Surrozen(SRZN) - 2025 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION This section presents Surrozen, Inc.'s unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations Item 1. Financial Statements This section presents Surrozen, Inc.'s unaudited condensed consolidated financial statements, including balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed explanatory notes Unaudited Condensed Consolidated Balance Sheets This table provides a snapshot of the company's financial position, detailing assets, liabilities, and stockholders' equity at specific reporting dates | Metric | June 30, 2025 (Unaudited) (in thousands) | December 31, 2024 (in thousands) | | :--------------------------------- | :--------------------------------------- | :----------------------------------- | | Assets: | | | | Cash and cash equivalents | $90,390 | $34,565 | | Total current assets | $94,235 | $38,932 | | Total assets | $102,696 | $48,467 | | Liabilities and Stockholders' Equity (Deficit): | | | | Total current liabilities | $5,743 | $7,315 | | Tranche liability | $10,903 | — | | Warrant liabilities | $32,620 | $55,892 | | Total liabilities | $55,582 | $69,847 | | Total stockholders' equity (deficit) | $47,114 | $(21,380) | | Total liabilities and stockholders' equity | $102,696 | $48,467 | Unaudited Condensed Consolidated Statements of Operations This table presents the company's financial performance over specific periods, including revenue, expenses, and net income or loss | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :---------------------------------------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Research service revenue – related party | $983 | $— | $1,966 | $— | | Research and development expenses | $6,042 | $5,335 | $12,600 | $10,582 | | General and administrative expenses | $3,958 | $3,714 | $7,934 | $7,597 | | Loss from operations | $(9,017) | $(9,049) | $(18,568) | $(18,179) | | Interest income | $1,025 | $490 | $1,321 | $875 | | Loss on issuance of common stock, pre-funded warrants and warrants in the 2024 PIPE | $— | $(20,397) | $— | $(20,397) | | Loss on amendment and cancellation of warrants | $— | $— | $(2,073) | $— | | Loss on execution of the 2025 PIPE | $— | $— | $(71,084) | $— | | Gain on change in fair value of tranche liability | $31,520 | $— | $47,860 | $— | | Gain on settlement of tranche liability | $— | $— | $1,117 | $— | | Other income, net | $16,218 | $3,695 | $54,203 | $3,610 | | Net income (loss) | $39,746 | $(25,261) | $12,776 | $(34,091) | | Net income (loss) per share, basic and diluted | $2.55 | $(7.99) | $0.85 | $(13.00) | Unaudited Condensed Consolidated Statements of Stockholders' Equity (Deficit) This table details changes in the company's equity over time, reflecting common stock, additional paid-in capital, and accumulated deficit | Metric | December 31, 2024 (in thousands) | June 30, 2025 (in thousands) | | :--------------------------------------- | :------------------------------- | :----------------------------- | | Common stock (shares) | 3,262 | 8,570 | | Common stock (amount) | $0 | $1 | | Additional paid-in capital | $263,879 | $319,596 | | Accumulated deficit | $(285,259) | $(272,483) | | Total stockholders' equity (deficit) | $(21,380) | $47,114 | - Issuance of common stock in 2025 PIPE: 5,213 shares, $53,189 in APIC[19] - Stock-based compensation expense: $1,828[19] - Net income: $12,776[19] Unaudited Condensed Consolidated Statements of Cash Flows This table summarizes the cash inflows and outflows from operating, investing, and financing activities over specific periods | Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(15,392) | $(14,357) | | Net cash used in investing activities | $(45) | $(7) | | Net cash provided by financing activities | $71,262 | $16,086 | | Net increase in cash, cash equivalents and restricted cash | $55,825 | $1,722 | | Cash, cash equivalents and restricted cash at end of period | $91,078 | $38,453 | Notes to Unaudited Condensed Consolidated Financial Statements This section provides detailed explanations and disclosures supporting the unaudited condensed consolidated financial statements Note 1. Organization and Business This note describes Surrozen, Inc.'s biotechnology focus on the Wnt pathway, its financial performance, and liquidity outlook - Surrozen, Inc. is a biotechnology company focused on modulating the Wnt pathway for tissue repair, with a current emphasis on ophthalmology[24] Financial Performance and Liquidity (in millions) | Metric | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net income (loss) | $39.7 | $12.8 | $(34.1) | | Noncash gains (tranche & warrant liabilities) | $47.6 | $104.6 | — | | Cash used in operations | — | $(15.4) | $(14.4) | | Cash and cash equivalents (as of June 30, 2025) | $90.4 | $90.4 | — | | Accumulated deficit (as of June 30, 2025) | $(272.5) | $(272.5) | — | - Management believes existing cash and cash equivalents are sufficient for at least the next 12 months, but additional capital will be needed for future operations and clinical studies[26] Note 2. Summary of Significant Accounting Policies This note details the basis of financial statement presentation, key accounting policies, and evaluation of recent accounting pronouncements - The financial statements are prepared under U.S. GAAP, with estimates for R&D accruals, tranche liability, and warrant fair values[27][30] - Tranche liability from the 2025 PIPE and warrant liabilities are classified as liabilities and remeasured at fair value each reporting period, with changes recognized in the statements of operations[34][35] - Basic and diluted net income (loss) per share are computed using the two-class method, considering pre-funded and certain PIPE warrants as participating securities[37][38] - The company is evaluating the impact of new FASB Accounting Standards Updates 2024-03 (Expense Disaggregation Disclosures) and 2023-09 (Income Tax Disclosures), effective for annual periods beginning after December 15, 2026 and 2024, respectively[39][40] Note 3. Fair Value Measurement This note explains the fair value measurements of financial assets and liabilities, including valuation methodologies for warrants and tranche liability Financial Assets and Liabilities Measured at Fair Value (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :-------------- | :---------------- | | Assets: | | | | Money market funds (Level 1) | $80,155 | $25,495 | | Liabilities: | | | | Tranche liability (Level 3) | $10,903 | — | | 2021 Public Warrants (Level 1) | $96 | $109 | | 2021 PIPE Warrants (Level 2) | $11 | $17 | | 2024 Pre-Funded Warrants (Level 2) | $358 | $574 | | 2024 PIPE Warrants (Level 3) | $7,856 | $55,192 | | 2025 Pre-Funded Warrants (Level 2) | $11,667 | — | | 2025 PIPE Warrants (Level 3) | $12,632 | — | | Total financial liabilities at fair value | $43,523 | $55,892 | - Level 3 liabilities (tranche liability, 2024 PIPE Warrants, 2025 PIPE Warrants) are valued using the Black-Scholes model with unobservable inputs like expected term, volatility, risk-free rate, dividend yield, and for some, milestone timing/probability[44][45] - The discontinuation of SZN-043 clinical development in Q1 2025 resulted in the fair value of Series C and D 2024 PIPE Warrants becoming zero. Amendments to Series A and B 2024 PIPE Warrants and their cancellation in connection with the 2025 PIPE led to a $2.1 million loss[48] Note 4. Balance Sheet Components This note provides a detailed breakdown of the company's accrued and other liabilities at specific reporting dates Accrued and Other Liabilities (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :-------------- | :---------------- | | Accrued payroll and related expenses | $2,114 | $2,929 | | Accrued research and development expenses | $1,652 | $1,904 | | Accrued professional service fees | $193 | $156 | | Other | $232 | $191 | | Total Accrued and other liabilities | $4,191 | $5,180 | Note 5. Collaboration and License Agreements This note details the collaboration and license agreement with Boehringer Ingelheim for Fzd4 bi-specific antibodies, including milestone and royalty terms - The company has a Collaboration and License Agreement (CLA) with Boehringer Ingelheim (BI) for Fzd4 bi-specific antibodies, including SZN-413[51] - Under the CLA, BI paid a non-refundable upfront payment of $12.5 million (received $10.5 million) and may pay up to $587.0 million in success-based milestones and mid-single to low-double digit royalties on net sales[52] - Revenue from future milestones is fully constrained due to the inherent uncertainty of success, and sales-based royalties will be recognized when related sales occur[53] Note 6. License Agreements This note describes the exclusive license agreement with Stanford University for engineered Wnt surrogate molecules, including potential milestone and royalty payments - The company holds an exclusive, sublicensable license from Stanford University for engineered Wnt surrogate molecules, covering patents and technology for treating human and veterinary diseases[54] - The Stanford Agreement includes potential payments of up to $0.9 million for development/regulatory milestones and up to $5.0 million for sales milestones, plus very low single-digit royalties on net sales[54][55] - As of June 30, 2025, de minimis R&D expenses were incurred, and no milestones have been achieved under the Stanford Agreement[56] Note 7. Commitments and Contingencies This note details the company's operating lease for its office and laboratory space, including lease terms, extension options, and future rental payments - The company has an operating lease for its office and laboratory space in South San Francisco, California, with a term ending in April 2029[57] - The lease includes an option to extend for four years and a one-time early termination option effective April 30, 2026, with a $0.4 million termination fee[57] Aggregate Future Minimum Rental Payments (in thousands) | Period | Amount | | :------------------------------------ | :----- | | Remaining six months ending Dec 31, 2025 | $1,162 | | Year ending Dec 31, 2026 | $1,797 | | Year ending Dec 31, 2027 | $2,461 | | Year ending Dec 31, 2028 | $2,547 | | Year ending Dec 31, 2029 | $857 | | Total lease payments | $8,824 | | Less: Imputed interest | $(1,310) | | Operating lease liabilities | $7,514 | Note 8. Stockholders' Equity This note outlines the company's equity transactions, including the 2025 and 2024 Private Placements (PIPEs) and their financial impact - The 2025 PIPE, executed March 24, 2025, aims to raise approximately $175.0 million to fund ophthalmology programs. The first tranche closed on March 26, 2025, generating approximately $71.2 million in net proceeds[60][61] - The second tranche of the 2025 PIPE, expected to raise $98.6 million, is contingent upon FDA clearance of the IND application for SZN-8141 by October 31, 2026[61][62] - The 2024 PIPE, closed in April 2024, generated approximately $17.5 million in gross proceeds but resulted in a $20.4 million loss on issuance because the fair value of warrants issued exceeded the proceeds received[65] Note 9. Related Party Transactions This note details transactions with related parties, including a research collaboration and a sublease agreement, due to shared affiliations - The company has a strategic research collaboration with TCGFB, Inc. for TGF-β antibody discovery, which is a related party transaction due to shared affiliations with The Column Group[66][68] Research Service Revenue – Related Party (in thousands) | Period | Amount | | :------------------------------- | :----- | | Three Months Ended June 30, 2025 | $1,000 | | Six Months Ended June 30, 2025 | $2,000 | - A sublease agreement with Nura Bio, Inc., also a related party, generated $0.2 million and $0.3 million in sublease income for the three and six months ended June 30, 2025, respectively, recognized as reductions to operating expenses[72] Note 10. Common Stock Warrants This note summarizes the company's outstanding common stock warrants, their terms, and the impact of recent amendments and cancellations Common Stock Warrants Outstanding (in thousands) | Type | June 30, 2025 | December 31, 2024 | | :-------------------------- | :-------------- | :---------------- | | 2021 Public Warrants | 5,117 | 5,117 | | 2021 PIPE Warrants | 791 | 790 | | 2024 Pre-Funded Warrants | 40 | 40 | | 2025 Pre-Funded Warrants | 1,305 | — | | 2024 PIPE Warrants – Series A | 1,132 | 1,132 | | 2024 PIPE Warrants – Series B | 1,231 | 1,231 | | 2024 PIPE Warrants – Series C | — | 4,386 | | 2024 PIPE Warrants – Series D | — | 4,386 | | 2025 PIPE Warrants – Series E | 3,293 | — | | Total | 12,909 | 17,082 | - The 2025 Pre-Funded Warrants have a nominal exercise price ($0.0001) and are immediately exercisable, while Series E common stock warrants have an exercise price of $11.54 and expire in five years[75] - Series C and D 2024 PIPE Warrants were cancelled in March 2025 due to the discontinuation of SZN-043 development, and exercise prices for Series A and B 2024 PIPE Warrants were reduced[77] - All outstanding warrants are classified as liabilities and measured at fair value, with changes recognized in other income, net[82] Note 11. Stock-Based Compensation Plans This note details the company's stock-based compensation plans, including option and RSU activity, and total compensation expense - As of June 30, 2025, 0.1 million shares were available under the 2021 Equity Incentive Plan and approximately 0.1 million shares under the 2021 Employee Stock Purchase Plan (ESPP)[83] Stock Option Activity (in thousands, except price) | Metric | December 31, 2024 | June 30, 2025 | | :-------------------------------- | :---------------- | :-------------- | | Options Outstanding (Number) | 536 | 1,220 | | Weighted Average Exercise Price | $19.45 | $14.80 | | Weighted Average Grant-Date Fair Value (6 months) | $7.45 (2024) | $8.97 (2025) | | Aggregate Intrinsic Value (Outstanding) | — | $36 | | Aggregate Intrinsic Value (Exercisable) | — | $13 | Total Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $340 | $350 | $606 | $649 | | General and administrative | $654 | $795 | $1,222 | $1,526 | | Total | $994 | $1,145 | $1,828 | $2,175 | - As of June 30, 2025, approximately $9.0 million of stock-based compensation expense remains to be recognized over a weighted-average period of 2.97 years[87] Note 12. Segment Reporting This note clarifies that the company operates as a single reportable segment focused on Wnt pathway drug candidate research and development - The company operates in one reportable segment: research and development of drug candidates to modulate the Wnt pathway for tissue repair and regeneration[88] Segment Profit or Loss 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 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenue | $983 | $— | $1,966 | $— | | Compensation (excl. stock-based) | $(3,283) | $(3,144) | $(6,613) | $(6,520) | | Development and manufacturing costs | $(1,509) | $(1,305) | $(3,619) | $(2,592) | | Stock-based compensation | $(994) | $(1,145) | $(1,828) | $(2,175) | | Other income (expense), including loss on execution of 2025 PIPE | $48,763 | $(16,214) | $31,344 | $(15,914) | | Segment and consolidated net income (loss) | $39,746 | $(25,261) | $12,776 | $(34,091) | - All research service revenue ($1.0 million for Q2 2025, $2.0 million for H1 2025) and long-lived assets are located in the United States[91] Note 13. Subsequent Event This note discloses the adoption of the 2025 Equity Inducement Plan by the board of directors for new employee equity awards - On August 7, 2025, the board adopted the 2025 Equity Inducement Plan, reserving 250,000 shares for new employee equity awards[92] - No awards have been granted under the Inducement Plan as of the filing date of this Quarterly Report[92] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's analysis of the company's financial condition and operational results, covering its biotechnology focus, performance, liquidity, capital resources, and regulatory status Overview This overview introduces Surrozen, Inc.'s biotechnology focus on Wnt pathway modulation, its key product candidates, and recent financial highlights - Surrozen is a biotechnology company focused on discovering and developing drug candidates to selectively modulate the Wnt pathway for tissue repair, with a current focus in ophthalmology[97][98] - Key product candidates include SZN-8141 (Fzd4 agonism + VEGF antagonism for retinal diseases, IND expected in 2026), SZN-8143 (Fzd4 agonism + VEGF antagonism + IL-6 antagonism for retinal diseases), and SZN-113 (Fzd127 target for Fuchs' Endothelial Corneal Dystrophy and Geographic Atrophy)[101][103][104] - SZN-413, a Fzd4 bi-specific antibody, is being developed under a collaboration with Boehringer Ingelheim, which triggered a $10.0 million milestone payment in September 2024[105] - Development of SZN-043 for severe alcohol associated hepatitis was discontinued in Q1 2025 due to insufficient early clinical benefit[106] Financial Summary (as of June 30, 2025, in millions) | Metric | Amount | | :-------------------- | :----- | | Accumulated deficit | $272.5 | | Cash and cash equivalents | $90.4 | Net Income (Loss) (in millions) | Period | Net Income (Loss) | | :------------------------------- | :---------------- | | Three Months Ended June 30, 2025 | $39.7 | | Six Months Ended June 30, 2025 | $12.8 | | Three Months Ended June 30, 2024 | $(25.3) | | Six Months Ended June 30, 2024 | $(34.1) | Note: 2025 net income includes noncash gains of $47.6 million (Q2) and $104.6 million (H1) on changes in fair value of tranche and warrant liabilities Results of Operations This section analyzes the company's financial performance, detailing changes in revenue, operating expenses, and net income or loss for the reported periods Key Financial Changes (Three Months Ended June 30, 2025 vs. 2024, in thousands) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :---------------------------------------------------------------- | :----- | :----- | :--------- | :--------- | | Research service revenue – related party | $983 | $— | $983 | * | | Research and development expenses | $6,042 | $5,335 | $707 | 13% | | General and administrative expenses | $3,958 | $3,714 | $244 | 7% | | Interest income | $1,025 | $490 | $535 | 109% | | Loss on issuance of common stock, pre-funded warrants and warrants in the 2024 PIPE | $— | $(20,397) | $20,397 | -100% | | Gain on change in fair value of tranche liability | $31,520 | $— | $31,520 | * | | Other income, net | $16,218 | $3,695 | $12,523 | * | | Net income (loss) | $39,746 | $(25,261) | $65,007 | * | *Percentage is not meaningful Key Financial Changes (Six Months Ended June 30, 2025 vs. 2024, in thousands) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :---------------------------------------------------------------- | :----- | :----- | :--------- | :--------- | | Research service revenue – related party | $1,966 | $— | $1,966 | * | | Research and development expenses | $12,600 | $10,582 | $2,018 | 19% | | General and administrative expenses | $7,934 | $7,597 | $337 | 4% | | Interest income | $1,321 | $875 | $446 | 51% | | Loss on issuance of common stock, pre-funded warrants and warrants in the 2024 PIPE | $— | $(20,397) | $20,397 | -100% | | Loss on amendment and cancellation of warrants | $(2,073) | $— | $(2,073) | * | | Loss on execution of the 2025 PIPE | $(71,084) | $— | $(71,084) | * | | Gain on change in fair value of tranche liability | $47,860 | $— | $47,860 | * | | Gain on settlement of tranche liability | $1,117 | $— | $1,117 | * | | Other income, net | $54,203 | $3,610 | $50,593 | * | | Net income (loss) | $12,776 | $(34,091) | $46,867 | * | *Percentage is not meaningful - Research and development expenses increased by $0.7 million (13%) for Q2 2025 and $2.0 million (19%) for H1 2025, primarily due to increased manufacturing costs, lab expenses, and consulting fees for ophthalmology programs, partially offset by decreased clinical expenses from the discontinuation of SZN-043[115][123] - Net income for Q2 and H1 2025 was significantly impacted by noncash gains on changes in fair value of tranche liability ($31.5 million for Q2, $47.9 million for H1) and warrant liabilities ($11.0 million for Q2, $51.7 million for H1)[119][120][129][131] Liquidity and Capital Resources This section discusses the company's historical funding, current cash position, future capital needs, and potential financing strategies - The company has incurred significant operating losses and negative cash flows from operations since inception, primarily financing activities through equity sales and collaboration payments[132] - The first tranche of the 2025 PIPE, closed in March 2025, generated approximately $71.2 million in net proceeds[133] - A second tranche of the 2025 PIPE, expected to provide $98.6 million, is contingent upon FDA clearance of the SZN-8141 IND application by October 31, 2026[133] - As of June 30, 2025, cash and cash equivalents were $90.4 million, and management believes this is sufficient to fund operations for at least the next 12 months[136] - The company will require substantial additional capital for future product candidate development, clinical trials, regulatory approvals, and commercialization, likely through equity offerings, debt financings, or collaborations, which could lead to stockholder dilution[135][136][138] Summary of Cash Flows (Six Months Ended June 30, in thousands) | Activity | 2025 | 2024 | | :-------------------------------- | :----- | :----- | | Net cash used in operating activities | $(15,392) | $(14,357) | | Net cash used in investing activities | $(45) | $(7) | | Net cash provided by financing activities | $71,262 | $16,086 | | Net increase in cash, cash equivalents and restricted cash | $55,825 | $1,722 | Emerging Growth Company Status This section explains the company's status as an Emerging Growth Company and Smaller Reporting Company, outlining associated regulatory exemptions - The company is an Emerging Growth Company (EGC) and a Smaller Reporting Company (SRC), allowing it to use exemptions from certain disclosure requirements and an extended transition period for new accounting standards[144][145][146][124][184][384][385][386] - The EGC status will be maintained until the earliest of December 31, 2025, or reaching specific revenue or market capitalization thresholds[147][384] Impact of Inflation This section addresses the impact of inflation on the company's labor, research, and clinical trial costs, and its overall financial condition - Inflation has increased labor costs, research and clinical trial costs, and is expected to continue to do so, potentially adversely affecting the company's financial condition and results of operations[149] Impact of Tariffs This section discusses the company's evaluation of potential tariff impacts, particularly concerning its UK-based contract manufacturing organization - The company is evaluating the potential impact of tariffs on its business, particularly as its contract manufacturing organization is located in the United Kingdom[150] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Surrozen, Inc. is not required to provide quantitative and qualitative disclosures about market risk - The company is exempt from providing quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company[151] Item 4. Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control - Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025[152] - There were no material changes in internal control over financial reporting during the quarter ended June 30, 2025[153] - The company acknowledges that disclosure controls and procedures provide reasonable, not absolute, assurance and may not prevent all errors or instances of fraud[154][155] PART II. OTHER INFORMATION This section covers other material information, including legal proceedings, risk factors, equity sales, defaults, and exhibits Item 1. Legal Proceedings The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business or financial condition - The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business[157] Item 1A. Risk Factors Investing in Surrozen, Inc. involves significant risks, including a history of losses, substantial funding needs, and uncertainties in product development and commercialization Summary of Risk Factors This section provides a concise overview of the material risks associated with investing in Surrozen, Inc., covering financial, operational, and regulatory challenges - The company has a history of losses and expects to incur significant losses for the foreseeable future, with no guarantee of achieving profitability[159][161] - Substantial additional funds are required to advance product candidates, and there is no guarantee of sufficient future funding, which could lead to dilution for existing stockholders[159][163][187] - None of the company's product candidates have received regulatory approval, and successful commercialization depends on obtaining such approvals, which is a lengthy, expensive, and uncertain process[159][169][334] - The company relies on third parties for preclinical studies, clinical trials, and manufacturing, and their unsatisfactory performance could cause delays or failures[159][197][217] - Competition from other pharmaceutical and biotechnology companies, including those with greater resources, poses a significant risk to the company's ability to develop and commercialize product candidates[159][225][227] - The company faces risks related to obtaining and protecting intellectual property rights, including challenges to patent validity, enforceability, and scope, as well as potential infringement claims from third parties[159][271][310] Item 2. Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities No unregistered sales of equity securities, use of proceeds, or issuer purchases occurred during the reporting period - No unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities occurred during the reporting period[393] Item 3. Defaults Upon Senior Securities There were no defaults upon senior securities during the period covered by this report - No defaults upon senior securities occurred during the reporting period[393] Item 4. Mine Safety Disclosures This item is not applicable to the company - This item is not applicable to the company[393] Item 5. Other Information No other information is reported under this item - No other information is reported under this item[393] Item 6. Exhibits This section lists all exhibits filed as part of the Form 10-Q, including corporate governance documents and certifications - The exhibits include corporate governance documents (Certificate of Incorporation, Bylaws), the Warrant Agreement, and certifications required by the Sarbanes-Oxley Act[395]