[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 ...

[DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS](index=4&type=section&id=DISCLOSURE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section outlines the nature of forward-looking statements, which are subject to risks and uncertainties that could cause actual results to differ materially - Forward-looking statements are based on current beliefs, expectations, or assumptions about the future of the business, plans, strategies, and operational results, rather than historical facts[7](index=7&type=chunk) - These statements are subject to known and unknown risks and uncertainties, as well as assumptions that could cause actual results to differ materially from those projected[7](index=7&type=chunk)[9](index=9&type=chunk) - Key areas covered by forward-looking statements include contingent payments, R&D costs, foreign currency risk, fair value estimates, competition, patent terms, corporate strategy, liquidity, Nasdaq listing, business growth drivers, product candidate development timelines, legal proceedings, and the impact of global events and healthcare reforms[8](index=8&type=chunk)[11](index=11&type=chunk) [PART I — FINANCIAL INFORMATION](index=7&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This part presents the company's unaudited interim financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=7&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements, providing a snapshot of the company's financial position and performance [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section details the company's assets, liabilities, and shareholders' deficit at the end of the reporting period **Condensed Consolidated Balance Sheet Highlights** | Metric | June 30, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Cash | $4,510,119 | $13,291,167 | $(8,781,048) | | Total current assets | $9,509,496 | $18,911,456 | $(9,401,960) | | Total current liabilities | $9,824,087 | $2,218,425 | $7,605,662 | | Total liabilities | $9,892,074 | $2,423,280 | $7,468,794 | | Total shareholders' (deficit) equity | $(382,578) | $16,488,176 | $(16,870,754) | | Accumulated deficit | $(108,152,005) | $(90,687,073) | $(17,464,932) | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section presents the company's operating expenses and net loss for the reported interim periods **Condensed Consolidated Statements of Operations Highlights** | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $8,749,784 | $1,625,821 | $14,214,034 | $3,749,599 | | General and administrative | $1,434,877 | $1,087,885 | $3,430,723 | $2,640,758 | | Total operating expenses | $10,184,661 | $2,713,706 | $17,644,757 | $6,390,357 | | Net loss | $(10,117,029) | $(2,623,657) | $(17,464,932) | $(6,258,745) | | Net loss per share (basic & diluted) | $(0.29) | $(0.13) | $(0.50) | $(0.32) | - Research and development expenses increased significantly by **438%** for the three months ended June 30, 2025, and **284%** for the six months ended June 30, 2025, compared to the prior year periods[17](index=17&type=chunk) [Condensed Consolidated Statements of Changes in Shareholders' Deficit](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders'%20Deficit) This section details the changes in the components of shareholders' deficit during the reporting period **Changes in Shareholders' Deficit (January 1, 2025 to June 30, 2025)** | Item | Balance, Jan 1, 2025 | Share-based compensation expense | Re-measurement of liability-classified CAD stock options | Net loss | Balance, June 30, 2025 | | :--- | :--- | :--- | :--- | :--- | :--- | | Additional Paid-in Capital | $107,546,433 | $457,310 | $136,868 | — | $108,140,611 | | Accumulated Deficit | $(90,687,073) | — | — | $(17,464,932) | $(108,152,005) | | Total Shareholders' (Deficit) Equity | $16,488,176 | $457,310 | $136,868 | $(17,464,932) | $(382,578) | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes the cash inflows and outflows from operating, investing, and financing activities **Condensed Consolidated Statements of Cash Flows Highlights** | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net Loss | $(17,464,932) | $(6,258,745) | | Net cash used in operating activities | $(8,781,048) | $(11,795,957) | | Net cash provided by financing activities | — | $190,274 | | Net decrease in cash | $(8,781,048) | $(11,605,683) | | Cash at end of period | $4,510,119 | $992,463 | - Cash used in operating activities decreased by **$3.0 million** for the six months ended June 30, 2025, compared to the same period in 2024, despite a higher net loss, due to favorable changes in operating assets and liabilities, particularly increases in accrued liabilities and accounts payable[24](index=24&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed disclosures and explanations of the amounts presented in the financial statements [1. DESCRIPTION OF BUSINESS](index=12&type=section&id=1.%20DESCRIPTION%20OF%20BUSINESS) This note describes the company's focus on developing therapies for neurodegenerative diseases and its current financial challenges - ProMIS Neurosciences Inc. develops antibody therapies and therapeutic vaccines for neurodegenerative diseases like Alzheimer's, MSA, and ALS, focusing on misfolded proteins[27](index=27&type=chunk) - The company's lead product candidates include PMN310 for AD, PMN267 for ALS, and PMN442 for MSA and Parkinson's disease, all designed to selectively target toxic misfolded proteins[28](index=28&type=chunk) - The company's success is dependent on obtaining regulatory approvals, marketing products, and securing additional financing, with management expressing **substantial doubt about its ability to continue as a going concern** due to ongoing losses and funding needs[30](index=30&type=chunk)[31](index=31&type=chunk) [2. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=13&type=section&id=2.%20BASIS%20OF%20PRESENTATION%20AND%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines the accounting principles and policies used in preparing the financial statements - The financial statements are prepared in conformity with U.S. GAAP and include all normal recurring adjustments necessary for fair presentation[35](index=35&type=chunk)[36](index=36&type=chunk) - The company operates as a single operating segment (life science) and consolidates its wholly-owned subsidiary, ProMIS USA[38](index=38&type=chunk)[40](index=40&type=chunk) - As an Emerging Growth Company, ProMIS has elected to use the extended transition period for complying with new or revised accounting standards[41](index=41&type=chunk) [3. FAIR VALUE MEASUREMENTS](index=17&type=section&id=3.%20FAIR%20VALUE%20MEASUREMENTS) This note provides details on the fair value hierarchy for financial assets and liabilities **Fair Value Measurements (June 30, 2025)** | Category | Level 1 | Level 2 | Level 3 | Total | | :--- | :--- | :--- | :--- | :--- | | Short-term investments | $33,051 | $— | $— | $33,051 | | Share-based compensation liability | $— | $— | $62,395 | $62,395 | | Warrant liability | $— | $— | $5,592 | $5,592 | **Fair Value Measurements (December 31, 2024)** | Category | Level 1 | Level 2 | Level 3 | Total | | :--- | :--- | :--- | :--- | :--- | | Short-term investments | $33,051 | $— | $— | $33,051 | | Share-based compensation liability | $— | $— | $199,263 | $199,263 | | Warrant liability | $— | $— | $5,592 | $5,592 | - Share-based compensation liability decreased from **$199,263** at December 31, 2024, to **$62,395** at June 30, 2025[45](index=45&type=chunk) [4. PREPAID EXPENSES AND OTHER CURRENT ASSETS](index=17&type=section&id=4.%20PREPAID%20EXPENSES%20AND%20OTHER%20CURRENT%20ASSETS) This note details the components of prepaid expenses and other current assets **Prepaid Expenses and Other Current Assets** | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Upfront research payments | $4,759,310 | $5,087,692 | | Accrued interest and other receivables | $29,484 | $78,034 | | Insurance | $89,136 | $335,976 | | License fees | $75,352 | $38,255 | | Miscellaneous | $13,044 | $47,281 | | **Total** | **$4,966,326** | **$5,587,238** | [5. ACCRUED LIABILITIES AND ACCOUNTS PAYABLE](index=17&type=section&id=5.%20ACCRUED%20LIABILITIES%20AND%20ACCOUNTS%20PAYABLE) This note details the components of accrued liabilities **Accrued Liabilities** | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Legal | $33,931 | $44,610 | | Accounting | $138,096 | $95,182 | | Research and development | $6,564,059 | $223,559 | | Severance | $303,546 | $38,328 | | Other | $4,276 | $79,283 | | **Total** | **$7,043,908** | **$480,962** | - Research and development accrued liabilities increased by over **$6.3 million** from December 31, 2024, to June 30, 2025[47](index=47&type=chunk) [6. EQUITY](index=19&type=section&id=6.%20EQUITY) This note describes the company's equity structure, including common shares, warrants, and recent financing activities **Common Shares Reserved for Future Issuance** | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Warrants | 57,141,386 | 57,141,386 | | Options issued and outstanding | 3,760,859 | 3,574,453 | | Deferred Share Units granted | 1,061 | 1,061 | | Common Shares available for grant | 2,776,979 | 2,963,385 | | **Total** | **63,680,285** | **63,680,285** | - In July 2024, the company completed a private placement (PIPE) raising **$30.3 million** gross proceeds, involving common share units and pre-funded units with various warrants[53](index=53&type=chunk)[54](index=54&type=chunk) - The Tranche A and B Warrants from the July 2024 PIPE were initially classified as liabilities due to shareholder approval requirements, then reclassified to equity after approval on October 23, 2024, resulting in a **$22.5 million** change in fair value recorded as other income (expense)[57](index=57&type=chunk)[59](index=59&type=chunk) [7. WARRANTS](index=23&type=section&id=7.%20WARRANTS) This note provides a summary of the outstanding common share warrants **Outstanding Common Share Warrants (June 30, 2025)** | Exercise Price ($) | Number of Warrants | Expiry Date | | :--- | :--- | :--- | | C$12.00 | 279,613 | November 2025 | | US$2.02 | 14,128,696 | January 2026 | | US$12.60 | 524,088 | August 2026 | | US$9.60 | 146,744 | August 2026 | | US$2.02 | 14,128,696 | January 2027 | | US$7.50 | 345,938 | April 2028 | | US$6.10 | 69,188 | April 2028 | | US$1.75 | 11,227,714 | February 2029 | | US$2.50 | 14,128,696 | July 2029 | | US$0.01 | 2,162,013 | None | | **Total** | **57,141,386** | | - No warrant exercises occurred during the three or six months ended June 30, 2025[64](index=64&type=chunk) [8. SHARE-BASED COMPENSATION](index=23&type=section&id=8.%20SHARE-BASED%20COMPENSATION) This note details the company's stock option plans and related compensation expenses - The 2025 Stock Option Plan replaced the 2015 plan, reserving **2,946,719 Common Shares** for issuance, with **2,776,979 options** available for grant as of June 30, 2025[65](index=65&type=chunk) **Share-based Compensation Expense** | Expense Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $37,883 | $3,813 | $75,557 | $7,625 | | General and administrative | $174,132 | $14,186 | $381,753 | $73,958 | | **Total** | **$212,015** | **$17,999** | **$457,310** | **$81,583** | - Total share-based compensation expense significantly increased to **$457,310** for the six months ended June 30, 2025, from **$81,583** in the prior year, with a substantial portion allocated to general and administrative expenses[72](index=72&type=chunk) [9. SEGMENT REPORTING](index=27&type=section&id=9.%20SEGMENT%20REPORTING) This note describes the company's single operating segment and related financial information - The company has one reportable segment: life science, which involves the development of clinical and preclinical product candidates[73](index=73&type=chunk) - The CODM (Chief Executive Officer) assesses segment performance based on net income (loss) and cash forecast models, as the company has not generated any product revenue to date[75](index=75&type=chunk)[76](index=76&type=chunk) **Segment Operating Expenses and Net Loss** | Expense Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | PMN310 development program costs | $8,050,610 | $1,073,864 | $12,776,951 | $2,623,174 | | Total Operating Expenses | $10,184,661 | $2,713,706 | $17,644,757 | $6,390,357 | | Net Loss | $10,117,029 | $2,623,657 | $17,464,932 | $6,258,745 | [10. RELATED PARTY TRANSACTIONS](index=28&type=section&id=10.%20RELATED%20PARTY%20TRANSACTIONS) This note discloses transactions with related parties, including a collaborative research agreement - The company has a collaborative research agreement (CRA) with UBC and Vancouver Coastal Health Authority, extended to February 2026, with aggregate funding increased to **C$5,830,000**[80](index=80&type=chunk) **Related Party Transaction Costs (UBC CRA)** | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Cash payments | $283,600 | $149,160 | | Incurred costs | $283,307 | $294,333 | [11. COMMITMENTS AND CONTINGENCIES](index=28&type=section&id=11.%20COMMITMENTS%20AND%20CONTINGENCIES) This note outlines the company's contractual commitments and potential contingencies - Compensation under research, development, and license agreements typically includes upfront fees, milestone payments, and royalty payments, with no accruals for milestone or royalty amounts required as of June 30, 2025[81](index=81&type=chunk)[82](index=82&type=chunk)[83](index=83&type=chunk) - The company has an ongoing license agreement with UBC, requiring an annual license fee of **C$25,000**, and indemnification agreements with its directors and officers[85](index=85&type=chunk)[86](index=86&type=chunk) [12. NET LOSS PER SHARE](index=30&type=section&id=12.%20NET%20LOSS%20PER%20SHARE) This note explains the calculation of basic and diluted net loss per share **Net Loss Per Share (Basic and Diluted)** | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net loss | $(10,117,029) | $(2,623,657) | $(17,464,932) | $(6,258,745) | | Weighted-average shares outstanding (basic and diluted) | 34,851,203 | 19,770,739 | 34,851,203 | 19,544,908 | | Net loss per share (basic and diluted) | $(0.29) | $(0.13) | $(0.50) | $(0.32) | - Stock options and warrants were excluded from diluted net loss per share calculation as their effect would be anti-dilutive[87](index=87&type=chunk)[88](index=88&type=chunk) **Potentially Dilutive Common Shares Equivalents Excluded** | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Options issued and outstanding | 3,760,859 | 1,087,493 | | Warrants | 54,979,373 | 12,793,270 | | Series 2 Convertible Preferred Shares | — | 1,166,667 | | Deferred Share Units | 1,061 | 1,061 | | **Total** | **58,741,293** | **15,048,491** | [13. SUBSEQUENT EVENTS](index=31&type=section&id=13.%20SUBSEQUENT%20EVENTS) This note describes significant events that occurred after the balance sheet date - On July 21, 2025, the company terminated its At-the-Market (ATM) Offering Agreement[89](index=89&type=chunk) - In July 2025, the company received aggregate gross proceeds of **$21.6 million** from a registered direct offering ($0.8 million), two private placements ($2.4 million and $3.0 million), and discounted warrant exercises ($15.9 million)[90](index=90&type=chunk)[91](index=91&type=chunk)[94](index=94&type=chunk)[95](index=95&type=chunk) - The July 22, 2025, and July 29, 2025, PIPE offerings involved the sale of warrants to purchase **12,616,821** and **15,616,360** Common Shares, respectively, both with an exercise price of **$1.25 per share**[91](index=91&type=chunk)[93](index=93&type=chunk)[94](index=94&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition, results of operations, and liquidity, emphasizing significant operating losses and the need for additional funding [Overview](index=34&type=section&id=Overview) This section provides a high-level summary of the company's business, financial performance, and going concern uncertainty - ProMIS is developing antibody therapies for neurodegenerative diseases (AD, MSA, ALS) by selectively targeting misfolded toxic proteins using its patented technology platform[97](index=97&type=chunk)[98](index=98&type=chunk) - The company has incurred significant operating losses since inception, with a net loss of **$17.5 million** for the six months ended June 30, 2025, and an accumulated deficit of **$108.2 million**[100](index=100&type=chunk) - Management believes there is **substantial doubt** about the company's ability to continue as a going concern, requiring significant additional funding to support operations and growth strategy[102](index=102&type=chunk)[104](index=104&type=chunk) [Program Updates](index=36&type=section&id=Program%20Updates) This section details the progress of the company's key therapeutic development programs - PMN310, the lead product candidate for Alzheimer's disease, is in a Phase 1b clinical trial (PRECISE-AD), with all of Cohort 1 and over **50% of Cohort 2 enrolled**, and no cases of ARIA observed to date[105](index=105&type=chunk)[106](index=106&type=chunk)[108](index=108&type=chunk) - PMN310 received **FDA Fast Track Designation** on July 21, 2025, recognizing its potential to address an unmet medical need in AD[108](index=108&type=chunk) - Six-month interim data for PMN310 is anticipated in **Q2 2026**, with topline results expected in **Q4 2026**[108](index=108&type=chunk) - PMN267 (ALS) and PMN442 (MSA) have been humanized and are ready to progress to IND-enabling studies, contingent on sufficient resources[110](index=110&type=chunk)[112](index=112&type=chunk) [Recent Corporate Highlights](index=38&type=section&id=Recent%20Corporate%20Highlights) This section summarizes key corporate achievements and financing activities - PMN310 was granted **Fast Track Designation** by the FDA on July 21, 2025[118](index=118&type=chunk) - As of August 13, 2025, over **50% of planned patient enrollment** for the PMN310 trial has been achieved, with no observed cases of ARIA[118](index=118&type=chunk) - In July 2025, the company received aggregate gross proceeds of **$21.6 million** across multiple transactions, including a registered direct offering, private placements, and discounted warrant exercises[118](index=118&type=chunk) [Components of Operating Results](index=38&type=section&id=Components%20of%20Operating%20Results) This section breaks down the key components of the company's operating results [Revenue](index=38&type=section&id=Revenue) This subsection clarifies the company's current revenue status - The company has not generated any revenue since its inception and does not expect to generate significant revenue from product sales in the near future[116](index=116&type=chunk) [Operating Expenses](index=38&type=section&id=Operating%20Expenses) This subsection details the primary categories of operating expenses [Research and Development Expenses](index=38&type=section&id=Research%20and%20Development%20Expenses) This section describes the costs associated with the company's research and development activities - Research and development expenses primarily consist of employee-related expenses, external research and development expenses (e.g., CROs, consultants), costs for acquiring, developing, and manufacturing clinical study materials, and costs associated with preclinical and clinical activities[117](index=117&type=chunk)[126](index=126&type=chunk) - These expenses are expected to increase substantially as the company advances its product candidates through clinical development and seeks regulatory approvals[121](index=121&type=chunk) [General and Administrative Expenses](index=40&type=section&id=General%20and%20Administrative%20Expenses) This section describes the costs associated with administrative and corporate functions - General and administrative expenses primarily include personnel costs (salary, bonus, benefits, share-based compensation), intellectual property development and protection costs, professional service fees, and other general overhead and facility costs[123](index=123&type=chunk) - These expenses are expected to increase substantially to support business growth and ongoing research and development activities[123](index=123&type=chunk) [Other (Expense) Income](index=40&type=section&id=Other%20(Expense)%20Income) This section describes other non-operating income and expenses - Other (expense) income primarily consists of interest expense on deferred accounts payable, changes in the fair value of financial instruments, and interest income[124](index=124&type=chunk) [Results of Operations - Six Months Ended June 30, 2025 and 2024](index=40&type=section&id=Results%20of%20Operations%20-%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) This section provides a comparative analysis of operating results for the six-month periods **Results of Operations (Six Months Ended June 30)** | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $14,214,034 | $3,749,599 | $10,464,435 | | General and administrative | $3,430,723 | $2,640,758 | $789,965 | | Total operating expenses | $17,644,757 | $6,390,357 | $11,254,400 | | Net loss | $(17,464,932) | $(6,258,745) | $(11,206,187) | - Research and development expenses increased by **$10.5 million (284%)** for the six months ended June 30, 2025, primarily due to the PMN310 phase 1b trial[128](index=128&type=chunk) - General and administrative expenses increased by **$0.8 million (31%)**, driven by higher employee salaries and benefits (including severance costs) and facility-related costs, partially offset by decreased professional and consulting fees[129](index=129&type=chunk) [Results of Operations - Three Months Ended June 30, 2025 and 2024](index=44&type=section&id=Results%20of%20Operations%20-%20Three%20Months%20Ended%20June%2030,%202025%20and%202024) This section provides a comparative analysis of operating results for the three-month periods **Results of Operations (Three Months Ended June 30)** | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $8,749,784 | $1,625,821 | $7,123,963 | | General and administrative | $1,434,877 | $1,087,885 | $346,992 | | Total operating expenses | $10,184,661 | $2,713,706 | $7,470,955 | | Net loss | $(10,117,029) | $(2,623,657) | $(7,493,372) | - Research and development expenses increased by **$7.1 million (438%)** for the three months ended June 30, 2025, primarily due to the PMN310 phase 1b trial[132](index=132&type=chunk) - General and administrative expenses increased by **$0.3 million (32%)**, driven by higher employee salaries, benefits, and share-based compensation, partially offset by decreased patent and professional/consulting fees[133](index=133&type=chunk)[134](index=134&type=chunk) [Liquidity and Capital Resources](index=46&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's financial liquidity, capital resources, and funding needs [Sources of Liquidity](index=46&type=section&id=Sources%20of%20Liquidity) This subsection details the company's primary sources of funding and its current financial position - The company is a pre-revenue development stage company, financing operations through the sale of equity and debt securities and the conversion of warrants and share options[136](index=136&type=chunk) - As of June 30, 2025, cash was **$4.5 million**, with a net loss of **$17.5 million** and negative cash flow from operations of **$8.8 million** for the six months ended June 30, 2025[146](index=146&type=chunk) - In July 2025, the company received aggregate gross proceeds of **$21.6 million** from a registered direct offering, private placements, and discounted warrant exercises[145](index=145&type=chunk)[146](index=146&type=chunk) - Management believes these conditions raise **substantial doubt** about the company's ability to continue as a going concern within the next 12 months, requiring additional funding for future clinical activities and existing liabilities[146](index=146&type=chunk) [Cash Flows](index=48&type=section&id=Cash%20Flows) This subsection provides a detailed analysis of the company's cash flow activities [Cash Flows Used in Operating Activities](index=48&type=section&id=Cash%20Flows%20Used%20in%20Operating%20Activities) This section analyzes the cash used for the company's principal operations - Cash used in operating activities was **$8.8 million** for the six months ended June 30, 2025, primarily due to a net loss of **$17.5 million**, partially offset by non-cash adjustments and favorable changes in operating assets and liabilities[148](index=148&type=chunk) - For the six months ended June 30, 2024, cash used in operating activities was **$11.8 million**, driven by a net loss of **$6.3 million** and a net change of **$5.5 million** in operating assets and liabilities, including a **$5.9 million** repayment on deferred accounts payable[149](index=149&type=chunk)[150](index=150&type=chunk) [Cash Flows Used in Investing Activities](index=50&type=section&id=Cash%20Flows%20Used%20in%20Investing%20Activities) This section analyzes cash flows related to the acquisition and disposal of long-term assets - There was no cash used in investing activities during the six months ended June 30, 2025, or 2024[151](index=151&type=chunk) [Cash Flows from Financing Activities](index=50&type=section&id=Cash%20Flows%20from%20Financing%20Activities) This section analyzes cash flows related to equity and debt financing - No cash was provided by financing activities during the six months ended June 30, 2025[152](index=152&type=chunk) - Cash provided by financing activities during the six months ended June 30, 2024, was **$0.2 million** from the sale of Common Shares under the At The Market Offering Agreement[152](index=152&type=chunk) [Critical Accounting Policies and Estimates](index=50&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section highlights the accounting policies and estimates that are most critical to the financial statements - The company's financial statements are prepared in accordance with U.S. GAAP, requiring management to make significant judgments and estimates, particularly for accruals of research and development expenses[153](index=153&type=chunk) - No material changes to critical accounting estimates have occurred since December 31, 2024[154](index=154&type=chunk) [Recently Issued Accounting Pronouncements](index=50&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) This section discusses the potential impact of new accounting standards - The company is analyzing the impact of ASU 2024-03, which requires disaggregation of income statement expenses, effective for annual periods starting January 1, 2027[43](index=43&type=chunk)[155](index=155&type=chunk) [Emerging Growth Company Status](index=50&type=section&id=Emerging%20Growth%20Company%20Status) This section describes the company's status as an emerging growth company and its implications - The company is an "emerging growth company" under the JOBS Act and has elected to use the extended transition period for adopting new or revised accounting standards[156](index=156&type=chunk)[157](index=157&type=chunk) [Fully Diluted Share Capital](index=50&type=section&id=Fully%20Diluted%20Share%20Capital) This section provides a summary of the company's fully diluted share capital **Fully Diluted Share Capital (June 30, 2025)** | Item | Number of Common Shares and Common Share Equivalents | | :--- | :--- | | Common Shares | 32,689,190 | | Options issued and outstanding | 3,760,859 | | Warrants | 57,141,386 | | Deferred share units | 1,061 | | **Total** | **93,592,496** | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=52&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses the company's exposure to various market risks, including credit, liquidity, and inflation risk - The company is exposed to credit risk, liquidity risk, and inflation risk in its normal course of business[159](index=159&type=chunk) - Credit risk is managed by placing cash with accredited financial institutions and investing in high-quality government and corporate issuers with low credit risk[160](index=160&type=chunk) - Liquidity risk is managed by continuously monitoring actual and projected cash flows and relying on external fundraising, as the company is a pre-revenue development stage entity[161](index=161&type=chunk) - Inflation did not have a material effect on the company's business, financial condition, or results of operations during the six months ended June 30, 2025[162](index=162&type=chunk) [Item 4. Controls and Procedures](index=52&type=section&id=Item%204.%20Controls%20and%20Procedures) This section evaluates the effectiveness of the company's disclosure controls and procedures and discusses internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=52&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This subsection presents management's conclusion on the effectiveness of disclosure controls - The company's management concluded that its disclosure controls and procedures were **not effective** as of June 30, 2025, due to a previously identified material weakness in internal control over financial reporting[164](index=164&type=chunk) [Material Weakness in Internal Control Over Financial Reporting](index=52&type=section&id=Material%20Weakness%20in%20Internal%20Control%20Over%20Financial%20Reporting) This subsection describes the identified material weakness in internal controls - A **material weakness** was identified in the company's internal control over financial reporting due to the failure to design sufficient and appropriate review controls over certain fair value calculations, including the July 2024 PIPE Warrant Liability[165](index=165&type=chunk) - This material weakness could potentially result in a material misstatement of the company's annual or interim financial statements not being prevented or detected on a timely basis[165](index=165&type=chunk) [Remediation Measures](index=54&type=section&id=Remediation%20Measures) This subsection outlines the steps being taken to address the material weakness - The company has implemented measures to remediate the material weakness, including ensuring appropriate levels of review over the calculation of the fair value of its financial instruments, but there is no assurance these initiatives will ultimately have the intended effects[169](index=169&type=chunk) [Changes in Internal Control Over Financial Reporting](index=54&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) This subsection reports any changes to internal controls during the reporting period - Except for the remediation measures related to the material weakness, there have been no other changes in internal control over financial reporting during the three months ended June 30, 2025, that materially affected or are reasonably likely to materially affect it[170](index=170&type=chunk) [PART II — OTHER INFORMATION](index=54&type=section&id=PART%20II%20OTHER%20INFORMATION) This part contains other required disclosures, including legal proceedings, risk factors, and exhibits [Item 1. Legal Proceedings](index=54&type=section&id=Item%201.%20Legal%20Proceedings) This section discloses any material pending legal proceedings - The company is not currently a party to any material litigation or legal proceedings that, in management's opinion, are likely to have a material adverse effect on its business[172](index=172&type=chunk) [Item 1A. Risk Factors](index=54&type=section&id=Item%201A.%20Risk%20Factors) This section highlights key risks that could adversely affect the company's business, financial condition, and results of operations - There is **substantial doubt** about the company's ability to continue as a **going concern** due to incurred losses and the need for significant additional financing to fund development programs and operations[174](index=174&type=chunk)[175](index=175&type=chunk) - The company has identified a **material weakness** in its internal control over financial reporting related to insufficient review controls over fair value measurements, which could adversely affect financial reporting and investor confidence[178](index=178&type=chunk)[179](index=179&type=chunk) - Changes to U.S. fiscal, tax, and other federal policies, including tariffs and tax reforms, could materially and adversely affect the company's business[182](index=182&type=chunk)[183](index=183&type=chunk)[184](index=184&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=58&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports on sales of unregistered equity securities - No unregistered sales of equity securities or use of proceeds occurred during the reporting period[187](index=187&type=chunk) [Item 3. Defaults Upon Senior Securities](index=58&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section reports any defaults on senior securities - No defaults upon senior securities occurred during the reporting period[188](index=188&type=chunk) [Item 4. Mine Safety Disclosures](index=58&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section addresses mine safety disclosures, if applicable - This item is not applicable to the company[189](index=189&type=chunk) [Item 5. Other Information](index=58&type=section&id=Item%205.%20Other%20Information) This section includes any other information not previously reported - No officer or director adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended June 30, 2025[189](index=189&type=chunk) [Item 6. Exhibits](index=59&type=section&id=Item%206.%20Exhibits) This section lists the documents filed as exhibits to the report - The exhibits include forms of Pre-Funded Warrants and Warrants, the 2025 Stock Option and Incentive Plan, Registration Rights Agreements, and certifications required by the Sarbanes-Oxley Act[191](index=191&type=chunk) [Signatures](index=60&type=section&id=Signatures) This section contains the legally required signatures of the company's certifying officers - The report was signed by Neil Warma, Chief Executive Officer, and Daniel Geffken, Chief Financial Officer, on August 13, 2025[197](index=197&type=chunk)

Katapult Delivers Second Quarter Gross Originations, Revenue and Adjusted EBITDA Above Outlook Raising Full Year 2025 Gross Originations Outlook Gross Originations, Revenue and Adjusted EBITDA Growth to Continue In Third Quarter PLANO, Texas, August 13, 2025 — Katapult Holdings, Inc. ("Katapult" or the "Company") (NASDAQ: KPLT), an e-commerce-focused financial technology company, today reported its financial results for the second quarter ended June 30, 2025. "We came out of the gate strong in 2025 and that ...

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 001-40215 Instil Bio, Inc. (Exact name of registrant as specified in its charter) Delaware 83-2072195 (State or other jurisdic ...

Exhibit 99.1 PDS Biotech Reports Second Quarter 2025 Financial Results and Provides Clinical Programs Update Multiple Abstracts Presented at the 2025 American Society of Clinical Oncology Annual Meeting Conference call and webcast today at 8:00 a.m. Eastern Time PRINCETON, N.J., August 13, 2025 -- PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late- stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today provided a business ...

Exhibit 99.1 Aura Biosciences Reports Second Quarter 2025 Financial Results and Business Highlights Continued Clinical Program Execution in the Phase 3 CoMpass Trial in Early Choroidal Melanoma and the Phase 1b/2 Trial in Non-Muscle Invasive Bladder Cancer (NMIBC) Strengthened Balance Sheet with $75 Million Equity Financing; Cash Position Expected to Fund Operations into the First Half of 2027 Metastases to the Choroid Metastases to the choroid is an indication with high unmet medical need and no approved t ...

Table of Contents 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: 001-33407 PERSPECTIVE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) | Del ...