Spruce Biosciences(SPRB) - 2025 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Unaudited Condensed Financial Statements This section presents the unaudited condensed financial statements for Spruce Biosciences, Inc., including the balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows, along with detailed notes explaining the company's organization, accounting policies, financial instruments, and significant agreements Condensed Balance Sheets | ASSETS (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Cash and cash equivalents | $16,387 | $38,753 | | Total current assets | $20,953 | $44,206 | | Total assets | $21,820 | $45,209 | | LIABILITIES (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Total current liabilities | $8,060 | $15,246 | | Total liabilities | $8,640 | $16,388 | | Total stockholders' equity | $13,180 | $28,821 | Condensed Statements of Operations and Comprehensive Loss | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Collaboration revenue | $— | $1,610 | $— | $3,612 | | Total operating expenses | $2,692 | $11,646 | $17,184 | $26,281 | | Loss from operations | $(2,692) | $(10,036) | $(17,184) | $(22,669) | | Net loss and comprehensive loss | $(2,067) | $(9,181) | $(16,108) | $(20,806) | | Net loss per share, basic and diluted | $(3.50) | $(16.73) | $(27.36) | $(37.94) | Condensed Statements of Stockholders' Equity - Total stockholders' equity decreased from $28,821 thousand as of January 1, 2025, to $13,180 thousand as of June 30, 2025, primarily due to a net loss of $16,108 thousand[15] - Stock-based compensation for the six months ended June 30, 2025, was $467 thousand, a decrease from $3,247 thousand in the same period of 2024[15][16] Condensed Statements of Cash Flows | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(21,555) | $(26,064) | | Net cash used in financing activities | $(811) | $(592) | | Net decrease in cash, cash equivalents, and restricted cash | $(22,366) | $(26,656) | | Cash, cash equivalents, and restricted cash at end of period | $16,422 | $69,718 | Notes to the Unaudited Condensed Financial Statements 1. Organization and Principal Activities - Spruce Biosciences, Inc. is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders[22] - The company's common stock was delisted from Nasdaq on April 29, 2025, due to non-compliance with the minimum bid price requirement and began trading on the OTCQB under 'SPRBD' after a 1:75 reverse stock split effective August 7, 2025[23][24] - A workforce reduction of 55% was effected on April 21, 2025, to prioritize the development of tralesinidase alfa enzyme replacement therapy for Sanfilippo Syndrome Type B, incurring $0.9 million in operating expenses for the three months ended June 30, 2025[27] - The company incurred a net loss of $16.1 million and used $21.6 million cash in operations for the six months ended June 30, 2025, resulting in an accumulated deficit of $266.4 million; cash and cash equivalents of $16.4 million as of June 30, 2025, are insufficient to fund operations for the next 12 months, raising substantial doubt about its ability to continue as a going concern[28][29] 2. Summary of Significant Accounting Policies - The financial statements are prepared in accordance with U.S. GAAP and SEC interim reporting rules, with certain notes condensed or omitted[31] - The company operates as one reportable segment, focusing on developing and commercializing novel therapies for neurological disorders[38] - As an emerging growth company, Spruce Biosciences has elected to use the extended transition period for complying with new or revised accounting standards until December 31, 2025, or earlier if it loses emerging growth company status[41] 3. Fair Value Measurements | (in thousands) | June 30, 2025 | December 31, 2024 | | :------------- | :------------ | :---------------- | | Cash equivalents: Money market funds | $15,814 | $37,802 | | Warrant liability | $129 | $— | - The warrant liability, valued using a Black-Scholes option pricing model, was $129 thousand as of June 30, 2025, reflecting a change in fair value of $(619) thousand for the period[50][52] 4. Balance Sheet Components | Accrued Expenses and Other Current Liabilities (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------------------------ | :------------ | :---------------- | | Accrued research and development expenses | $4,287 | $10,635 | | Accrued general and administrative expenses | $483 | $529 | | Accrued compensation and benefits | $817 | $882 | | Warrant liability | $129 | $— | | Accrued final payment on term loan | $294 | $— | | Lease liabilities, current portion | $300 | $283 | | Total accrued expenses and other current liabilities | $6,310 | $12,329 | 5. Leases - The company leases office space in South San Francisco under a non-cancelable operating lease expiring in February 2028[55] 6. Term Loan - The Term Loan with Silicon Valley Bank, initially $4.5 million, was amended to $30.0 million (First Tranche $20.0 million, Second Tranche $10.0 million which expired); the loan matures on January 1, 2026[56][58] - As of June 30, 2025, the carrying value of the Term Loan was $0.9 million, with a stated interest rate of 8.0%[60][61] | Year ending December 31, | Future Payments (in thousands) | | :----------------------- | :----------------------------- | | 2025 (remaining 6 months) | $836 | | 2026 | $136 | | Total | $972 | | Less: interest | $(26) | | Less: unamortized debt issuance costs | $(3) | | Term loan, current portion | $943 | 7. License and Purchase Agreements - The company has a license agreement with Eli Lilly and Company for CRF1 receptor antagonist compounds, requiring up to $23.0 million in milestones and tiered royalties[66][67] - Under the Kaken License Agreement, the company granted exclusive rights for tildacerfont in Japan, receiving a $15.0 million upfront payment in April 2023 and eligible for up to $65.0 million in milestones and double-digit royalties; the full transaction price was recognized as of December 31, 2024[69][70][71] - A collaboration with HMNC Holding GmbH was formed in May 2024 to fund a Phase 2 study of tildacerfont in MDD patients using a genetic selection tool, with topline results anticipated in H1 2026[72][73][238] - In October 2024, the company acquired intellectual property and inventory related to Allievex's product candidates for $5.0 million, assuming up to $88.0 million in development/regulatory milestones and $100.0 million in sales milestones to BioMarin, plus tiered royalties[75][76][78] - An antibody license agreement with Twist Bioscience Corporation was entered in December 2024, with a $0.5 million payment recognized as R&D expense; the exercise period for the Twist Option was extended to December 2025[80][81][82] - A collaboration and license agreement with HBM Alpha Therapeutics, Inc. in January 2025 involved a $5.0 million upfront payment and issuance of pre-funded warrants, recognized as R&D expense; the company is obligated to pay up to $390.0 million in milestones and tiered royalties[85][86][87][88] 8. Capital Structure - As of June 30, 2025, the company had 563,042 shares of common stock outstanding, with 200,000,000 shares authorized[10][90] | Common Stock Reserved for Future Issuance | June 30, 2025 | December 31, 2024 | | :---------------------------------------- | :------------ | :---------------- | | Common stock warrants, issued and outstanding | 197,249 | 169,154 | | Stock options, issued and outstanding | 42,907 | 46,122 | | Restricted stock units, issued and outstanding | 25,512 | 29,880 | | Shares available for future issuance under 2020 Equity Incentive Plan | 63,295 | 27,558 | | Shares available for future issuance under 2020 Employee Stock Purchase Plan | 18,016 | 12,386 | | Total shares reserved | 346,979 | 285,100 | - One share of Series A Preferred Stock was issued on May 28, 2025, with 22,000,000 votes solely on reverse stock split proposals, and was redeemed for $100.00 on July 22, 2025, following stockholder approval of the reverse stock split[91][92][94][98] 9. Stock-Based Compensation Expense | (in thousands) | 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 | $(424) | $684 | $(298) | $1,263 | | General and administrative | $347 | $1,001 | $765 | $1,984 | | Total stock-based compensation expense | $(77) | $1,685 | $467 | $3,247 | 10. Net Loss Per Share | (in thousands, except share and per share amounts) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(2,067) | $(9,181) | $(16,108) | $(20,806) | | Weighted-average shares of common stock outstanding | 591,137 | 548,789 | 588,653 | 548,344 | | Net loss per share, basic and diluted | $(3.50) | $(16.73) | $(27.36) | $(37.94) | - Basic and diluted net loss per share were the same for all periods due to the anti-dilutive effect of potentially dilutive securities[97] 11. Related Party Transactions - The company recognized $0.3 million in compensation expense during the six months ended June 30, 2025, for Kirk Ways, M.D., a Board member serving as interim Chief Medical Officer[99] 12. Subsequent Events - The 1:75 reverse stock split became effective on August 7, 2025, with trading on OTCQB under 'SPRBD'[100] - The Series A Preferred Stock was redeemed on July 22, 2025, for $100.00 following stockholder approval of the reverse stock split[101] - The Twist Antibody License Agreement was amended in July 2025 to extend the exercise period for the Twist Option to December 2025[102] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition and operational results, highlighting significant losses, liquidity challenges, and strategic shifts towards developing tralesinidase alfa (TA-ERT); it also details the impact of the reverse stock split, material agreements, and changes in revenue and expenses Overview - Spruce Biosciences is a late-stage biopharmaceutical company focused on neurological disorders, with a recent shift in focus to tralesinidase alfa (TA-ERT) development since November 2024[107][108] - The company has incurred significant net losses since inception, with $16.1 million for the six months ended June 30, 2025, and an accumulated deficit of $266.4 million, expecting continued losses[109] - Cash and cash equivalents of $16.4 million as of June 30, 2025, are insufficient to fund operations for the next 12 months, indicating substantial doubt about the company's ability to continue as a going concern[111] - Pursue regulatory approval of TA-ERT in patients with MPSIIIB[111][123] - Build a specialized commercial organization for TA-ERT in the United States[111][123] - Advance TA-ERT through a planned confirmatory study in MPSIIB and expanded access programs[111][123] - Expand manufacturing capacity for TA-ERT[111][123] - Advance clinical development of tildacerfont in major depressive disorder (MDD)[111][123] - Advance pre-clinical and clinical development of SPR202 in congenital adrenal hyperplasia (CAH)[111][123] - Implement operational, financial, and management information systems[111][123] - Hire additional personnel[111][123] - Obtain, maintain, expand, and protect intellectual property portfolio[111][123] Reverse Stock Split - A one-for-seventy-five (1:75) reverse stock split was effected, with common stock trading on the OTCQB under 'SPRBD' since August 7, 2025; the company aims to resume trading on Nasdaq Capital Market by complying with the minimum bid price requirement[115][116] Material Agreements - The Term Loan with Silicon Valley Bank, initially $4.5 million, was increased to $30.0 million (First Tranche $20.0 million, Second Tranche $10.0 million which expired); as of June 30, 2025, $0.9 million principal was outstanding[118][119][121] - The loan matures on January 1, 2026, with a floating interest rate (greater of 0.50% above Prime Rate or 3.75%) and includes a $0.3 million Supplemental Final Payment[119][122][125] Components of Results of Operations - All revenue to date has been from the Kaken License Agreement, with no product revenue generated from commercial sales[126][127] - Operating expenses are categorized into research and development (R&D) and general and administrative (G&A); R&D expenses are primarily for advancing tildacerfont and acquiring/developing TA-ERT, expected to increase significantly[128][129] - G&A expenses include personnel costs, legal fees, professional fees, and public company compliance costs, also expected to increase[131][133] - Interest and other income, net, includes interest earned on cash and cash equivalents and changes in the fair value of warrant liability[135] Results of Operations | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Collaboration revenue | $— | $1,610 | $— | $3,612 | | Research and development | $(430) | $8,090 | $10,407 | $18,407 | | General and administrative | $3,122 | $3,556 | $6,777 | $7,874 | | Net loss | $(2,067) | $(9,181) | $(16,108) | $(20,806) | - Collaboration revenue decreased by $1.6 million (3 months) and $3.6 million (6 months) as the full transaction price from the Kaken License Agreement was recognized by December 31, 2024[137][138] - Research and development expenses decreased by $8.5 million (3 months) and $8.0 million (6 months) primarily due to decreased tildacerfont CAH development activities and reductions in Allievex acquisition liabilities, partially offset by SPR202 acquisition costs[139][141] - General and administrative expenses decreased by $0.4 million (3 months) and $1.1 million (6 months) mainly due to lower stock-based compensation expense[142][144] - Interest and other income, net, decreased by $0.3 million (3 months) and $0.9 million (6 months) due to lower interest income from money market funds, partially offset by a gain from the decrease in warrant liability fair value[145] Liquidity and Capital Resources - The company had $16.4 million in cash and cash equivalents as of June 30, 2025, down from $38.8 million at December 31, 2024; this is insufficient to fund operations for the next 12 months, raising substantial doubt about its going concern ability[146][147] - Since inception, the company has raised $293.1 million gross proceeds, including $103.5 million from IPO, $116.0 million from preferred stock, $5.0 million from debt, $53.6 million from a private placement, and $15.0 million from the Kaken upfront payment[146] - Future funding requirements are substantial for clinical development and commercialization of product candidates, with no meaningful product revenue expected soon; additional capital may be sought through equity, debt, or collaborations[148][149][150] - As of June 30, 2025, material cash requirements include $1.0 million for the Term Loan (maturing Jan 2026) and $1.0 million for operating lease payments (expiring Feb 2028)[156][157] | Cash Flows (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(21,555) | $(26,064) | | Net cash used in financing activities | $(811) | $(592) | | Net decrease in cash, cash equivalents, and restricted cash | $(22,366) | $(26,656) | - Net cash used in operating activities decreased by $4.5 million, primarily due to lower clinical development payments offset by asset acquisition payments[161] - Net cash used in financing activities increased to $0.8 million, mainly from Term Loan principal payments, compared to $0.6 million in 2024 which included stock option proceeds[162] Critical Accounting Estimates - The preparation of financial statements requires estimates and assumptions, including for accrued R&D expenses, revenue recognition, stock-based compensation, and uncertain tax positions; no significant changes to critical accounting estimates occurred during the six months ended June 30, 2025[163][165] JOBS Act - As an 'emerging growth company' under the JOBS Act, Spruce Biosciences utilizes reduced reporting requirements and has elected the extended transition period for new accounting standards until December 31, 2025, or earlier if its status changes[166][167] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section discusses the company's exposure to market risks, specifically interest rate risk, foreign currency exchange rate risk, and the effects of inflation, concluding that these risks did not have a material impact on financial statements for the periods presented - The company's cash and cash equivalents are primarily in bank deposits and money market funds, carrying interest rate risk; a hypothetical 1% change in interest rates would not materially affect financial statements as of June 30, 2025[169][170] - Operations are primarily in the U.S., with some foreign currency denominated invoices, but foreign currency exchange rate changes had no material impact[171] - Inflation affects labor and clinical trial costs, but did not have a significant impact on results of operations for the periods presented, and no material effect is expected for future reporting periods as of June 30, 2025[172] Item 4. Controls and Procedures Management, with CEO and CFO participation, evaluated the effectiveness of disclosure controls and procedures as of June 30, 2025, concluding they are effective; no material changes in internal control over financial reporting occurred during the quarter - Disclosure controls and procedures were evaluated and deemed effective as of June 30, 2025, providing reasonable assurance for timely and accurate information reporting[173] - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[174] - Management acknowledges that controls and procedures provide only reasonable, not absolute, assurance due to inherent limitations and resource constraints[175] PART II. OTHER INFORMATION Item 1. Legal Proceedings The company is not currently a party to any material legal proceedings, though it may become involved in the ordinary course of business; litigation, regardless of outcome, can negatively impact the business - The company is not currently involved in any material legal proceedings[177] - Litigation, even if not material, can adversely affect the business due to defense/settlement costs, diversion of management resources, and reputational harm[177] Item 1A. Risk Factors This section details significant risks that could adversely affect the company's business, financial condition, and stock price; key areas of risk include stock ownership, business operations and industry-specific challenges, and intellectual property protection Risks Related to Ownership of Our Common Stock - Failure to regain Nasdaq compliance could lead to delisting, reducing market liquidity and stock price[179][183] - The trading price of common stock has been, and may continue to be, highly volatile due to various factors including clinical trial results, regulatory decisions, and market conditions[185][190] - The company does not intend to pay dividends, limiting stockholder returns to stock value appreciation[191][193] - Principal stockholders and management own a significant percentage of stock, allowing them to exert substantial control over stockholder-approved matters[196][205] - As an emerging growth company and smaller reporting company, reduced reporting requirements may make the common stock less attractive to investors[208] - Failure to maintain effective internal control over financial reporting could adversely affect investor confidence and stock value[208] - Future sales and issuances of common stock or rights to purchase common stock could result in additional dilution for existing stockholders and cause the stock price to fall[208] - Anti-takeover provisions in charter documents and Delaware law could delay or prevent a change of control[208] Risks Related to Our Business and Industry - Substantial doubt exists about the company's ability to continue as a going concern due to insufficient working capital for the next twelve months[214][216] - Significant additional financing is required for product candidate development and commercialization; failure to obtain it may force delays or elimination of programs[222][224] - The company has a limited operating history, significant net losses since inception, and anticipates continued losses, which are expected to increase with clinical development[225][239] - Inability to advance product candidates (TA-ERT, tildacerfont, SPR202) in clinical development, obtain regulatory approval, or commercialize them, or significant delays, would materially harm the business[240][242] - Clinical trials may fail to demonstrate adequate safety and efficacy, preventing or delaying regulatory approval[243][244] - Significant competition from other biotechnology and pharmaceutical companies could adversely affect operating results[248][249] - Preclinical and clinical drug development is lengthy, expensive, and uncertain; earlier trial results may not predict future outcomes[251][254] - Difficulties enrolling patients in clinical trials, especially for rare disorders like MPS-IIIB, could delay or adversely affect development activities[255][264] - Delays in clinical trials could increase costs, limit revenue generation, and harm commercial prospects[268][270] - Product candidates are subject to extensive, costly, and time-consuming regulation and compliance obligations, which may cause delays or prevent approvals[271][272] - Interim, topline, and preliminary clinical trial data may change, and final data could differ materially[273][274](index=274&type=chunk] - If market opportunities for product candidates are smaller than believed, future revenue may be adversely affected[276][277] - Obtaining regulatory approval in one jurisdiction does not guarantee success in others, and failure in one may negatively impact others[278][284] - Lack of a marketing and sales organization and inability to establish one or partner with third parties could prevent product revenue generation[288][292] - Unfavorable U.S. and global economic/geopolitical conditions (e.g., inflation, wars, banking instability) could adversely affect business and financial condition[294][295] - International trade policies, including tariffs and trade barriers, may increase R&D expenses, disrupt supply chains, and delay development timelines[300][301] - High dependence on key personnel; failure to attract and retain qualified individuals could hinder business strategy implementation[302][303] - Side effects or adverse events associated with product candidates could delay/prevent regulatory approval or lead to negative consequences post-approval[306][307](index=307&type=chunk] - Ongoing regulatory obligations and review post-approval may result in significant additional expense and penalties for non-compliance[308][309] - Changes in funding for regulatory agencies or government shutdowns could hinder timely review and approval of products[311][312] - Even with regulatory approval, product candidates may not gain market acceptance among physicians, patients, and payors[317][318] - Improper promotion of off-label uses or off-label prescription could lead to sanctions, fines, and reputational harm[330][331](index=331&type=chunk] - Limited or unavailable coverage and reimbursement in certain market segments could hinder profitable sales[335][336] - Current and future legislation and healthcare reform measures may increase difficulty and cost of obtaining approval and affect pricing[337][339](index=339&type=chunk] - Failure to obtain regulatory approval in international jurisdictions would prevent international marketing[340][341] - Risks associated with international marketing (e.g., differing regulations, economic instability, foreign currency fluctuations) could adversely affect profitability[343][344] - Failure to develop and commercialize additional product candidates could limit business growth[345][346] - Future strategic alliances or licensing arrangements may not be successful[350][351] - Difficulties in managing organizational growth could adversely affect financial performance and commercialization ability[361][364] - Indebtedness to Silicon Valley Bank (SVB) may limit operational flexibility, and default could lead to foreclosure on assets[366][376](index=376&type=chunk] - Business disruptions (e.g., natural disasters, epidemics) could harm future revenues and increase costs[377][378] - Misconduct by employees, contractors, or vendors, including noncompliance with regulatory standards, could lead to significant penalties[379][380](index=380&type=chunk] - Compromised information technology systems or data could result in regulatory actions, litigation, and business disruptions[380] - Stringent and evolving data privacy and security obligations could lead to regulatory investigations, litigation, and adverse business consequences[380] - Product liability lawsuits could result in substantial liabilities and limit commercialization[380] - Compliance with U.S. and foreign export/import controls, sanctions, anti-corruption, and anti-money laundering laws is critical; violations can lead to criminal liability and harm business[380] Risks Related to Our Intellectual Property - Inability to obtain and maintain sufficient intellectual property protection for product candidates and technologies could allow competitors to commercialize similar products[400][401] - Patent terms may be inadequate to protect competitive position for a sufficient amount of time, especially given lengthy development and regulatory review[405][415] - Failure to obtain patent term extension for product candidates could materially harm the business by shortening exclusive marketing rights[416][417] - Non-compliance with obligations in intellectual property license agreements (e.g., with Lilly, HBM) or disruptions with licensors could lead to loss of significant rights[419][423] - Failure to comply with procedural, document submission, and fee payment requirements by governmental patent agencies could reduce or eliminate patent protection[424][427] - Changes in U.S. patent law (e.g., America Invents Act, Supreme Court decisions) could diminish the value of patents, impairing protection for product candidates[428][433] - Inability to protect intellectual property rights globally due to varying national laws and enforcement challenges could limit commercial advantage[434][435] - Claims challenging inventorship or ownership of patents and other intellectual property could lead to loss of rights or substantial costs[441][442] - Inability to obtain or maintain necessary rights to product components and processes through acquisitions and in-licenses could hinder development pipeline growth[445][448] - Third-party claims alleging intellectual property infringement may prevent or delay drug discovery and development efforts, leading to costly litigation or licensing requirements[449][452](index=452&type=chunk] - Inability to protect the confidentiality of trade secrets, especially when shared with third parties, would harm business and competitive position[453][454] - Inadequate protection of trademarks and trade names could impede name recognition and adversely affect the business[455][456] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section notes that the company is prohibited from paying cash dividends without prior written consent from Silicon Valley Bank, as per the Loan Agreement - The company is prohibited from paying cash dividends without the prior written consent of Silicon Valley Bank, as stipulated in the Loan Agreement[477] Item 3. Defaults Upon Senior Securities This item is not applicable to the company for the reporting period Item 4. Mine Safety Disclosures This item is not applicable to the company for the reporting period Item 5. Other Information No other information is reported under this item Item 6. Exhibits This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including amendments to the Certificate of Incorporation, Bylaws, Certificate of Designation for Series A Preferred Stock, various agreements, and certifications - Key exhibits include amendments to the Certificate of Incorporation (July 24, 2025), Certificate of Designation of Series A Preferred Stock (May 29, 2025), Purchase Agreement (May 29, 2025), and First Amendment to Antibody License Agreement (July 28, 2025)[481]