals, intellectual property protection, and commercialization efforts [169][172] Contractual Obligations and Commitments This section summarizes the company's material cash requirements and contractual obligations, primarily related to lease agreements - Material cash requirements and contractual obligations are primarily related to office and lab rent, as described in Note 9 [170] Critical Accounting Estimates This section discusses accounting estimates that involve significant judgment and assumptions, which can materially impact financial results - Critical accounting estimates involve subjective judgments and assumptions about uncertain matters that materially impact financial condition and results of operations [174] - Estimates are based on historical experience and reasonable factors, but actual results may differ under different assumptions [173] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, FibroBiologics is not required to provide quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk [175] Item 4. Controls and Procedures Management concluded disclosure controls were ineffective due to a material weakness in segregation of duties; remediation plans are in progress - Management identified a material weakness in internal control over financial reporting due to ineffective design and implementation of controls over proper segregation of duties, leading to the conclusion that disclosure controls and procedures were not effective as of June 30, 2025 [177][178] - The material weakness stems from a limited number of individuals handling all financial functions [178] - Remediation plans include strengthening internal controls, adding staff, evaluating segregation of duties, and implementing initiatives to improve financial reporting controls as the company grows [179] PART II — OTHER INFORMATION This part covers legal proceedings, updated risk factors, equity sales, and other miscellaneous disclosures - The company is not currently party to any material legal proceedings [183] - Key risk factors include substantial doubt about the company's ability to continue as a going concern, complexities and potential delays in manufacturing cell therapy products, and risks related to maintaining Nasdaq listing requirements [185][187][201] - The company issued 118,991 shares of Common Stock to satisfy a commitment fee and converted $5.8 million of convertible notes into 5,657,747 shares of Common Stock during the six months ended June 30, 2025 [210][211] Item 1. Legal Proceedings The company is not currently involved in any material legal proceedings, though it may encounter such matters in the ordinary course of business - The company is not currently party to any legal proceedings [183] - Legal proceedings, if they occur, could adversely affect the business, results of operations, financial position, or cash flows [183] Item 1A. Risk Factors This section updates risk factors, emphasizing going concern doubts, cell therapy manufacturing complexities, and Nasdaq listing compliance challenges, including minimum bid price requirements Risks Related to Our Financial Condition and Capital Requirements This section highlights the company's recurring losses and negative cash flows, creating substantial doubt about its ability to continue as a going concern - Recurring operating losses and negative cash flows since inception create substantial doubt about the company's ability to continue as a going concern for the next twelve months [185] - Continued operations depend on raising additional capital through equity, debt, or collaborations, with no assurance of availability or acceptable terms [185] - Inability to continue as a going concern could lead to delays, reduction, or discontinuation of R&D programs and loss of investment [186] Risks Related to Manufacturing This section addresses the complexities and risks associated with manufacturing cell therapy products, including production delays and regulatory compliance - Manufacturing cell therapy products is complex, requiring significant expertise and capital, and is subject to difficulties in production, sourcing, scaling, quality control, and compliance with regulations [188] - Timelines for the CYWC628 Phase 1/2 clinical trial in Australia have been extended due to process issues with manufacturing training runs and the need for additional sterility testing [188][194][197] - Reliance on third-party manufacturers for cGMP compliance and timely production increases risks, as their failure could lead to clinical holds, regulatory sanctions, delays, or inability to commercialize products [193][195][199] Risks Related to Ownership of Our Common Stock This section addresses risks related to common stock ownership, including Nasdaq listing compliance and potential delisting impacts - The company received a notification from Nasdaq on July 1, 2025, for non-compliance with the $1.00 minimum bid price requirement, with a deadline of December 29, 2025, to regain compliance [205][206] - Delisting from Nasdaq could severely limit market liquidity, make it difficult for stockholders to trade shares, negatively impact public perception, and hinder future capital raising efforts [208] - The company transferred its listing from the Nasdaq Global Market to the Nasdaq Capital Market on April 1, 2025, to meet less stringent listing requirements, but still faces challenges with the minimum bid price [201][203][204] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section details unregistered equity sales during the six months ended June 30, 2025, including common stock issued for a commitment fee and convertible note conversions - On January 7, 2025, the company issued 118,991 shares of Common Stock at $2.1010 per share to satisfy a $250,000 commitment fee under the SEPA [210] Summary of Unregistered Sales of Equity Securities (Conversions of Short-term Convertible Notes, Six Months Ended June 30, 2025) | Date | Tranche | Principal Amount (dollars) | Shares Issued (shares) | Price Per Share (dollars) | | :--------------- | :---------- | :--------------- | :------------ | :-------------- | | January 23, 2025 | Second Note | $900,000 | 552,113 | $1.6301 | | January 27, 2025 | Second Note | $500,000 | 317,238 | $1.5761 | | January 29, 2025 | Second Note | $500,000 | 334,336 | $1.4955 | | February 7, 2025 | Second Note | $1,100,000 | 732,941 | $1.5008 | | February 21, 2025 | Second Note | $250,000 | 232,169 | $1.0768 | | March 4, 2025 | Second Note | $350,000 | 361,794 | $0.9674 | | April 11, 2025 | Second Note | $200,000 | 263,643 | $0.7586 | | April 15, 2025 | Second Note | $200,000 | 263,643 | $0.7586 | | May 15, 2025 | Second Note | $300,000 | 388,450 | $0.7723 | | June 2, 2025 | Second Note | $100,000 | 147,579 | $0.6776 | | June 3, 2025 | Second Note | $300,000 | 442,739 | $0.6776 | | June 20, 2025 | Second Note | $100,000 | 144,216 | $0.6934 | | June 24, 2025 | Second Note | $200,000 | 295,377 | $0.6771 | | June 26, 2026 | Third Note | $300,000 | 443,066 | $0.6771 | | June 27, 2025 | Third Note | $500,000 | 738,443 | $0.6771 | Item 3. Defaults Upon Senior Securities The company reported no defaults upon senior securities during the period - There were no defaults upon senior securities [212] Item 4. Mine Safety Disclosures This item is not applicable to the company - This item is not applicable [213] Item 5. Other Information No directors or officers adopted or terminated Rule 10b5-1 trading plans or non-Rule 10b5-1 trading plans during the fiscal quarter - No directors or officers adopted or terminated Rule 10b5-1 trading plans or non-Rule 10b5-1 trading plans during the fiscal quarter [214] Item 6. Exhibits This section lists all exhibits filed as part of the Form 10-Q, including corporate governance documents, material agreements, certifications, and XBRL-related files - Exhibits include the Amended and Restated Certificate of Incorporation, Employment Agreement, Convertible Promissory Note, Consulting Agreement, and various certifications [216] - XBRL (eXtensible Business Reporting Language) documents are provided for interactive data filing [216] Signature This section confirms the official signing of the report by the Chief Financial Officer - The report was signed by Jason D. Davis, Chief Financial Officer, on July 31, 2025 [220]