For the Quarterly Period Ended June 30, 2025 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 _______________ FORM 10-Q [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Naples, Florida 34103 Commission File Number: 000-29253 BEASLEY BROADCAST GROUP, INC. OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to (Exact Name of Registrant as Specified in Its Charter) (State ...

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements, including the balance sheets, statements of operations, and cash flows, along with detailed notes explaining the company's business, significant accounting policies, investments, accrued expenses, borrowings, stockholders' equity, stock-based compensation, fair value measurements, revenue recognition, and segment information [Unaudited Condensed Consolidated Balance Sheets](index=5&type=section&id=UNAUDITED%20CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) Unaudited Condensed Consolidated Balance Sheets (in thousands): | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | **Assets** | | | | Cash and cash equivalents | $11,020 | $16,051 | | Short-term investments | $33,765 | $43,249 | | Total current assets | $56,498 | $72,181 | | Total assets | $60,694 | $90,643 | | **Liabilities and Stockholders' Equity** | | | | Accounts payable | $6,172 | $4,569 | | Accrued expenses | $2,477 | $3,793 | | Convertible debt | $— | $13,688 | | Total current liabilities | $10,863 | $24,099 | | Warrant liability | $2,904 | $7,998 | | Total liabilities | $16,227 | $35,566 | | Total stockholders' equity | $44,467 | $55,077 | | Total liabilities and stockholders' equity | $60,694 | $90,643 | [Unaudited Condensed Consolidated Statements of Operations](index=6&type=section&id=UNAUDITED%20CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) Unaudited Condensed Consolidated Statements of Operations (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 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | License agreement revenue | $1,364 | $736 | $1,620 | $2,109 | | Research and development | $7,141 | $6,807 | $12,282 | $14,019 | | Selling, general and administrative | $3,784 | $3,166 | $7,528 | $6,835 | | Total operating expenses | $10,925 | $9,973 | $19,810 | $20,854 | | Loss from operations | $(9,561) | $(9,237) | $(18,190) | $(18,745) | | Warrant liability fair value adjustment | $(2,166) | $5,761 | $(5,094) | $(3,848) | | Net loss | $(6,885) | $(14,458) | $(12,276) | $(14,047) | | Net loss per share – basic and diluted | $(0.14) | $(0.30) | $(0.25) | $(0.29) | [Unaudited Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=UNAUDITED%20CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) Unaudited Condensed Consolidated Statements of Cash Flows (in thousands): | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(14,960) | $(14,867) | | Net cash provided by investing activities | $23,713 | $6,826 | | Net cash used in financing activities | $(14,084) | $(15) | | Net decrease in cash, cash equivalents, and restricted cash | $(5,331) | $(8,056) | | Cash, cash equivalents, and restricted cash at end of period | $11,264 | $26,537 | [Notes to the Condensed Consolidated Financial Statements (unaudited)](index=8&type=section&id=NOTES%20TO%20THE%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) [1. Description of Business and Basis of Preparation](index=8&type=section&id=1.%20Description%20of%20Business%20and%20Basis%20of%20Preparation) SCYNEXIS, Inc. is a biotechnology company focused on developing innovative medicines for difficult-to-treat fungal infections, primarily through its proprietary fungerp platform. The company's lead product, ibrexafungerp (BREXAFEMME), is approved for vulvovaginal candidiasis. A significant development is the ongoing dispute with GSK regarding the MARIO study for invasive candidiasis, where GSK attempted to terminate the study despite the FDA lifting a clinical hold and the company resuming patient dosing, triggering a $10.0 million milestone payment. The company also faces liquidity challenges with an accumulated deficit and a Nasdaq minimum bid price notification - SCYNEXIS is a biotechnology company developing proprietary triterpenoid antifungal compounds ('fungerps') for difficult-to-treat and drug-resistant infections[17](index=17&type=chunk) - Ibrexafungerp (BREXAFEMME) was approved by the FDA in **2021 and 2022** for vulvovaginal candidiasis (VVC) and reduction in recurrent VVC[17](index=17&type=chunk) - The **Phase 3 MARIO study** for ibrexafungerp in invasive candidiasis resumed in **May 2025** after the **FDA lifted a clinical hold** on **April 24, 2025**[19](index=19&type=chunk)[22](index=22&type=chunk) - GSK notified the company of its intention to terminate the **MARIO study** on **April 28, 2025**, claiming no obligation for a **$30.0 million** development milestone. The company disputes GSK's **unilateral termination right**[20](index=20&type=chunk)[21](index=21&type=chunk) - The company billed a **$10.0 million** development milestone to GSK in **Q2 2025** due to the **resumption of patient dosing** in the **MARIO study**[22](index=22&type=chunk) - The company had an **accumulated deficit** of **$388.8 million** and **capital resources** of **$46.5 million** (cash, cash equivalents, and investments) as of **June 30, 2025**[24](index=24&type=chunk) - On **June 20, 2025**, the company received a **Nasdaq notification** for non-compliance with the **$1.00 minimum bid price rule**, with a compliance date of **December 17, 2025**[27](index=27&type=chunk)[28](index=28&type=chunk) [2. Summary of Significant Accounting Policies](index=10&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines the company's accounting policies, including the calculation of basic and diluted net loss per share, and details the impact of recently adopted and issued accounting pronouncements, as well as newly enacted income tax legislation - Basic net loss per common share calculation includes outstanding prefunded warrants from **April 2022** (**7,516,267 shares**) and **December 2020** (**3,200,000 shares**) public offerings[33](index=33&type=chunk) Potentially Dilutive Shares Not Included in Diluted Net Loss Per Share (as of June 30): | Item | 2025 | 2024 | | :---------------------------------------------------- | :--------- | :--------- | | Outstanding stock options | 3,664,841 | 2,842,808 | | Outstanding restricted stock units | 3,139,084 | 3,263,345 | | Warrants to purchase common stock (April 2022 offering) | 15,000,000 | 15,000,000 | | Warrants to purchase common stock (loan agreement) | 198,811 | 198,811 | | Common stock (March 2019 Notes) | — | 1,138,200 | | Warrants to purchase common stock (Danforth) | 50,000 | 50,000 | | **Total** | **22,052,736** | **22,493,164** | - The company adopted **ASU 2023-07** (Segment Reporting) in the prior annual reporting period and **ASU 2023-09** (Income Taxes) is effective for annual periods beginning **January 1, 2025**, with no material impact expected[35](index=35&type=chunk)[36](index=36&type=chunk) - **ASU 2024-03** (Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures) is effective **January 1, 2027**, and its impact is currently being evaluated[37](index=37&type=chunk) - The **One Big Beautiful Bill Act (OBBBA)**, enacted **July 4, 2025**, is not currently expected to materially impact the company's effective tax rate or cash flows in the current fiscal year[38](index=38&type=chunk) [3. Investments](index=11&type=section&id=3.%20Investments) This note provides a summary of the company's investments, primarily in corporate and agency bonds, categorized by maturity. It details their amortized cost, unrealized gains/losses, and fair value, noting that fair values are determined using Level 2 inputs Summary of Investments (in thousands): | Category | June 30, 2025 Fair Value | December 31, 2024 Fair Value | | :----------------------- | :----------------------- | :----------------------- | | Short-term investments | $33,782 | $43,316 | | Long-term investments | $1,739 | $15,808 | | **Total Fair Value** | **$35,521** | **$59,124** | - Investments are carried at amortized cost, and their fair values are determined based on "**Level 2**" inputs[40](index=40&type=chunk) [4. Prepaid Expenses and Other Current Assets](index=12&type=section&id=4.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) This note details the composition of prepaid expenses and other current assets, showing a decrease from December 31, 2024, to June 30, 2025, primarily driven by a reduction in prepaid research and development services Prepaid Expenses and Other Current Assets (in thousands): | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Prepaid research and development services | $74 | $514 | | Prepaid insurance | $477 | $267 | | Other prepaid expenses | $160 | $169 | | Other current assets | $867 | $1,234 | | **Total** | **$1,578** | **$2,184** | [5. Accrued Expenses](index=12&type=section&id=5.%20Accrued%20Expenses) This note provides a breakdown of accrued expenses, indicating a decrease from December 31, 2024, to June 30, 2025, mainly due to lower accrued employee bonus compensation and research and development expenses Accrued Expenses (in thousands): | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Accrued research and development expenses | $328 | $684 | | Accrued employee bonus compensation | $834 | $1,763 | | Other accrued expenses | $757 | $788 | | Accrued product recall | $558 | $558 | | **Total** | **$2,477** | **$3,793** | [6. Borrowings and Contingencies](index=12&type=section&id=6.%20Borrowings%20and%20Contingencies) This note details the repayment of the March 2019 Senior Convertible Notes and provides updates on ongoing legal proceedings, including a securities class action and shareholder derivative complaints related to alleged misstatements about cross-contamination risks and internal controls - The **$14.0 million** principal amount of the **March 2019 Senior Convertible Notes** was fully repaid at maturity on **March 15, 2025**[44](index=44&type=chunk) - A **securities class action lawsuit**, filed **November 7, 2023**, alleges the company made misleading statements regarding cross-contamination risks in ibrexafungerp manufacturing and inadequate internal controls. The court granted the company's **motion to dismiss with leave to amend** on **July 30, 2025**[46](index=46&type=chunk) - **Shareholder derivative complaints**, filed **May and June 2024**, assert state and federal claims based on similar alleged misstatements as the class action. These cases are consolidated and stayed, with the company intending to vigorously defend them[47](index=47&type=chunk) [7. Stockholders' Equity](index=14&type=section&id=7.%20Stockholders'%20Equity) This note provides a summary of common stock activity, including shares issued and outstanding, and a detailed table of shares reserved for future issuance under various plans and warrants Common Stock Issued and Outstanding: | Date | Shares Issued and Outstanding | | :---------------- | :---------------------------- | | June 30, 2025 | 39,174,941 | | December 31, 2024 | 37,973,991 | - In **August 2025**, a **5%** beneficial owner exercised **2,750,000 prefunded warrants** from the **April 2022** public offering, resulting in the issuance of **2,750,000 common shares** for **$2,750**[48](index=48&type=chunk) Common Shares Reserved for Future Issuance: | Item | June 30, 2025 | December 31, 2024 | | :---------------------------------------------------- | :------------ | :---------------- | | Outstanding stock options | 3,664,841 | 2,905,029 | | Outstanding restricted stock units | 3,139,084 | 3,120,374 | | Prefunded warrants (Dec 2020 offering) | 3,200,000 | 3,200,000 | | Warrants (April 2022 offering) | 15,000,000 | 15,000,000 | | Prefunded warrants (April 2022 offering) | 7,516,267 | 7,516,267 | | Warrants (loan agreement) | 198,811 | 198,811 | | Warrant (Danforth) | 50,000 | 50,000 | | March 2019 Notes conversion | — | 1,138,200 | | 2024 Plan | 3,903,934 | 5,864,196 | | Employee stock purchase plan | 1,399,683 | 1,431,393 | | 2015 Plan | 649,550 | 637,050 | | **Total** | **38,722,170** | **41,061,320** | [8. Stock-based Compensation](index=16&type=section&id=8.%20Stock-based%20Compensation) This note outlines the company's equity incentive plans (2024 Plan, 2015 Plan), summarizes stock option and restricted stock unit (RSU) activity, and details the stock-based compensation expense recognized for the periods - The **2024 Equity Incentive Plan** was adopted in **April 2024** and became effective **June 19, 2024**, succeeding the 2014 Plan. As of **June 30, 2025**, **3,903,934 shares** were available under the **2024 Plan**[53](index=53&type=chunk) Restricted Stock Unit (RSU) Activity (Six Months Ended June 30, 2025): | Metric | Number of Shares | Weighted Average Grant Date Fair Value Per Share | | :-------------------------- | :--------------- | :--------------------------------------------- | | Non-vested at Dec 31, 2024 | 3,120,374 | $1.89 | | Granted | 1,485,949 | $1.05 | | Vested | (1,169,240) | $1.99 | | Forfeited | (297,999) | $1.78 | | Non-vested at June 30, 2025 | 3,139,084 | $1.46 | Stock-based Compensation Expense (in thousands): | Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $202 | $216 | $417 | $411 | | Selling, general and administrative | $618 | $543 | $1,222 | $1,053 | | **Total** | **$820** | **$759** | **$1,639** | **$1,464** | [9. Fair Value Measurements](index=18&type=section&id=9.%20Fair%20Value%20Measurements) This note details the fair value measurements of financial instruments, classifying cash and money market funds as Level 1 assets and the warrant liability as a Level 3 liability. It explains the use of the Black-Scholes model for valuing the warrant liability and provides a reconciliation of its changes Financial Instruments Measured at Fair Value (in thousands): | Item | June 30, 2025 Balance | December 31, 2024 Balance | | :------------------ | :-------------------- | :-------------------- | | Cash | $448 | $3,441 | | Restricted cash | $244 | $544 | | Money market funds | $10,572 | $12,610 | | **Total Level 1 Assets** | **$11,264** | **$16,595** | | Warrant liability | $2,904 | $7,998 | | **Total Level 3 Liabilities** | **$2,904** | **$7,998** | - The **warrant liability** is a **Level 3 financial liability**, valued using the **Black-Scholes option valuation model**, incorporating **unobservable inputs** like **volatility** (**85.4%** at **June 30, 2025**, and **83.4%** at **December 31, 2024**)[59](index=59&type=chunk) Reconciliation of Level 3 Warrant Liabilities (in thousands): | Metric | Amount | | :-------------------------- | :----- | | Balance – December 31, 2024 | $7,998 | | Gain adjustment to fair value | $(5,094) | | Balance – June 30, 2025 | $2,904 | [10. Revenue](index=19&type=section&id=10.%20Revenue) This note details revenue recognition primarily from the GSK License Agreement, including the $10.0 million license agreement receivable associated with the MARIO study milestone. It also highlights the potential impact on financial statements if the dispute with GSK is not resolved favorably - Revenue is primarily derived from the **GSK License Agreement**, which grants GSK exclusive rights for ibrexafungerp in the GSK Territory[61](index=61&type=chunk)[62](index=62&type=chunk) - As of **June 30, 2025**, the company maintains a **$10.0 million license agreement receivable** from GSK, triggered by the resumption of patient dosing in the **Phase 3 MARIO study**[63](index=63&type=chunk) - If the disagreement with GSK over the **MARIO study** is not resolved favorably, the company may need to reverse the **$10.0 million receivable** and recognize remaining deferred revenue, **materially impacting financial statements**[63](index=63&type=chunk) License Agreement Revenue (in thousands): | Period | 2025 | 2024 | | :-------------------------------- | :----- | :----- | | Three Months Ended June 30, | $1,364 | $736 | | Six Months Ended June 30, | $1,620 | $2,109 | Deferred Revenue (in thousands): | Category | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Current portion | $1,770 | $1,642 | | Long-term portion | $515 | $1,294 | [11. Segments](index=19&type=section&id=11.%20Segments) The company operates as a single reportable segment focused on drug development, with the CEO serving as the chief operating decision maker. Performance is assessed based on consolidated net loss, and resources are allocated to drug development programs accordingly - The company has one **reportable segment**: drug development, managing business activities on a consolidated basis[66](index=66&type=chunk) - The **Chief Executive Officer (CEO)** is the **chief operating decision maker (CODM)**, assessing performance and allocating resources based on **consolidated net (loss) income**[66](index=66&type=chunk) Drug Development Segment Net Loss (in thousands): | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue | $1,364 | $736 | $1,620 | $2,109 | | Clinical expense | $2,506 | $2,274 | $4,217 | $4,762 | | Preclinical expense | $1,032 | $646 | $1,969 | $1,181 | | Chemistry, manufacturing, and controls | $1,771 | $1,484 | $2,273 | $3,580 | | Selling, general, and administrative | $3,784 | $3,166 | $7,528 | $6,835 | | Segment net loss | $(6,885) | $(14,458) | $(12,276) | $(14,047) | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&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 and operational results, including an overview of its drug development pipeline, detailed updates on the MARIO study and SCY-247 development, and discussions on liquidity, legal proceedings, and Nasdaq listing compliance. It also breaks down the components of operating results and analyzes financial performance for the three and six months ended June 30, 2025 and 2024 [Overview](index=22&type=section&id=Overview) - SCYNEXIS, Inc. is a biotechnology company focused on developing **novel antifungal agents (fungerps)** to combat **difficult-to-treat and drug-resistant infections**[70](index=70&type=chunk) - Ibrexafungerp (BREXAFEMME) is the **first approved fungerp for vulvovaginal candidiasis**, and a **second-generation fungerp, SCY-247, is currently in clinical trials**[71](index=71&type=chunk)[72](index=72&type=chunk) [MARIO Study and Clinical Hold Update](index=22&type=section&id=MARIO%20Study%20and%20Clinical%20Hold%20Update) - The **Phase 3 MARIO study** for ibrexafungerp was placed on **clinical hold** in **September 2023** due to **potential cross-contamination** at the **drug substance manufacturer's facility**[74](index=74&type=chunk) - The **FDA lifted the clinical hold** on ibrexafungerp on **April 24, 2025**, allowing the **MARIO study to resume**[75](index=75&type=chunk) - GSK notified the company of its intent to terminate the **MARIO study** on **April 28, 2025**, **disputing obligations for a $30.0 million development milestone**. The company believes GSK does not have a **unilateral termination right**[75](index=75&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk) - **Patient dosing in the MARIO study resumed in May 2025**, **triggering a $10.0 million development milestone billed to GSK**[78](index=78&type=chunk) - The **September 2023 cross-contamination issue** also led to a **recall of all commercial BREXAFEMME supplies**, with **GSK responsible for manufacturing new supplies and reintroduction to the market**[79](index=79&type=chunk) [SCY-247 Development Update](index=24&type=section&id=SCY-247%20Development%20Update) - The company completed the **single and multiple ascending dose portions of its Phase 1 study of oral SCY-247** in **88 healthy subjects**[81](index=81&type=chunk) - Data from the **SCY-247 Phase 1 study** (**safety, tolerability, and pharmacokinetics**) is **expected to be released in the third quarter of 2025**[81](index=81&type=chunk) [Nasdaq Minimum Bid Price Notification](index=24&type=section&id=Nasdaq%20Minimum%20Bid%20Price%20Notification) - On **June 20, 2025**, the company received a **Nasdaq notification for failing to meet the $1.00 minimum bid price requirement for 30 consecutive business days**[82](index=82&type=chunk) - The company has **180 calendar days**, until **December 17, 2025**, to **regain compliance by having its common stock close at $1.00 or more for at least 10 consecutive business days**[83](index=83&type=chunk) [Class Action Lawsuit](index=24&type=section&id=Class%20Action%20Lawsuit) - A **securities class action was filed on November 7, 2023**, alleging **misleading statements regarding cross-contamination risks in ibrexafungerp manufacturing and inadequate internal controls**. The **motion to dismiss was granted with leave to amend on July 30, 2025**[84](index=84&type=chunk) - **Shareholder derivative complaints**, filed in **May and June 2024**, assert **similar claims against the company's directors and officers**; these cases are **consolidated and stayed**[85](index=85&type=chunk) [Liquidity](index=25&type=section&id=Liquidity) - As of **June 30, 2025**, the company's **principal source of liquidity was cash, cash equivalents, and investments totaling $46.5 million**[86](index=86&type=chunk) - The company had an **accumulated deficit of $388.8 million** as of **June 30, 2025**, and expects to incur **significant R&D and SG&A expenses, necessitating additional capital**[87](index=87&type=chunk) - Future funding may be obtained through **equity offerings, debt financings, non-dilutive third-party funding, strategic alliances, or licensing/collaboration arrangements**[87](index=87&type=chunk) [Collaborations and Licensing Agreements](index=25&type=section&id=Collaborations%20and%20Licensing%20Agreements) - Key licensing agreements include: **GSK (ibrexafungerp development, manufacture, commercialization)**, **Merck (ibrexafungerp rights, milestones, royalties)**, **Hansoh (ibrexafungerp in Greater China, Chinese VVC approval, milestones, ~10% royalties)**, **R-Pharm (ibrexafungerp in Russia/non-core markets)**, **Waterstone (SCY-635 for viral diseases)**, and **Cypralis (cyclophilin inhibitor assets, milestones, royalties)**[88](index=88&type=chunk) [Components of Operating Results](index=25&type=section&id=Components%20of%20Operating%20Results) [Revenue](index=25&type=section&id=Revenue) - Revenue consists of **license agreement revenue associated with GSK**[89](index=89&type=chunk) [Research and Development Expense](index=25&type=section&id=Research%20and%20Development%20Expense) - R&D expenses include costs for **preclinical/clinical trials, drug formulation, manufacturing, regulatory filings, salaries, and medical affairs**. **Ibrexafungerp and SCY-247 were the only key R&D projects**[90](index=90&type=chunk)[91](index=91&type=chunk) [Selling, General and Administrative Expense](index=26&type=section&id=Selling,%20General%20and%20Administrative%20Expense) - SG&A expenses primarily consist of **salaries, personnel-related costs, facility costs, professional fees (accounting, legal), consulting, patent fees, information systems, and marketing**[93](index=93&type=chunk) [Other Expense (Income)](index=26&type=section&id=Other%20Expense%20(Income)) - Other expense (income) includes **amortization of debt issuance costs and discount, interest income, interest expense, warrant liability fair value adjustment, and derivative liability fair value adjustment**[94](index=94&type=chunk) [Income Tax Expense](index=26&type=section&id=Income%20Tax%20Expense) - Income tax expense for the **six months ended June 30, 2024**, primarily consisted of **U.S. federal income tax**[95](index=95&type=chunk) [Results of Operations for the Three Months Ended June 30, 2025 and 2024](index=26&type=section&id=Results%20of%20Operations%20for%20the%20Three%20Months%20Ended%20June%2030,%202025%20and%202024) Results of Operations (Three Months Ended June 30, in thousands): | Metric | 2025 | 2024 | Change ($) | Change (%) | | :------------------------------------------ | :----- | :----- | :--------- | :--------- | | License agreement revenue | $1,364 | $736 | $628 | 85.3% | | Research and development | $7,141 | $6,807 | $334 | 4.9% | | Selling, general and administrative | $3,784 | $3,166 | $618 | 19.5% | | Total operating expenses | $10,925 | $9,973 | $952 | 9.5% | | Loss from operations | $(9,561) | $(9,237) | $(324) | 3.5% | | Amortization of debt issuance costs and discount | $— | $421 | $(421) | (100.0)% | | Interest income | $(510) | $(1,130) | $620 | (54.9)% | | Interest expense | $— | $197 | $(197) | (100.0)% | | Warrant liability fair value adjustment | $(2,166) | $5,761 | $(7,927) | (137.6)% | | Derivative liability fair value adjustment | $— | $(28) | $28 | (100.0)% | | Total other (income) expense | $(2,676) | $5,221 | $(7,897) | (151.3)% | | Net loss | $(6,885) | $(14,458) | $7,573 | (52.4)% | - **Research and development expenses increased by $0.3 million (5%)** due to increases in **CMC ($0.3M)** and **preclinical ($0.4M)** expenses, partially offset by decreases in salary and other R&D expenses[97](index=97&type=chunk)[99](index=99&type=chunk) - **Selling, general and administrative expenses increased by $0.6 million (20%)** primarily due to a **$0.4 million increase in professional fees**[100](index=100&type=chunk) - A **$2.2 million gain on warrant liability fair value adjustment** was recognized in **Q2 2025**, compared to a **$5.8 million loss** in **Q2 2024**, primarily due to a **decrease in the company's stock price**[103](index=103&type=chunk) [Results of Operations for the Six Months Ended June 30, 2025 and 2024](index=27&type=section&id=Results%20of%20Operations%20for%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) Results of Operations (Six Months Ended June 30, in thousands): | Metric | 2025 | 2024 | Change ($) | Change (%) | | :------------------------------------------ | :----- | :----- | :--------- | :--------- | | License agreement revenue | $1,620 | $2,109 | $(489) | (23.2)% | | Research and development | $12,282 | $14,019 | $(1,737) | (12.4)% | | Selling, general and administrative | $7,528 | $6,835 | $693 | 10.1% | | Total operating expenses | $19,810 | $20,854 | $(1,044) | (5.0)% | | Loss from operations | $(18,190) | $(18,745) | $555 | (3.0)% | | Amortization of debt issuance costs and discount | $312 | $822 | $(510) | (62.0)% | | Interest income | $(1,305) | $(2,402) | $1,097 | (45.7)% | | Interest expense | $173 | $403 | $(230) | (57.1)% | | Warrant liabilities fair value adjustment | $(5,094) | $(3,848) | $(1,246) | 32.4% | | Derivative liabilities fair value adjustment | $— | $(196) | $196 | (100.0)% | | Total other income | $(5,914) | $(5,221) | $(693) | 13.3% | | Loss before taxes | $(12,276) | $(13,524) | $1,248 | (9.2)% | | Income tax expense | $— | $523 | $(523) | (100.0)% | | Net loss | $(12,276) | $(14,047) | $1,771 | (12.6)% | - **Research and development expenses decreased by $1.7 million (12%)** primarily due to a **$1.3 million decrease in CMC expense** and a **$0.5 million decrease in clinical expense**, partially offset by an **$0.8 million increase in preclinical expense**[106](index=106&type=chunk)[107](index=107&type=chunk)[108](index=108&type=chunk) - **Selling, general and administrative expenses increased by $0.7 million (10%)** due to increases in **business development expense ($0.3M)** and **salary expense ($0.3M)**[109](index=109&type=chunk) - A **$5.1 million gain on warrant liabilities fair value adjustment** was recognized in **H1 2025**, compared to a **$3.8 million gain** in **H1 2024**, primarily due to a **decrease in the company's stock price**[112](index=112&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) [Sources of Liquidity](index=29&type=section&id=Sources%20of%20Liquidity) - As of **June 30, 2025**, the company had **$46.5 million in cash, cash equivalents, and investments**, down from **$75.1 million at December 31, 2024**[114](index=114&type=chunk) - The company believes its **capital resources are sufficient for at least 12 months** but anticipates needing **additional capital due to significant R&D and SG&A expenses**[114](index=114&type=chunk)[115](index=115&type=chunk) [Cash Flows](index=30&type=section&id=Cash%20Flows) Cash Flows (Six Months Ended June 30, in thousands): | Activity | 2025 | 2024 | | :-------------------------------- | :----- | :----- | | Net cash used in operating activities | $(14,960) | $(14,867) | | Net cash provided by investing activities | $23,713 | $6,826 | | Net cash used in financing activities | $(14,084) | $(15) | | Net decrease in cash, cash equivalents, and restricted cash | $(5,331) | $(8,056) | - **Net cash used in operating activities increased slightly by $0.1 million** in **H1 2025** compared to **H1 2024**, primarily due to **continued development costs for SCY-247 and ibrexafungerp**[118](index=118&type=chunk) - **Net cash provided by investing activities significantly increased to $23.7 million** in **H1 2025** from **$6.8 million in H1 2024**, driven by **maturities of investments**[121](index=121&type=chunk) - **Net cash used in financing activities increased substantially to $14.1 million** in **H1 2025**, primarily due to the **$14.0 million repayment of convertible debt**[122](index=122&type=chunk) [Future Funding Requirements](index=30&type=section&id=Future%20Funding%20Requirements) - The company anticipates **substantial additional funding will be required** for **ongoing operations**, particularly for **research, development, and clinical trials of product candidates**[123](index=123&type=chunk) - Future capital requirements depend on factors such as the success of the **GSK License Agreement**, clinical development progress of SCY-247 and ibrexafungerp, regulatory approvals, intellectual property, and strategic alliances[125](index=125&type=chunk)[128](index=128&type=chunk) - Funding strategies include **equity offerings (potentially dilutive)**, **debt financings (with covenants)**, **non-dilutive third-party funding**, and **strategic alliances/licensing arrangements (potentially relinquishing rights)**[125](index=125&type=chunk) [Significant Estimates and Judgments](index=32&type=section&id=Significant%20Estimates%20and%20Judgments) - The **preparation of financial statements requires management to make estimates and assumptions** affecting **reported asset/liability amounts and revenue/expense disclosures**, which are **evaluated on an ongoing basis**[126](index=126&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that quantitative and qualitative disclosures about market risk are not applicable to smaller reporting companies - This item is **not applicable to smaller reporting companies**[129](index=129&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms management's evaluation of the effectiveness of the company's disclosure controls and procedures, concluding they were effective as of June 30, 2025. It also states that there have been no material changes in internal control over financial reporting during the quarter [Management's Evaluation of our Disclosure Controls and Procedures](index=33&type=section&id=Management's%20Evaluation%20of%20our%20Disclosure%20Controls%20and%20Procedures) - As of **June 30, 2025**, **management, with the participation of the principal executive and financial officers, concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level**[131](index=131&type=chunk) [Changes in Internal Control Over Financial Reporting](index=33&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) - During the **three months ended June 30, 2025**, there were **no changes in internal control over financial reporting that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting**[132](index=132&type=chunk) [PART II. OTHER INFORMATION](index=33&type=section&id=PART%20II%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) This section provides an update on the legal proceedings, including a securities class action and shareholder derivative complaints, both alleging misstatements regarding cross-contamination risks and internal controls. The company intends to vigorously defend these litigations - A **securities class action**, filed **November 7, 2023**, alleges misleading statements about ibrexafungerp manufacturing and internal controls. The **court granted the company's motion to dismiss with leave to amend on July 30, 2025**[134](index=134&type=chunk) - **Shareholder derivative complaints**, filed **May and June 2024**, assert similar claims against directors and officers, are consolidated, and currently stayed. The company disagrees with the allegations and intends to defend vigorously[135](index=135&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) This section highlights the risk of the company's common stock being delisted from the Nasdaq Global Market due to non-compliance with the minimum $1.00 bid price requirement. The company received a deficiency notice and has until December 17, 2025, to regain compliance - The company received a **Nasdaq notification** on **June 20, 2025**, for failing to maintain a **minimum closing bid price of $1.00 per share for 30 consecutive business days**[138](index=138&type=chunk) - The **compliance date to regain the $1.00 minimum bid price is December 17, 2025**. Failure to comply could lead to **delisting or transfer to the Nasdaq Capital Market**, potentially requiring a **reverse stock split**[139](index=139&type=chunk)[140](index=140&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Form 10-Q, including organizational documents, certifications, and XBRL data files - Exhibits include **Amended and Restated Certificate of Incorporation**, **By-Laws**, **Certifications of CEO and CFO (31.1*, 31.2*, 32.1**), **Inline XBRL Instance Document**, and **Cover Page Interactive Data File**[143](index=143&type=chunk) [Signatures](index=37&type=section&id=Signatures) This section contains the official signatures of the Chief Executive Officer and Chief Financial Officer, certifying the report on behalf of SCYNEXIS, Inc - The report is signed by **David Angulo, M.D., Chief Executive Officer**, and **Ivor Macleod, Chief Financial Officer**, on **August 12, 2025**[148](index=148&type=chunk)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) 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: 001-36790 Predictive Oncology Inc. (Exact name of registrant as specified in its ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Commission file number: 001-40893 CATALYST BANCORP, INC. (Exact name of registrant as specified in its charter) Louisiana 86-2411762 (State or other jurisdiction of incorporation of organization) (I.R.S. Employer Identification No.) 235 N. Court Street, Opelousas, Louisiana 70570 (Address of principal executive offices; Zip Code) (337) 948-3033 (Registrant's telephone number, including area code) None (Former ...

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 _____ (State or other jurisdiction of incorporation or organization) Nevada 83-1019155 Commission File Number: 001-41037 (I.R.S. Employer Identificati ...

[Expion360 Inc. Form 8-K Current Report](index=1&type=section&id=Expion360%20Inc.%20Form%208-K) This report details Expion360 Inc.'s current material events, including preliminary financial results and related exhibits [Company Information](index=1&type=section&id=Company%20Information) Expion360 Inc. is a Nevada-based corporation whose common stock is listed on The Nasdaq Capital Market under the ticker symbol XPON, classified as an emerging growth company - The company's common stock, with a par value of **$0.001 per share**, is registered and trades on The Nasdaq Capital Market under the symbol XPON[3](index=3&type=chunk) - Expion360 Inc. is identified as an emerging growth company as defined by the Securities Act of 1933 and the Securities Exchange Act of 1934[4](index=4&type=chunk) [Item 2.02. Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02.%20Results%20of%20Operations%20and%20Financial%20Condition) On August 4, 2025, Expion360 Inc. issued a press release to announce its selected preliminary unaudited financial results for the second quarter ended June 30, 2025, furnished as Exhibit 99.1 and not considered "filed" for Section 18 of the Securities Exchange Act of 1934 - The company announced select preliminary unaudited financial results for the second quarter ended June 30, 2025, through a press release issued on August 4, 2025[5](index=5&type=chunk) - The information, including the attached Exhibit 99.1, is being furnished and is not deemed "filed" under Section 18 of the Exchange Act, nor is it subject to the liabilities of that section[6](index=6&type=chunk) [Item 9.01. Financial Statements and Exhibits](index=2&type=section&id=Item%209.01.%20Financial%20Statements%20and%20Exhibits) This section lists the exhibits included with the Form 8-K filing, primarily the press release (99.1) detailing the company's financial results Exhibits Filed | Exhibit No. | Description | | :--- | :--- | | 99.1 | Press Release, dated August 4, 2025 | | 104 | Cover Page Interactive Data File (embedded within the inline XBRL document) |

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 001-37536 Conifer Holdings, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organiz ...

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 ☐ 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: 001-42650 RENATUS TACTICAL ACQUISITION CORP I (Exact Name of Registrant as Specified in Its Charter) | Cayman Islands | N/A | | --- | - ...

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 ☐ 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: 001-42650 RENATUS TACTICAL ACQUISITION CORP I (Exact Name of Registrant as Specified in Its Charter) | Cayman Islands | N/A | | --- | - ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) The financial information section presents the unaudited condensed consolidated financial statements, management's discussion and analysis, market risk disclosures, and controls and procedures [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for the period ended June 30, 2025, show a significant increase in net loss and cash used in operations compared to the prior year, with substantial doubt about the company's ability to continue as a going concern [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Items (in thousands) | Balance Sheet Items (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $39,510 | $71,637 | | Total current assets | $42,966 | $75,811 | | Total assets | $46,466 | $79,899 | | **Liabilities & Equity** | | | | Total current liabilities | $20,500 | $15,237 | | Total liabilities | $22,965 | $18,225 | | Accumulated deficit | $(288,833) | $(240,869) | | Total stockholders' equity | $23,501 | $61,674 | - Cash and cash equivalents decreased by **44.8%** from **$71.6 million** at the end of 2024 to **$39.5 million** as of June 30, 2025, reflecting significant cash burn from operations[10](index=10&type=chunk) - Total stockholders' equity declined by **61.9%** to **$23.5 million** from **$61.7 million** at year-end 2024, primarily driven by the net loss incurred during the first six months of 2025[10](index=10&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Operating Results (in thousands) | Operating Results (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $21,196 | $11,296 | $37,353 | $21,594 | | General and administrative | $5,880 | $4,697 | $11,525 | $9,471 | | **Total operating expenses** | **$27,076** | **$15,993** | **$48,878** | **$31,065** | | Loss from operations | $(27,076) | $(15,993) | $(48,878) | $(31,065) | | **Net loss** | **$(26,723)** | **$(14,583)** | **$(47,964)** | **$(28,311)** | - Net loss for the second quarter of 2025 increased by **83.2%** year-over-year to **$26.7 million**, driven by an **87.6%** increase in Research and Development expenses[13](index=13&type=chunk) Per Share Data | Per Share Data | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net loss per share, basic and diluted | $(1.74) | $(0.97) | $(3.16) | $(2.00) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (in thousands) | Cash Flow Summary (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(38,295) | $(27,416) | | Net cash provided by (used in) investing activities | $5 | $(182) | | Net cash provided by financing activities | $6,163 | $47,530 | | **Net (decrease) increase in cash** | **$(32,127)** | **$19,932** | | Cash at beginning of period | $72,054 | $87,304 | | **Cash at end of period** | **$39,927** | **$107,236** | - Net cash used in operating activities increased by **39.7%** to **$38.3 million** for the first six months of 2025, compared to **$27.4 million** in the same period of 2024, reflecting higher operating losses[20](index=20&type=chunk) - Cash from financing activities was significantly lower in the first half of 2025 (**$6.2 million** from ATM offering) compared to the first half of 2024 (**$47.5 million** from an underwritten offering), contributing to the large net decrease in cash[20](index=20&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The company has concluded that substantial doubt exists about its ability to continue as a going concern, as existing cash and cash equivalents of **$39.5 million** are not sufficient to fund operating plans for at least twelve months from the financial statement issuance date[28](index=28&type=chunk)[30](index=30&type=chunk) - In July 2025, the company implemented a corporate reorganization, including a workforce reduction of approximately **50%**, to extend its cash runway, focusing on briquilimab clinical programs in chronic urticaria and halting other programs, with an estimated cost of **$1.9 million** for the reduction[100](index=100&type=chunk)[101](index=101&type=chunk) - The company operates as a single reportable segment focused on the research and development of therapeutic products for chronic urticaria and asthma, with total program costs of **$25.5 million** for the six months ended June 30, 2025, a **107%** increase from **$12.3 million** in the prior year period[98](index=98&type=chunk)[99](index=99&type=chunk) - The company entered into an Open Market Sale Agreement (ATM Offering) in March 2025, raising net proceeds of approximately **$5.9 million** by June 30, 2025, with **$94.1 million** remaining available under the ATM prospectus as of that date[76](index=76&type=chunk)[77](index=77&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on developing briquilimab for mast cell driven diseases, highlighting recent clinical data, an investigation into a drug product lot, and a subsequent corporate reorganization to extend the cash runway, while reiterating substantial doubt about the company's ability to continue as a going concern [Overview and Recent Developments](index=26&type=section&id=Overview%20and%20Recent%20Developments) - The company is a clinical-stage biotech focused on developing briquilimab, a monoclonal antibody targeting the c-Kit receptor on mast cells for diseases like Chronic Spontaneous Urticaria (CSU), Chronic Inducible Urticaria (CIndU), and asthma[110](index=110&type=chunk)[111](index=111&type=chunk) - An investigation is underway for a specific drug product lot used in the BEACON (CSU) and ETESIAN (asthma) studies, which showed an atypical lack of efficacy in certain patient cohorts, leading to halting enrollment in the ETESIAN study[116](index=116&type=chunk)[119](index=119&type=chunk) - On July 8, 2025, the company implemented a corporate reorganization, reducing its workforce by approximately **50%** to extend its cash runway and focus resources on its chronic urticaria clinical development programs[122](index=122&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) Expense Comparison (in thousands) | Expense Comparison (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | $21,196 | $11,296 | +88% | | General and administrative | $5,880 | $4,697 | +25% | | **Total operating expenses** | **$27,076** | **$15,993** | **+69%** | - The **88%** increase in Q2 2025 R&D expenses was driven by a **$9.6 million** rise in program costs, including a **$4.1 million** increase in CRO expenses and a **$5.1 million** increase in CMO manufacturing costs to support clinical programs[143](index=143&type=chunk)[146](index=146&type=chunk) Expense Comparison (in thousands) | Expense Comparison (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | $37,353 | $21,594 | +73% | | General and administrative | $11,525 | $9,471 | +22% | | **Total operating expenses** | **$48,878** | **$31,065** | **+57%** | - For the first six months of 2025, R&D expenses grew by **$15.8 million** (**73%**) year-over-year, primarily due to a **$13.2 million** increase in program costs related to advancing the CSU and asthma trials and higher CMO manufacturing expenses[151](index=151&type=chunk)[154](index=154&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company had cash and cash equivalents of **$39.5 million**[158](index=158&type=chunk) - Management has concluded there is substantial doubt about the company's ability to continue as a going concern within one year, given recurring losses and the current cash position relative to its operating plan[163](index=163&type=chunk) - The company will need to raise substantial additional funding to continue operations, with future financing potentially coming from equity or debt offerings, collaborations, or other arrangements, though there is no assurance of success[162](index=162&type=chunk)[163](index=163&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that there have been no material changes to its market risk during the six months ended June 30, 2025 - There have been no material changes to the company's market risk exposure during the first six months of 2025[182](index=182&type=chunk) [Item 4. Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[184](index=184&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[185](index=185&type=chunk) [PART II. OTHER INFORMATION](index=43&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers other important information including legal proceedings, updated risk factors, equity sales, other disclosures, and a list of exhibits [Item 1. Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - As of the filing date, the company is not involved in any material legal proceedings[187](index=187&type=chunk) [Item 1A. Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) This section updates and reiterates key risks to the business, including financial concerns about going concern, operational risks from clinical trial delays and reorganization, reliance on third parties, and market-related risks - **Financial Risk:** The company has a history of significant net losses and negative cash flows, expects to incur losses for the foreseeable future, and has substantial doubt about its ability to continue as a going concern[189](index=189&type=chunk)[201](index=201&type=chunk) - **Clinical Development Risk:** Delays in clinical trials are a major risk, highlighted by the investigation into a drug product lot used in the BEACON and ETESIAN studies that demonstrated an atypical absence of efficacy[206](index=206&type=chunk)[208](index=208&type=chunk) - **Operational Risk:** The July 2025 corporate reorganization and **~50%** workforce reduction may have unintended consequences, such as loss of expertise and reduced morale, and may not achieve the anticipated benefits[203](index=203&type=chunk) - **Third-Party Reliance Risk:** The company relies heavily on third parties like CROs to conduct clinical trials, and failures by these parties, such as potential manufacturing variability in the investigated drug lot, could substantially harm the business[221](index=221&type=chunk)[224](index=224&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 item is not applicable for the reporting period - Not applicable[242](index=242&type=chunk) [Item 5. Other Information](index=58&type=section&id=Item%205.%20Other%20Information) During the quarter, no directors or officers adopted or terminated any Rule 10b5-1 trading plans or other non-Rule 10b5-1 trading arrangements - No directors or officers adopted or terminated a Rule 10b5-1 trading plan during the fiscal quarter ended June 30, 2025[245](index=245&type=chunk) [Item 6. Exhibits](index=59&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer - The report includes a list of exhibits filed, such as corporate governance documents and officer certifications required by the Sarbanes-Oxley Act[246](index=246&type=chunk)