Table of Contents Sagimet Biosciences Inc. UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41742 (Exact name of registrant as specified in its charter) (State or other jurisdic ...

[Q2 2025 Earnings Release Overview](index=1&type=section&id=Q2%202025%20Earnings%20Release%20Overview) [Key Financial Highlights](index=1&type=section&id=Key%20Financial%20Highlights) BrainsWay achieved record quarterly revenue of $12.6 million in Q2 2025, an increase of 26% compared to Q2 2024, alongside positive operating profit and increased Adjusted EBITDA Key Financial Highlights (Millions) | Metric | Q2 2025 (Millions) | | :---------------- | :----------------- | | Revenue | $12.6 | | Operating Profit | $0.6 | | Adjusted EBITDA | $1.5 | - Achieved record quarterly revenue of **$12.6 million** in Q2 2025, an increase of **26%** compared to Q2 2024[1](index=1&type=chunk) [Key Operational Highlights](index=1&type=section&id=Key%20Operational%20Highlights) The company reported a significant year-over-year increase in remaining performance obligations, indicating strong future revenue streams from multi-year agreements - Remaining performance obligations increased by **25%** year-over-year to **$62 million**[1](index=1&type=chunk) [Updated Full-Year 2025 Guidance](index=1&type=section&id=Updated%20Full-Year%202025%20Guidance) BrainsWay raised its full-year 2025 revenue and EBITDA guidance, reflecting improved visibility and business momentum - Raised full-year 2025 Revenue and EBITDA guidance[1](index=1&type=chunk) [Recent Financial and Operational Highlights](index=1&type=section&id=Recent%20Financial%20and%20Operational%20Highlights) [Q2 2025 Financial Performance](index=1&type=section&id=Q2%202025%20Financial%20Performance) BrainsWay reported strong Q2 2025 financial results, with significant year-over-year growth in revenue, net profit, and Adjusted EBITDA, while maintaining a high gross margin Q2 2025 Financial Performance (Millions) | Metric | Q2 2025 | Q2 2024 | YoY Change | | :------------------------------------------------------- | :------ | :------ | :--------- | | Revenue | $12.6M | $10.0M | +26% | | Gross Margin | 75% | 75% | 0% | | Operating Income | $0.6M | $0.6M | 0% | | Adjusted EBITDA | $1.5M | $1.3M | +16% | | Net Profit | $2.0M | $0.6M | +233% | | Cash, Cash Equivalents, Restricted Cash, and Short-term Deposits (as of June 30, 2025) | $78.3M | N/A | N/A | [Q2 2025 Operational Achievements](index=1&type=section&id=Q2%202025%20Operational%20Achievements) The company significantly increased its Deep TMS system shipments and expanded its installed base, with a majority of new customer engagements structured as multi-year lease agreements - Shipped a net total of **88 Deep TMS™ systems** in the second quarter of 2025, a **35% increase** compared to the same period last year, bringing the total installed base to **1,522 systems**[6](index=6&type=chunk) - Approximately **70%** of recent customer engagements are structured as multi-year lease agreements, contributing to **$62 million** in remaining performance obligations[6](index=6&type=chunk) [Strategic Initiatives and Business Momentum](index=1&type=section&id=Strategic%20Initiatives%20and%20Business%20Momentum) BrainsWay is actively pursuing strategic minority equity investments in high-performing mental health providers and made progress with regulatory submissions and clinical programs - Entered an equity financing transaction with Stella MSO, LLC, a management services organization servicing over **20 mental health clinics**[6](index=6&type=chunk) - Actively seeking to ramp up strategic initiative with additional minority equity investments in high-performing mental health providers, partnering with Valor Equity Partners[6](index=6&type=chunk) - Submitted data to the FDA from its randomized, multicenter U.S. clinical trial evaluating an accelerated Deep TMS treatment protocol[6](index=6&type=chunk) - Continued progress with Israel Ministry of Defense's Rehabilitation Department in qualifying patients with post-traumatic stress disorder (PTSD) for Deep TMS[6](index=6&type=chunk) [Full-Year 2025 Financial Guidance](index=1&type=section&id=Full-Year%202025%20Financial%20Guidance) BrainsWay raised its full-year 2025 financial guidance, projecting higher revenue, operating income, and Adjusted EBITDA, driven by strong Q2 results and improved business momentum Full-Year 2025 Financial Guidance | Metric | New Guidance (2025) | Previous Guidance (2025) | | :---------------- | :---------------------- | :----------------------- | | Revenue | $50M - $52M | $49M - $51M | | Operating Income | 4% - 5% | 3% - 4% | | Adjusted EBITDA | 12% - 13% | 11% - 12% | [Management Commentary](index=1&type=section&id=Management%20Commentary) [Q2 Performance and Growth Strategy](index=1&type=section&id=Q2%20Performance%20and%20Growth%20Strategy) CEO Hadar Levy highlighted strong Q2 results, attributing success to momentum in the core market, successful execution of the growth strategy, and stable recurring revenue streams from multi-year agreements - BrainsWay's second quarter results were strong, demonstrating momentum across the core market and successful execution of the growth strategy[4](index=4&type=chunk) - The stable growth reflects recurring revenue streams built over the past few years through multi-year agreements, which now make up approximately **70%** of the new installed base[4](index=4&type=chunk) - Achieved an extensive order of systems with a multi-phased delivery plan through the end of the year by a fast-growing U.S. mental health network[4](index=4&type=chunk) [Strategic Equity Investments](index=1&type=section&id=Strategic%20Equity%20Investments) Mr. Levy emphasized the strategic initiative to secure minority equity investments in high-performing mental health providers, aiming to significantly increase patient awareness of Deep TMS technology - Successes have given rise to exciting new opportunities, including a strategic initiative aimed at securing minority equity investments in high-performing mental health providers[5](index=5&type=chunk) - This program has already led to several opportunities being explored and is expected to significantly increase awareness among patients of the benefits of transformative care, including Deep TMS technology[5](index=5&type=chunk) [Conference Call and Webcast](index=1&type=section&id=Conference%20Call%20and%20Webcast) BrainsWay's management hosted a conference call on August 13, 2025, to discuss the Q2 results, with details provided for accessing the call via phone and webcast - BrainsWay's management hosted a conference call on **Wednesday, August 13, 2025, at 8:30 a.m. Eastern Time** to discuss results and answer questions[6](index=6&type=chunk) - Dial-in numbers were provided for the United States, International, and Israel, along with a Conference ID[7](index=7&type=chunk) - The conference call was broadcast live and made available for replay for **30 days** on the Company's investor relations website[7](index=7&type=chunk) [Non-IFRS Financial Measures](index=2&type=section&id=Non-IFRS%20Financial%20Measures) [Definition and Purpose of Adjusted EBITDA](index=2&type=section&id=Definition%20and%20Purpose%20of%20Adjusted%20EBITDA) Adjusted EBITDA is presented as a non-IFRS measure to evaluate operating performance, defined as net profit adjusted for specific non-operating and non-cash items, providing a clearer view of operational efficiency and comparability - Adjusted EBITDA is a non-IFRS measure defined as net profit adjusted for depreciation and amortization, finance income, finance expenses, income taxes, cost of share-based payments, and one-time restructuring and litigation expenses[8](index=8&type=chunk) - It is used by management and investors for period-to-period comparisons, understanding operating results, and assessing operational efficiency, as it excludes items that can vary substantially between companies[9](index=9&type=chunk)[13](index=13&type=chunk) - Adjusted EBITDA should not be considered an alternative to operating profit or net profit under IFRS and may not be comparable to similarly titled measures from other companies[9](index=9&type=chunk)[10](index=10&type=chunk) [About BrainsWay](index=2&type=section&id=About%20BrainsWay) BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep TMS™ technology with three FDA-cleared indications, and is committed to advancing neuroscience through clinical evidence and global access - BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology[11](index=11&type=chunk) - The company is the first and only TMS company to obtain **three FDA-cleared indications** backed by pivotal clinical studies: major depressive disorder (including anxious depression), obsessive-compulsive disorder, and smoking addiction[11](index=11&type=chunk) - BrainsWay is dedicated to leading through superior science, building on its clinical evidence, and conducting additional clinical trials for Deep TMS in various psychiatric, neurological, and addiction disorders[11](index=11&type=chunk) [Forward-Looking Statement](index=2&type=section&id=Forward-Looking%20Statement) This section contains standard forward-looking statements, which are subject to various factors and uncertainties that could cause actual results to differ materially from projections, and the company undertakes no obligation to update them - This press release contains "forward-looking statements" under the Private Securities Litigation Reform Act of 1995, including financial guidance and projections[12](index=12&type=chunk) - These statements are based on current management expectations and are subject to numerous factors and uncertainties that could cause actual results to differ materially from those described[12](index=12&type=chunk) - The company undertakes no obligation to publicly update or review any forward-looking statement, except as may be required by applicable securities laws[15](index=15&type=chunk) [Contacts](index=3&type=section&id=Contacts) Contact information for BrainsWay's Chief Financial Officer and Investor Relations is provided for inquiries - BrainsWay Contact: Ido Marom, Chief Financial Officer (Ido.Marom@BrainsWay.com)[16](index=16&type=chunk) - Investors Contact: Brian Ritchie, LifeSci Advisors LLC (britchie@lifesciadvisors.com)[16](index=16&type=chunk) [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) [Consolidated Statements of Financial Position (Balance Sheet)](index=4&type=section&id=Consolidated%20Statements%20of%20Financial%20Position) The balance sheet shows an increase in total assets to $111.56 million as of June 30, 2025, primarily driven by an increase in current assets and investments in financial assets, with a corresponding increase in deferred revenues and equity Consolidated Statements of Financial Position (U.S. dollars in thousands) | Metric (U.S. dollars in thousands) | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | Change | | :--------------------------------- | :------------------------ | :-------------------------- | :----- | | **ASSETS** | | | | | Current Assets | $89,490 | $79,670 | +$9,820 | | Non-Current Assets | $22,074 | $14,646 | +$7,428 | | **Total Assets** | **$111,564** | **$94,316** | **+$17,248** | | **LIABILITIES AND EQUITY** | | | | | Current Liabilities | $25,508 | $15,346 | +$10,162 | | Non-Current Liabilities | $17,924 | $16,657 | +$1,267 | | Equity | $68,132 | $62,313 | +$5,819 | | **Total Liabilities and Equity** | **$111,564** | **$94,316** | **+$17,248** | [Consolidated Statements of Comprehensive Profit (Loss) (Income Statement)](index=5&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Profit%20(Loss)) For Q2 2025, BrainsWay reported significant revenue growth and a substantial increase in net profit compared to the prior year, primarily driven by higher finance income Consolidated Statements of Comprehensive Profit (Loss) (U.S. dollars in thousands) | Metric (U.S. dollars in thousands) | Q2 2025 (Unaudited) | Q2 2024 (Unaudited) | YoY Change | H1 2025 (Unaudited) | H1 2024 (Unaudited) | YoY Change | | :--------------------------------- | :------------------ | :------------------ | :--------- | :------------------ | :------------------ | :--------- | | Revenues | $12,632 | $10,005 | +26.3% | $24,168 | $19,100 | +26.5% | | Gross profit | $9,499 | $7,537 | +26.0% | $18,109 | $14,349 | +26.2% | | Operating profit | $578 | $586 | -1.4% | $1,154 | $679 | +69.9% | | Finance income | $2,303 | $518 | +344.6% | $3,414 | $1,115 | +206.2% | | Finance Expense | $784 | $401 | +95.5% | $1,207 | $808 | +49.4% | | Net profit and total comprehensive profit | $2,027 | $600 | +237.8% | $3,134 | $711 | +340.8% | | Basic net income per share | $0.05 | $0.02 | +150.0% | $0.08 | $0.02 | +300.0% | | Diluted net income per share | $0.05 | $0.02 | +150.0% | $0.07 | $0.02 | +250.0% | [Consolidated Statements of Cash Flows](index=6&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) In Q2 2025, net cash provided by operating activities significantly increased, while investing activities resulted in a net cash outflow due to purchases of financial assets and short-term deposits Consolidated Statements of Cash Flows (U.S. dollars in thousands) | Metric (U.S. dollars in thousands) | Q2 2025 (Unaudited) | Q2 2024 (Unaudited) | H1 2025 (Unaudited) | H1 2024 (Unaudited) | | :--------------------------------- | :------------------ | :------------------ | :------------------ | :------------------ | | Net cash provided by operating activities | $12,383 | $1,348 | $17,393 | $4,526 | | Net cash provided by (used in) investing activities | $(15,859) | $34,198 | $(17,825) | $33,488 | | Net cash used in financing activities | $(264) | $(35) | $(1,019) | $(624) | | Increase (decrease) in cash and cash equivalents | $(3,689) | $35,482 | $(1,433) | $37,344 | | Cash and cash equivalents at the end of the period | $67,912 | $47,864 | $67,912 | $47,864 | [Reconciliation of Adjusted EBITDA to Net Profit](index=8&type=section&id=Reconciliation%20of%20Adjusted%20EBITDA%20to%20Net%20Profit) The reconciliation shows that Adjusted EBITDA for Q2 2025 was $1.45 million, an increase from $1.25 million in Q2 2024, after adjusting net profit for non-cash and non-operating items Reconciliation of Adjusted EBITDA to Net Profit (U.S. dollars in thousands) | Metric (U.S. dollars in thousands) | Q2 2025 (Unaudited) | Q2 2024 (Unaudited) | H1 2025 (Unaudited) | H1 2024 (Unaudited) | | :--------------------------------- | :------------------ | :------------------ | :------------------ | :------------------ | | Net profit and total comprehensive profit | $2,027 | $600 | $3,134 | $711 | | Finance income, net | $(1,519) | $(117) | $(2,207) | $(307) | | Income taxes | $70 | $103 | $227 | $275 | | Depreciation and amortization | $180 | $58 | $371 | $120 | | Depreciation of leased systems | $208 | $240 | $411 | $495 | | Cost of share based payment | $227 | $364 | $552 | $669 | | Restructuring and litigation Cost | $258 | $0 | $258 | $0 | | **Adjusted EBITDA** | **$1,451** | **$1,248** | **$2,746** | **$1,963** |

Exhibit 99.1 Local Bounti Announces Second Quarter 2025 Financial Results Reports 28% Year-Over-Year Revenue Growth Driven by Expanded Facility Operations and Strengthened Retail Relationships Achieved $7 Million in Annualized Expense Reductions in the First Half of 2025 with Additional $2.5 to $3 Million of Cost Optimization Initiatives to be Actioned in the Second Half of 2025 Closed on $10 Million Convertible Note and Amended Credit Facility with $10 Million Principal Debt Reduction HAMILTON, MT – August ...

Executive Summary [Overall Highlights](index=1&type=section&id=Overall%20Highlights) BiomX reported significant clinical progress for BX211 and BX004 and anticipates multiple value-driving catalysts - Positive Phase 2 results for BX211 demonstrated **over 40% wound size reduction** versus placebo in diabetic foot osteomyelitis patients, with planning underway for a potential registrational study[1](index=1&type=chunk)[3](index=3&type=chunk) - New Phase 1b/2a data for BX004 showed **approximately 500-fold (2.7 log₁₀) bacterial reduction** versus placebo with no detectable emergence of resistance[1](index=1&type=chunk)[3](index=3&type=chunk) - The Phase 2b trial of BX004 in Cystic Fibrosis (CF) has successfully commenced patient dosing, with topline results expected in **Q1 2026**[1](index=1&type=chunk)[3](index=3&type=chunk) - BiomX is positioned for multiple value-driving catalysts over the next 12 months, including FDA feedback on BX004's real-world evidence strategy and planning for a potential registrational BX211 study[3](index=3&type=chunk) Clinical Program Updates [BX211 Program Update](index=1&type=section&id=BX211%20Program%20Update) Positive Phase 2 results for BX211 in diabetic foot infections showed significant improvements in wound healing - BX211 demonstrated a sustained and statistically significant percentage area reduction (PAR) of ulcer size with a difference **greater than 40%** by week 10 (p = 0.046 at week 12)[4](index=4&type=chunk)[12](index=12&type=chunk) - The Phase 2 trial also showed statistically significant improvements in ulcer depth (p=0.048) and in reducing the expansion of ulcer area (p=0.017) compared to placebo[6](index=6&type=chunk)[12](index=12&type=chunk) - Planning for a potential registrational study of BX211 is underway, pending feedback from the U.S. Food and Drug Administration (FDA) and availability of cash resources[6](index=6&type=chunk)[12](index=12&type=chunk) - The Company is in continued discussions with the U.S. Defense Health Agency regarding next steps for the BX211 program[6](index=6&type=chunk) [BX004 Program Update](index=2&type=section&id=BX004%20Program%20Update) Patient dosing has begun in the Phase 2b trial for BX004 in Cystic Fibrosis, with results expected in Q1 2026 - In July 2025, BiomX successfully initiated dosing of patients in its Phase 2b trial of BX004, a randomized, double-blind, placebo-controlled, multicenter study in approximately 60 CF patients[6](index=6&type=chunk) - Topline results from the Phase 2b study are expected in the **first quarter of 2026**[6](index=6&type=chunk) - BiomX expects to receive feedback from the FDA in the **second half of 2025** regarding the potential investigation and use of real-world evidence linking bacterial reduction to clinical outcomes[6](index=6&type=chunk) - New findings from the Phase 1b/2a trial showed BX004 achieved **approximately 500-fold (2.7 log₁₀) greater bacterial reduction** compared with placebo, with no bacterial resistance detected[6](index=6&type=chunk) Second Quarter 2025 Financial Results [Cash Position](index=3&type=section&id=Cash%20Position) Cash and restricted cash decreased to $15.2 million, sufficient to fund operations into Q1 2026 Cash and Restricted Cash | Metric | June 30, 2025 (USD in millions) | December 31, 2024 (USD in millions) | | :--- | :--- | :--- | | Cash and restricted cash | 15.2 | 18.0 | - The decrease in cash was primarily due to net cash used in operating activities[7](index=7&type=chunk) - BiomX estimates its cash, cash equivalents and restricted cash are sufficient to fund its operations into the **first quarter of 2026**[7](index=7&type=chunk) [Operating Expenses](index=3&type=section&id=Operating%20Expenses) Operating expenses decreased year-over-year due to workforce reductions and lower professional fees Operating Expenses (Q2 2025 vs. Q2 2024) | Expense Category | Q2 2025 (USD in thousands) | Q2 2024 (USD in thousands) | Change (YoY) | | :--- | :--- | :--- | :--- | | Research and development | 5,014 | 6,897 | -27.3% | | General and administrative | 2,419 | 2,828 | -14.4% | - The decrease in R&D expenses was primarily driven by reduced salary expenses from workforce reductions, lower rent expenses, and increased grant funding, partially offset by higher expenses from initiating the Phase 2b clinical trial of BX004[8](index=8&type=chunk) - The decrease in G&A expenses was primarily attributed to a reduction in legal and other professional service fees, partially offset by increased share-based compensation expenses[9](index=9&type=chunk) [Net Loss and Cash Flow](index=3&type=section&id=Net%20Loss%20and%20Cash%20Flow) The company reported a net loss of $6.0 million for Q2 2025, with a year-over-year decrease in cash used for operations Net Loss and Operating Cash Flow | Metric | Q2 2025 (USD in thousands) | Q2 2024 (USD in thousands) | 6 Months 2025 (USD in thousands) | 6 Months 2024 (USD in thousands) | | :--- | :--- | :--- | :--- | :--- | | Net loss (income) | 6,037 | (4,471) | 13,696 | 12,856 | | Net cash used in operating activities | N/A | N/A | 14,800 | 22,600 | - The net loss for Q2 2025 was mainly due to the change in the fair value of warrants issued as part of the Company's March 2024 financing[10](index=10&type=chunk) - Net cash used in operating activities for the six months ended June 30, 2025, **decreased to $14.8 million** from $22.6 million for the same period in 2024[10](index=10&type=chunk) Company Information & Forward-Looking Statements [Conference Call and Webcast Details](index=3&type=section&id=Conference%20Call%20and%20Webcast%20Details) BiomX hosted a conference call to discuss its Q2 2025 financial results and provide a corporate update - A conference call and webcast were held on August 13, 2025, at 8 AM ET[11](index=11&type=chunk) - Links for registration and webcast replay were provided[12](index=12&type=chunk) [About BX211 (Program Overview)](index=3&type=section&id=About%20BX211%20(Program%20Overview)) BX211 is a phage treatment targeting S. aureus in diabetic foot osteomyelitis, a leading cause of amputation - BX211 is a phage treatment for DFO associated with S. aureus, a bacterial infection of the bone that often leads to amputation in diabetic patients[12](index=12&type=chunk) - Positive Phase 2 results showed BX211 was safe and well-tolerated, producing statistically significant and sustained reduction of ulcer size (PAR) and improvements in ulcer depth[12](index=12&type=chunk) [About BX004 (Program Overview)](index=4&type=section&id=About%20BX004%20(Program%20Overview)) BX004 is a multi-phage cocktail for treating chronic P. aeruginosa infections in Cystic Fibrosis patients - BX004 is a fixed multi-phage cocktail for the treatment of CF patients with chronic pulmonary infections caused by P. aeruginosa, a major contributor to morbidity and mortality[13](index=13&type=chunk) - Positive results from Phase 1b/2a studies demonstrated safety, tolerability, microbiologic activity, and improvement in pulmonary function associated with a reduction in P. aeruginosa burden in a predefined subgroup[13](index=13&type=chunk) - BX004 has received **FDA Fast Track and Orphan Drug Designations**[13](index=13&type=chunk) [About BiomX (Company Overview)](index=4&type=section&id=About%20BiomX%20(Company%20Overview)) BiomX is a clinical-stage company developing phage treatments to destroy harmful bacteria in chronic diseases - BiomX is a clinical-stage company developing natural and engineered phage cocktails and personalized phage treatments[14](index=14&type=chunk) - The company aims to target and destroy harmful bacteria for the treatment of chronic diseases with substantial unmet needs, using its BOLT ("BacteriOphage Lead to Treatment") platform[14](index=14&type=chunk) [Safe Harbor Statement](index=4&type=section&id=Safe%20Harbor%20Statement) This section disclaims forward-looking statements, highlighting inherent risks and uncertainties - The press release contains forward-looking statements subject to inherent uncertainties, risks, and changes in circumstances, including adverse results in clinical development, regulatory decisions, and the sufficiency of cash resources[15](index=15&type=chunk) - Investors should not rely on these statements and are advised to review risks and uncertainties detailed in BiomX's SEC filings, particularly the Annual Report on Form 10-K[15](index=15&type=chunk) Financial Statements [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheets show the company's financial position as of June 30, 2025, compared to December 31, 2024 Condensed Consolidated Balance Sheets (USD in thousands) | ASSETS / LIABILITIES AND STOCKHOLDERS' EQUITY | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **ASSETS** | | | | Current assets | 16,635 | 20,520 | | Total non-current assets | 21,415 | 22,713 | | **Total Assets** | **38,050** | **43,233** | | **LIABILITIES** | | | | Current liabilities | 6,262 | 8,267 | | Total non-current liabilities | 12,628 | 10,818 | | **Total Liabilities** | **18,890** | **19,085** | | **STOCKHOLDERS' EQUITY** | | | | Total stockholders' equity | 19,160 | 24,148 | | **Total Liabilities and Stockholders' Equity**| **38,050** | **43,233** | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statements of operations detail financial performance for the three and six months ended June 30, 2025 Condensed Consolidated Statements of Operations (USD in thousands, except per share data) | 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 | | :--- | :--- | :--- | :--- | :--- | | Research and development ("R&D") expenses, net | 5,014 | 6,897 | 10,264 | 11,002 | | General and administrative expenses | 2,419 | 2,828 | 4,925 | 5,508 | | Operating loss | 7,433 | 9,725 | 15,189 | 16,510 | | Net loss (income) | 6,037 | (4,471) | 13,696 | 12,856 | | Basic loss (earnings) per share of Common Stock | 0.19 | (0.14) | 0.50 | 1.95 | | Diluted loss per share of Common Stock | 0.19 | 0.69 | 0.50 | 1.95 |

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section covers unaudited financial statements, management's discussion, market risk, and internal controls [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for Aura Biosciences, Inc. for the quarterly period ended June 30, 2025, reflecting increased cash from financing and widening net losses [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2025, shows total assets of $204.4 million, driven by a rise in cash to $107.4 million from a follow-on offering, with total liabilities slightly decreasing and stockholders' equity increasing Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $107,367 | $31,693 | | Total Assets | $204,397 | $182,503 | | Total Liabilities | $29,768 | $30,533 | | Total Stockholders' Equity | $174,629 | $151,970 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended June 30, 2025, the company reported a net loss of $27.0 million, primarily due to higher research and development expenses, with the six-month net loss widening to $54.5 million Statement of Operations Summary (in thousands, except per share data) | 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 and development | $22,882 | $16,879 | $46,225 | $33,932 | | General and administrative | $5,731 | $5,883 | $11,423 | $11,145 | | Total operating loss | $(28,613) | $(22,762) | $(57,648) | $(45,077) | | Net loss | $(27,019) | $(20,337) | $(54,502) | $(40,043) | | Net loss per share | $(0.47) | $(0.41) | $(1.01) | $(0.81) | [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Total stockholders' equity increased to $174.6 million by June 30, 2025, primarily driven by $46.5 million in net proceeds from a follow-on offering, partially offset by a $54.5 million net loss - The company completed a follow-on offering, issuing **11,735,565 shares of common stock** and various warrants, resulting in net proceeds of approximately **$69.9 million** after costs[17](index=17&type=chunk)[44](index=44&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities was $44.1 million, while investing activities provided $49.8 million and financing activities provided $70.0 million, leading to a net cash increase of $75.7 million Six-Month Cash Flow Summary (in thousands) | Metric | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(44,129) | $(40,580) | | Net cash provided by investing activities | $49,790 | $29,237 | | Net cash provided by financing activities | $70,025 | $336 | | Net increase (decrease) in cash | $75,686 | $(11,007) | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's focus on its lead candidate, bel-sar, its reliance on capital raises, the May 2025 follow-on offering, and management's assertion of sufficient funding for the next 12 months - Aura Biosciences is a clinical-stage biotechnology company focused on developing its lead candidate, **bel-sar**, a Virus-Like Drug Conjugate (VDC), for the treatment of solid tumors, with an initial focus on ocular and urologic oncology[23](index=23&type=chunk) - In May 2025, the company completed a follow-on offering, receiving approximately **$69.9 million** in net proceeds after deducting underwriting discounts and commissions[26](index=26&type=chunk)[44](index=44&type=chunk) - The company expects its cash, cash equivalents, and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements through at least **12 months** from the issuance of these financial statements[27](index=27&type=chunk) - As of June 30, 2025, there was **$16.7 million** of unrecognized compensation expense related to stock options and **$19.5 million** related to unvested restricted stock units, expected to be recognized over weighted-average periods of **2.89 and 3.07 years**, respectively[57](index=57&type=chunk)[58](index=58&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance and operational progress, highlighting increased R&D expenses for the bel-sar Phase 3 trial, a $54.5 million net loss, and $177.3 million in cash and marketable securities expected to fund operations into the first half of 2027 - The company's lead candidate, **bel-sar**, is in an ongoing global Phase 3 CoMpass trial for the first-line treatment of early choroidal melanoma, with enrollment potentially completing as early as the end of **2025**[93](index=93&type=chunk) - **Bel-sar** is also being developed for other indications, including a Phase 2 trial for metastases to the choroid and a Phase 1b/2 trial for non-muscle invasive bladder cancer (NMIBC)[95](index=95&type=chunk)[98](index=98&type=chunk) Comparison of Operating Results (Six Months Ended June 30, in thousands) | Metric | 2025 (in thousands) | 2024 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | Research and development | $46,225 | $33,932 | $12,293 | | General and administrative | $11,423 | $11,145 | $278 | | Total operating expenses | $57,648 | $45,077 | $12,571 | | Net loss | $(54,502) | $(40,043) | $(14,459) | - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities of **$177.3 million**, which management believes will fund operations into the **first half of 2027**[105](index=105&type=chunk)[129](index=129&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company, as a smaller reporting entity, is not required to provide quantitative and qualitative disclosures regarding market risk - As a smaller reporting company, Aura Biosciences is not required to provide quantitative and qualitative disclosures about market risk[143](index=143&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[145](index=145&type=chunk) - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[146](index=146&type=chunk) [PART II. OTHER INFORMATION](index=35&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section outlines legal proceedings, risk factors, equity sales, and other required disclosures [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) As of June 30, 2025, the company is not involved in any legal proceedings that would reasonably be expected to have a material adverse effect on its business - As of June 30, 2025, the company is not involved in any material legal proceedings[148](index=148&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) This section provides a comprehensive overview of material risks, including a history of significant net losses, heavy dependence on its sole product candidate bel-sar, the need for substantial additional capital, and complexities in regulatory approval and commercialization - The company has incurred significant net losses since inception, with an accumulated deficit of **$428.7 million** as of June 30, 2025, and anticipates continued losses for the foreseeable future[150](index=150&type=chunk) - The company's business is heavily dependent on the successful development, regulatory approval, and commercialization of its only product candidate, **bel-sar**[164](index=164&type=chunk) - Substantial additional capital will be required to finance operations. The company's existing cash is expected to fund operations into the **first half of 2027**, but it will not be sufficient to fund **bel-sar** through regulatory approval[154](index=154&type=chunk)[155](index=155&type=chunk) - The company relies on third parties, such as CROs and CDMOs, to conduct clinical trials and manufacture **bel-sar**, which increases risks related to performance, compliance, and supply chain disruptions[219](index=219&type=chunk)[223](index=223&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=87&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities occurred during the reporting period - There were no unregistered sales of equity securities during the quarter[364](index=364&type=chunk) [Item 3. Defaults Upon Senior Securities](index=87&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company - Not applicable[367](index=367&type=chunk) [Item 4. Mine Safety Disclosures](index=87&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[368](index=368&type=chunk) [Item 5. Other Information](index=87&type=section&id=Item%205.%20Other%20Information) The company discloses that no directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025 - No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement during the quarter[369](index=369&type=chunk) [Item 6. Exhibits](index=88&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate governance documents, warrant forms, compensation policies, and required certifications - The report includes a list of filed exhibits, such as corporate governance documents, warrant forms, and required CEO/CFO certifications[370](index=370&type=chunk)

[Executive Summary](index=1&type=section&id=Executive%20Summary) Tourmaline Bio reported Q2 2025 financial results and positive Phase 2 TRANQUILITY trial data for pacibekitug, demonstrating rapid, deep, and durable hs-CRP reductions with quarterly dosing [Second Quarter 2025 Overview](index=1&type=section&id=Second%20Quarter%202025%20Overview) Tourmaline Bio reported its Q2 2025 financial results and highlighted positive topline data from the Phase 2 TRANQUILITY trial of pacibekitug, demonstrating rapid, deep, and durable reductions in hs-CRP with quarterly dosing - Tourmaline Bio reported positive topline results from the ongoing Phase 2 TRANQUILITY trial of pacibekitug in May 2025, showing rapid, deep, and durable reductions in high-sensitivity C-reactive protein (hs-CRP) with quarterly dosing[1](index=1&type=chunk) - The CEO, Sandeep Kulkarni, stated that the second quarter of 2025 was a 'transformative period' due to the first data readout for pacibekitug, which demonstrated the viability of quarterly subcutaneous administration and unlocked its best-in-class potential[2](index=2&type=chunk) [Recent Business Highlights](index=1&type=section&id=Recent%20Business%20Highlights) Tourmaline Bio announced positive Phase 2 TRANQUILITY trial results for pacibekitug in cardiovascular inflammation and continues development for AAA and ASCVD, while the TED trial progresses [Cardiovascular Inflammation Highlights](index=1&type=section&id=Cardiovascular%20Inflammation%20Highlights) Tourmaline Bio announced positive topline results from the Phase 2 TRANQUILITY trial for pacibekitug, showing significant hs-CRP reductions with quarterly dosing, and is progressing with Phase 2 AAA and Phase 3 ASCVD trials [TRANQUILITY Topline Results](index=1&type=section&id=TRANQUILITY%20Topline%20Results) - Positive topline results from the Phase 2 TRANQUILITY trial were announced on May 20, 2025, evaluating quarterly and monthly subcutaneous dosing of pacibekitug in patients with elevated hs-CRP and chronic kidney disease[5](index=5&type=chunk) - Rapid, deep, and durable reductions in hs-CRP through Day 90 were achieved across all pacibekitug arms with high statistical significance (**p<0.0001**) compared to placebo[5](index=5&type=chunk) - Pacibekitug is the first and only IL-6 inhibitor known to demonstrate deep hs-CRP reductions with quarterly dosing, achieving **>85% hs-CRP reductions** from baseline in the 50 mg quarterly arm after a single dose[5](index=5&type=chunk) - The overall incidence rates of adverse events and serious adverse events in the pacibekitug groups were comparable to placebo through April 23, 2025[5](index=5&type=chunk)[6](index=6&type=chunk) [Ongoing Development Activities](index=2&type=section&id=Ongoing%20Development%20Activities) - Tourmaline continues to plan for a Phase 3 cardiovascular outcomes trial in atherosclerotic cardiovascular disease (ASCVD)[4](index=4&type=chunk)[11](index=11&type=chunk) - The company completed a successful pre-IND interaction with the FDA and is on track to initiate a Phase 2 proof-of-concept trial in abdominal aortic aneurysm (AAA) in the second half of 2025[4](index=4&type=chunk)[11](index=11&type=chunk) [Presentations and Publications](index=2&type=section&id=Presentations%20and%20Publications) - Additional data from the TRANQUILITY trial will be presented at the European Society of Cardiology (ESC) Congress on August 31, 2025[4](index=4&type=chunk)[11](index=11&type=chunk) - Tourmaline's SVP of Medical Research and VP, Head of Medical Affairs, were contributing authors on a review manuscript entitled 'Human Genetics Informing Drug Development in Cardiovascular Disease: Interleukin-6 Signaling as a Case Study' published in August 2025[11](index=11&type=chunk) [Thyroid Eye Disease (TED) Highlights](index=2&type=section&id=Thyroid%20Eye%20Disease%20%28TED%29%20Highlights) The Phase 2b spiriTED trial for pacibekitug in Thyroid Eye Disease (TED) is ongoing, with topline data expected in early 2026 - The Phase 2b spiriTED trial for TED remains ongoing[11](index=11&type=chunk) - Topline data from the spiriTED trial is expected in early 2026[11](index=11&type=chunk) - Tourmaline expects to provide additional information on future development plans in TED after reviewing spiriTED trial data[11](index=11&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Tourmaline Bio reported a net loss of **$23.1 million** for Q2 2025, driven by increased operating expenses, and maintains a cash runway into the second half of 2027 [Financial Overview](index=2&type=section&id=Financial%20Overview) Tourmaline Bio reported a net loss of **$23.1 million** for Q2 2025, an increase from Q2 2024, primarily due to higher operating expenses driven by increased clinical trial activities and headcount [Cash Position](index=2&type=section&id=Cash%20Position) Cash, Cash Equivalents, and Investments | Metric | June 30, 2025 (Millions USD) | December 31, 2024 (Millions USD) | | :-------------------------------- | :-------------------------- | :------------------------------ | | Cash, cash equivalents, and investments | $256.4 | $294.9 | - Current cash, cash equivalents, and investments are anticipated to provide a cash runway into the second half of 2027, funding operations through key pacibekitug data readouts and development activities[4](index=4&type=chunk)[10](index=10&type=chunk)[12](index=12&type=chunk) [Operating Expenses](index=3&type=section&id=Operating%20Expenses) Operating Expenses (Q2 2025 vs Q2 2024) | Expense Category | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | YoY Change (Millions USD) | YoY Change (%) | | :------------------------ | :-------------------- | :-------------------- | :-------------------- | :------------- | | Research and development | $19.6 | $15.7 | +$3.9 | +24.8% | | General and administrative | $6.3 | $6.2 | +$0.1 | +1.6% | | **Total operating expenses** | **$26.0** | **$22.0** | **+$4.0** | **+18.2%** | - The increase in R&D expenses was primarily driven by increased clinical trial expenses (TRANQUILITY and spiriTED), routine toxicology study expenses, additional headcount, and consulting expenses, partially offset by decreased chemistry, manufacturing, and controls expenses[17](index=17&type=chunk) [Net Loss](index=3&type=section&id=Net%20Loss) Net Loss (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | YoY Change (Millions USD) | YoY Change (%) | | :------------------------ | :-------------------- | :-------------------- | :-------------------- | :------------- | | Net loss | $(23.1) | $(17.5) | $(5.6) | +32.0% | | Net loss per share, basic and diluted | $(0.90) | $(0.68) | $(0.22) | +32.4% | - The increase in both net loss and net loss per share was attributable to increased operating expenses and Tourmaline's overall growth from 2024 to 2025[17](index=17&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The condensed consolidated statements of operations show a net loss of **$23.092 million** for the three months ended June 30, 2025, and **$46.062 million** for the six months ended June 30, 2025, reflecting increased operating expenses year-over-year Condensed Consolidated Statements of Operations (Unaudited) | | Three Months Ended June 30, | | Six Months Ended June 30, | | | :------------------------------------------ | :---------- | :---------- | :---------- | :---------- | | | **2025 (Thousands USD)** | **2024 (Thousands USD)** | **2025 (Thousands USD)** | **2024 (Thousands USD)** | | Operating expenses: | | | | | | Research and development | $19,634 | $15,734 | $39,892 | $27,110 | | General and administrative | 6,340 | 6,237 | 12,313 | 12,378 | | Total operating expenses | 25,974 | 21,971 | 52,205 | 39,488 | | Loss from operations | (25,974) | (21,971) | (52,205) | (39,488) | | Other income, net | 2,882 | 4,484 | 6,143 | 8,690 | | **Net loss** | **$(23,092)** | **$(17,487)** | **$(46,062)** | **$(30,798)** | | Net loss per share, basic and diluted | $(0.90) | $(0.68) | $(1.79) | $(1.24) | | Weighted-average common shares outstanding, basic and diluted | 25,755 | 25,724 | 25,723 | 24,908 | [Selected Condensed Consolidated Balance Sheet Data](index=5&type=section&id=Selected%20Condensed%20Consolidated%20Balance%20Sheet%20Data) As of June 30, 2025, Tourmaline Bio reported cash, cash equivalents, and investments of **$256.4 million**, a decrease from December 31, 2024 Selected Condensed Consolidated Balance Sheet Data (Unaudited) | | June 30, 2025 (Thousands USD) | December 31, 2024 (Thousands USD) | | :------------------------------ | :-------------------------- | :------------------------------ | | Cash, cash equivalents and investments | $256,418 | $294,936 | | Working capital | $239,006 | $259,933 | | Total assets | $269,295 | $309,001 | | Total stockholders' equity | $259,192 | $300,052 | [Company Information](index=3&type=section&id=Company%20Information) Tourmaline Bio is a late-stage clinical biotechnology company focused on developing transformative medicines for immune and inflammatory diseases, with pacibekitug as its lead asset [About Tourmaline Bio](index=3&type=section&id=About%20Tourmaline%20Bio) Tourmaline Bio is a late-stage clinical biotechnology company focused on developing transformative medicines for immune and inflammatory diseases, with pacibekitug as its lead asset - Tourmaline Bio is a late-stage clinical biotechnology company developing transformative medicines for life-altering immune and inflammatory diseases[14](index=14&type=chunk) - Pacibekitug is Tourmaline's lead asset[14](index=14&type=chunk) [About Pacibekitug](index=3&type=section&id=About%20Pacibekitug) Pacibekitug is a long-acting, fully-human, anti-IL-6 monoclonal antibody with best-in-class potential, currently being developed for ASCVD and TED, with plans to expand into AAA and other indications - Pacibekitug is a long-acting, fully-human, anti-IL-6 monoclonal antibody with best-in-class potential, featuring a naturally long half-life, low immunogenicity, and high binding affinity to IL-6[15](index=15&type=chunk) - Excluding ongoing trials, pacibekitug was previously studied in approximately **450 participants** across six completed clinical trials for autoimmune disorders[15](index=15&type=chunk) - Tourmaline is currently developing pacibekitug for atherosclerotic cardiovascular disease (ASCVD) and thyroid eye disease (TED) as its first two indications, with plans to expand into abdominal aortic aneurysm (AAA) and additional diseases[15](index=15&type=chunk) [Legal and Contact Information](index=3&type=section&id=Legal%20and%20Contact%20Information) This section provides cautionary notes regarding forward-looking statements, outlining inherent risks and uncertainties, and lists contact information for media and investors [Cautionary Note Regarding Forward-Looking Statements](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This section outlines that statements not describing historical facts are forward-looking and involve risks and uncertainties that could cause actual results to differ materially - Statements in the press release that do not describe historical facts are forward-looking statements, identified by words like 'believe,' 'expect,' 'may,' 'plan,' 'potential,' and 'will'[16](index=16&type=chunk) - These statements involve risks and uncertainties that could cause actual results to differ materially, including risks related to product development, clinical trial delays, replication of prior results, safety/efficacy profiles, financial estimates, competition, regulatory environment, and macroeconomic conditions[18](index=18&type=chunk) - Tourmaline assumes no obligation to update any forward-looking statements[18](index=18&type=chunk) [Contacts](index=6&type=section&id=Contacts) Contact information for media and investor relations is provided - Media Contact: Scient PR, Sarah Mishek (SMishek@ScientPR.com)[21](index=21&type=chunk) - Investor Contact: Meru Advisors, Lee M. Stern (lstern@meruadvisors.com)[21](index=21&type=chunk)

[Company Overview and Q2 2025 Highlights](index=1&type=section&id=Company%20Overview%20and%20Q2%202025%20Highlights) The company reported positive Phase 2 trial results for pacibekitug and outlined its future clinical development strategy [Q2 2025 Business Highlights](index=1&type=section&id=Q2%202025%20Business%20Highlights) The company announced positive Phase 2 trial results for pacibekitug and provided an update on its cash runway - Positive topline results from the Phase 2 TRANQUILITY trial of pacibekitug showed **rapid, deep, and durable reductions in high-sensitivity C-reactive protein (hs-CRP)** with quarterly dosing[1](index=1&type=chunk) - Additional data from the TRANQUILITY trial will be presented at the European Society of Cardiology Congress in August 2025[1](index=1&type=chunk) - The company is on track to initiate a Phase 2 proof-of-concept trial in abdominal aortic aneurysm (AAA) in the second half of 2025[4](index=4&type=chunk) - Planning is underway for a Phase 3 cardiovascular outcomes trial in atherosclerotic cardiovascular disease (ASCVD)[4](index=4&type=chunk) Cash Position as of June 30, 2025 | Metric | Amount (Millions USD) | | :----- | :-------------------- | | Cash, cash equivalents, and investments | $256.4 | | Expected cash runway | Into H2 2027 | [CEO Commentary](index=1&type=section&id=CEO%20Commentary) The CEO highlighted pacibekitug's best-in-class potential following positive Phase 2 data and outlined plans for further development - Q2 2025 was a transformative period for Tourmaline with the first data readout for pacibekitug[2](index=2&type=chunk) - Topline results from the Phase 2 TRANQUILITY trial unlocked **pacibekitug's best-in-class potential** by demonstrating the viability of quarterly subcutaneous administration[2](index=2&type=chunk) - The company plans to advance pacibekitug into the next stage of development within cardiovascular inflammation, including a planned Phase 2 trial in AAA in H2 2025[2](index=2&type=chunk) [Clinical Development Updates](index=1&type=section&id=Clinical%20Development%20Updates) The company provided updates on its cardiovascular inflammation and Thyroid Eye Disease programs for pacibekitug [Cardiovascular Inflammation Program](index=1&type=section&id=Cardiovascular%20Inflammation%20Highlights) The pacibekitug program advanced with positive Phase 2 results and plans for Phase 3 trials in cardiovascular diseases [TRANQUILITY Phase 2 Trial Topline Results](index=1&type=section&id=TRANQUILITY%20Topline%20Results) The Phase 2 trial demonstrated statistically significant hs-CRP reductions with quarterly dosing and a favorable safety profile - Positive topline results from the ongoing Phase 2 TRANQUILITY trial were announced on May 20, 2025[5](index=5&type=chunk) - **Rapid, deep, and durable reductions in hs-CRP** through Day 90 were achieved across all pacibekitug arms with high statistical significance (p<0.0001) compared to placebo[5](index=5&type=chunk) - Pacibekitug is the **first and only IL-6 inhibitor known to demonstrate deep hs-CRP reductions with quarterly dosing** in a clinical trial, achieving >85% reduction from baseline[5](index=5&type=chunk) - The overall incidence rates of adverse events were comparable to placebo[5](index=5&type=chunk)[6](index=6&type=chunk) [Ongoing Development Activities](index=2&type=section&id=Ongoing%20Development%20Activities) The company is progressing with plans for a Phase 3 ASCVD trial and a Phase 2 AAA trial for pacibekitug - The TRANQUILITY trial serves as the starting point for pacibekitug's clinical development program for ASCVD and other inflammation-driven cardiovascular diseases[11](index=11&type=chunk) - Planning for a **Phase 3 cardiovascular outcomes trial in ASCVD** is progressing[11](index=11&type=chunk) - A successful pre-IND interaction with the FDA was completed for a Phase 2 proof-of-concept trial in AAA, with initiation on track for H2 2025[11](index=11&type=chunk) [Presentations and Publications](index=2&type=section&id=Presentations%20and%20Publications) Additional trial data will be presented at an upcoming cardiology congress, and the company contributed to a relevant publication - Additional data from the TRANQUILITY trial will be presented at the **European Society of Cardiology (ESC) Congress** on August 31, 2025[11](index=11&type=chunk) - Company representatives co-authored a review manuscript on IL-6 signaling in cardiovascular disease published in *Circulation: Genomic and Precision Medicine*[11](index=11&type=chunk) [Thyroid Eye Disease (TED) Program](index=2&type=section&id=Thyroid%20Eye%20Disease%20%28TED%29%20Highlights) The Phase 2b spiriTED trial is ongoing with topline data expected in early 2026 - The Phase 2b spiriTED trial for pacibekitug in TED remains ongoing[11](index=11&type=chunk) - **Topline data from the spiriTED trial is expected in early 2026**[11](index=11&type=chunk) - Tourmaline presented a poster on the prevalence of TED in the United States at the ARVO Annual Conference in May 2025[11](index=11&type=chunk) - Future development plans in TED will be determined after a review of the Phase 2b spiriTED trial data[11](index=11&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reported a higher net loss driven by increased operating expenses, while maintaining a cash runway into H2 2027 [Cash Position and Runway](index=2&type=section&id=Cash%20Position) Cash and investments totaled $256.4 million, providing a projected operational runway into the second half of 2027 Cash, Cash Equivalents, and Investments | Metric | June 30, 2025 (Millions USD) | December 31, 2024 (Millions USD) | Change (Millions USD) | | :----- | :--------------------------- | :------------------------------- | :-------------------- | | Cash, cash equivalents, and investments | $256.4 | $294.9 | -$38.5 | - Current cash, cash equivalents, and investments are anticipated to provide a **cash runway into the second half of 2027**[10](index=10&type=chunk)[12](index=12&type=chunk) [Operating Expenses](index=3&type=section&id=Operating%20Expenses) Total operating expenses rose to $26.0 million, primarily due to increased research and development activities Operating Expenses (Three Months Ended June 30) | Expense Category | Q2 2025 (Thousands USD) | Q2 2024 (Thousands USD) | YoY Change (Thousands USD) | YoY Change (%) | | :--------------- | :---------------------- | :---------------------- | :------------------------- | :------------- | | Research and development | $19,634 | $15,734 | $3,900 | 24.8% | | General and administrative | $6,340 | $6,237 | $103 | 1.6% | | **Total operating expenses** | **$25,974** | **$21,971** | **$4,003** | **18.2%** | - The increase in research and development expenses was primarily driven by **increased clinical trial expenses** and employee compensation costs[17](index=17&type=chunk) - The slight increase in general and administrative expenses was primarily driven by increased employee compensation costs[17](index=17&type=chunk) [Net Loss](index=3&type=section&id=Net%20Loss) The net loss for the quarter increased to $23.1 million, or $0.90 per share, reflecting higher operational spending Net Loss (Three Months Ended June 30) | Metric | Q2 2025 (Thousands USD) | Q2 2024 (Thousands USD) | YoY Change (Thousands USD) | YoY Change (%) | | :----- | :---------------------- | :---------------------- | :------------------------- | :------------- | | Net loss | $(23,092)$ | $(17,487)$ | $(5,605)$ | 32.0% | | Net loss per share, basic and diluted | $(0.90)$ | $(0.68)$ | $(0.22)$ | 32.4% | - The increase in net loss was attributable to **increased operating expenses** and the company's overall growth[17](index=17&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20%28unaudited%29) The statement details a Q2 2025 net loss of $23.1 million, an increase from $17.5 million in the prior-year period Condensed Consolidated Statements of Operations (Unaudited) | | Three Months Ended June 30, | | Six Months Ended June 30, | | :---------------------------------- | :---------- | :---------- | :---------- | :---------- | | **(amounts in thousands)** | **2025** | **2024** | **2025** | **2024** | | Research and development | $19,634 | $15,734 | $39,892 | $27,110 | | General and administrative | $6,340 | $6,237 | $12,313 | $12,378 | | Total operating expenses | $25,974 | $21,971 | $52,205 | $39,488 | | Loss from operations | $(25,974)$ | $(21,971)$ | $(52,205)$ | $(39,488)$ | | Other income, net | $2,882 | $4,484 | $6,143 | $8,690 | | **Net loss** | **$(23,092)$** | **$(17,487)$** | **$(46,062)$** | **$(30,798)$** | | Net loss per share, basic and diluted | $(0.90)$ | $(0.68)$ | $(1.79)$ | $(1.24)$ | | Weighted-average common shares outstanding, basic and diluted | 25,755 | 25,724 | 25,723 | 24,908 | [Selected Condensed Consolidated Balance Sheet Data](index=5&type=section&id=Selected%20Condensed%20Consolidated%20Balance%20Sheet%20Data%20%28unaudited%29) The balance sheet shows cash and investments of $256.4 million and total assets of $269.3 million as of June 30, 2025 Selected Condensed Consolidated Balance Sheet Data (Unaudited) | | June 30, 2025 (Thousands USD) | December 31, 2024 (Thousands USD) | | :------------------------------ | :------------------------------ | :-------------------------------- | | Cash, cash equivalents and investments | $256,418 | $294,936 | | Working capital | $239,006 | $259,933 | | Total assets | $269,295 | $309,001 | | Total stockholders' equity | $259,192 | $300,052 | [Company and Product Information](index=3&type=section&id=Company%20and%20Product%20Information) This section provides an overview of Tourmaline Bio's mission and its lead asset, pacibekitug [About Tourmaline Bio](index=3&type=section&id=About%20Tourmaline%20Bio) Tourmaline Bio is a late-stage clinical biotechnology company developing medicines for immune and inflammatory diseases - Tourmaline is a **late-stage clinical biotechnology company**[14](index=14&type=chunk) - Its mission is to develop transformative medicines for patients with life-altering immune and inflammatory diseases[14](index=14&type=chunk) - **Pacibekitug** is Tourmaline's lead asset[14](index=14&type=chunk) [About Pacibekitug](index=3&type=section&id=About%20Pacibekitug) Pacibekitug is a long-acting, anti-IL-6 monoclonal antibody being developed for cardiovascular and thyroid eye diseases - Pacibekitug is a long-acting, fully-human, anti-IL-6 monoclonal antibody with **best-in-class potential**[15](index=15&type=chunk) - Differentiated properties include a **naturally long half-life**, low immunogenicity, and high binding affinity to IL-6[15](index=15&type=chunk) - The product has been studied in approximately 450 participants across six completed clinical trials[15](index=15&type=chunk) - Pacibekitug is currently being developed for **atherosclerotic cardiovascular disease (ASCVD) and thyroid eye disease (TED)**, with plans to expand into other diseases[15](index=15&type=chunk) [Legal and Contact Information](index=3&type=section&id=Legal%20and%20Contact%20Information) This section contains the forward-looking statements disclaimer and contact details for inquiries [Cautionary Note Regarding Forward-Looking Statements](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This note outlines the risks and uncertainties associated with forward-looking statements in the report - Statements in this press release that do not describe historical facts may constitute forward-looking statements[16](index=16&type=chunk) - These statements involve risks and uncertainties that could cause actual results to differ materially from projections[18](index=18&type=chunk) - Risks include those inherent in therapeutic product development, clinical trial delays, and changes in the regulatory environment[18](index=18&type=chunk) - Tourmaline assumes no obligation to update any forward-looking statements[18](index=18&type=chunk) [Contacts](index=6&type=section&id=Contacts) This section provides contact information for media and investor relations - Media Contact: Sarah Mishek at Scient PR (SMishek@ScientPR.com)[21](index=21&type=chunk) - Investor Contact: Lee M. Stern at Meru Advisors (lstern@meruadvisors.com)[21](index=21&type=chunk)

[Business Update and Q2 2025 Financial Results](index=1&type=section&id=Mersana%20Therapeutics%20Provides%20Business%20Update%20and%20Announces%20Second%20Quarter%202025%20Financial%20Results) Mersana Therapeutics provided a comprehensive business update, highlighting clinical progress for Emi-Le and XMT-2056, corporate actions like a reverse stock split, and detailed Q2 2025 financial performance [Business and Pipeline Update](index=1&type=section&id=Business%20and%20Pipeline%20Update) Mersana Therapeutics reported encouraging clinical data for its lead ADC, Emi-Le, and advanced its Phase 1 dose expansion, while XMT-2056 progressed and a $15 million GSK milestone was achieved [Emiltatug Ledadotin (Emi-Le; XMT-1660)](index=1&type=section&id=Emiltatug%20Ledadotin%20(Emi-Le%3B%20XMT-1660)) The company presented positive clinical data for Emi-Le, its B7-H4-directed ADC, at ASCO 2025 and ESMO Breast Cancer 2025, highlighting its activity in patients with TNBC and ACC-1, with initial data from the Phase 1 dose expansion trial anticipated in the second half of 2025 - Encouraging clinical data for Emi-Le was presented in oral sessions at both ASCO 2025 and ESMO Breast Cancer 2025, showing activity in patients with post-topo-1 TNBC and adenoid cystic carcinoma type 1 (ACC-1)[3](index=3&type=chunk)[5](index=5&type=chunk) - The Phase 1 dose expansion has enrolled over **45 patients** with TNBC across two cohorts[6](index=6&type=chunk)[7](index=7&type=chunk)[8](index=8&type=chunk) - Mersana plans to report initial clinical data from these expansion cohorts in the **second half of 2025**[3](index=3&type=chunk)[6](index=6&type=chunk)[8](index=8&type=chunk) [XMT-2056](index=2&type=section&id=XMT-2056) The Phase 1 dose escalation for XMT-2056, a HER2-targeting Immunosynthen ADC, is ongoing, with Mersana achieving a $15 million development milestone from GSK and expecting initial clinical pharmacodynamic STING activation data in the second half of 2025 - The dose escalation portion of the Phase 1 clinical trial for XMT-2056, targeting a novel HER2 epitope, is currently ongoing[9](index=9&type=chunk) - In July 2025, Mersana achieved a **$15 million** development milestone under its agreement with GSK, with payment due in **Q3 2025**[9](index=9&type=chunk) - Initial clinical pharmacodynamic STING activation data for XMT-2056 is expected to be presented in the **second half of 2025**[9](index=9&type=chunk) [Collaborations](index=2&type=section&id=Collaborations) The company continues to support its ongoing research collaborations with Johnson & Johnson for the Dolasynthen platform and with Merck KGaA, Darmstadt, Germany for the Immunosynthen platform - Mersana continues to support its Dolasynthen research collaboration with Johnson & Johnson and its Immunosynthen research collaboration with Merck KGaA, Darmstadt, Germany[10](index=10&type=chunk) [Corporate Developments](index=2&type=section&id=Corporate%20Developments) Mersana executed a 1-for-25 reverse stock split in late July 2025, which successfully reduced the number of outstanding shares and led to regaining compliance with Nasdaq's minimum bid price requirement in August 2025 - A **1-for-25 reverse stock split** became effective on July 25, 2025, reducing outstanding common stock from approximately **124.8 million shares to 5.0 million shares**[11](index=11&type=chunk) - On August 11, 2025, the company received formal notification from Nasdaq confirming it had regained compliance with the minimum bid price requirement[12](index=12&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) For Q2 2025, Mersana reported a net loss of $24.3 million, nearly identical to the prior year, with increased collaboration revenue, decreased R&D and G&A expenses, and $77.0 million in cash and cash equivalents expected to fund operations into mid-2026 - Cash and cash equivalents were **$77.0 million** as of June 30, 2025, with capital resources expected to fund operations into **mid-2026**[13](index=13&type=chunk) Second Quarter 2025 Key Financials | Financial Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | | :--- | :--- | :--- | | Collaboration Revenue | $3.1 | $2.3 | | R&D Expense | $16.2 | $17.2 | | G&A Expense | $7.4 | $10.5 | | Restructuring Expenses | $3.9 | $0 | | Net Loss | $(24.3) | $(24.3) | | Net Loss Per Share | $(4.87) | $(4.96) | - The decrease in R&D and G&A expenses was primarily related to lower headcount and related employee compensation costs[16](index=16&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) The condensed consolidated financial statements detail Mersana's financial position as of June 30, 2025, and operational results for the three and six months then ended, including cash, assets, liabilities, and net loss [Selected Condensed Consolidated Balance Sheet Data](index=5&type=section&id=Selected%20Condensed%20Consolidated%20Balance%20Sheet%20Data) As of June 30, 2025, Mersana had $77.0 million in cash, cash equivalents, and marketable securities, a decrease from year-end 2024, with total assets at $84.6 million, total liabilities at $137.7 million, and a total stockholders' deficit of $53.1 million Selected Condensed Consolidated Balance Sheet Data | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $76,972 | $134,620 | | Total assets | $84,573 | $144,663 | | Total liabilities | $137,719 | $154,172 | | Total stockholders' deficit | $(53,146) | $(9,509) | [Condensed Consolidated Statement of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations) For the three months ended June 30, 2025, Mersana reported collaboration revenue of $3.1 million and total operating expenses of $27.6 million, resulting in a net loss of $24.3 million, or $4.87 per share, comparable to the prior year Condensed Consolidated Statement of Operations | (in thousands, except per share data) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | | :--- | :--- | :--- | | Collaboration revenue | $3,056 | $2,293 | | Research and development | $16,218 | $17,245 | | General and administrative | $7,415 | $10,503 | | Restructuring expenses | $3,940 | - | | **Total operating expenses** | **$27,573** | **$27,748** | | **Net loss** | **$(24,296)** | **$(24,268)** | | **Net loss per share — basic and diluted** | **$(4.87)** | **$(4.96)** |

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 001-41462 SBC Medical Group Holdings Incorporated (Exact Name of Registrant as Specified in Its Charter) Delaware 88-1192 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the transition period from __________ to __________ Commission File Number: 001-41462 Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 SBC Medical Group Holdings Incorporated (Exact Name of Registrant as Specified in Its Charter) Delaware 88-1192 ...