Core Insights - OS Therapies has been invited to participate in the "Beyond the Cure: The Brave New World of Revolutionary Cancer Therapeutics" Spotlight Panel at BioFuture 2025, highlighting its focus on innovative cancer treatments [1][3] - The company plans to submit a Biologics Licensing Application (BLA) to the FDA in Q4 2025, aiming for approval that could lead to a Priority Review Voucher (PRV) sale to fund further clinical development [2][4] - OS Therapies' lead asset, OST-HER2, is an immunotherapy targeting HER2 protein, showing promising results in clinical trials for osteosarcoma and breast cancer [4][5] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, leveraging a unique listeria monocytogenes platform technology [3][4] - The company has received multiple designations from the FDA, including Rare Pediatric Disease Designation and Fast-Track status for OST-HER2, which has shown statistically significant benefits in clinical trials [4] - OS Therapies is also advancing next-generation Antibody Drug Conjugates (ADCs) and Drug Conjugates (DCs) through its proprietary technology [5][6]

Core Insights - OS Therapies has completed the last patient visit in its Phase 1b clinical trial for OST-504, focusing on biochemically recurrent prostate cancer, with a total of 7 patients enrolled [1][2] - The company is optimistic about the potential of OST-504 in various prostate cancer settings and plans to report study results in Q4 2025 [2] - Prostate cancer represents a significant market opportunity, with 1 in 8 men diagnosed and 1 in 44 men dying from the disease, making it the second leading cause of cancer death among men [2] - The company is also preparing for a rolling submission for a Biologics Licensing Application (BLA) for OST-HER2 in osteosarcoma, which could lead to accelerated market access for OST-504 if successful [2][5] - Updated 2-year overall survival data from the Phase 2b trial of OST-HER2 will be released on October 10, 2025 [4] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, with OST-HER2 as its lead asset [3][5] - OST-HER2 has received multiple designations from the FDA, including Rare Pediatric Disease Designation and Fast-Track status, and has shown positive results in its Phase 2b clinical trial [3][5] - The company is advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [6]

Core Insights - Stonegate Capital Partners has initiated coverage on OS Therapies Inc. (OSTX), highlighting significant clinical, regulatory, and financial advancements in Q2 2025 as the company approaches the launch of OST-HER2 for patients with recurrent, fully resected, pulmonary metastatic osteosarcoma [1][3] Clinical and Regulatory Developments - The FDA has confirmed that OST-HER2 qualifies as a Regenerative Medicine Advanced Therapy (RMAT) and has issued a Biologics License Application (BLA) number in preparation for an Accelerated Approval submission [1][3] - Final 12-month Event Free Survival (EFS) results from the Phase 2b trial showed a statistically significant improvement of 35% compared to 20%, alongside interim 2-year Overall Survival (OS) data of 66.6% versus 40%, indicating strong clinical benefits [5] Financial Position and Partnerships - OS Therapies has secured a U.S. commercial partnership with Eversana, positioning for a potential U.S. launch in the first half of 2026 [1][3] - The company completed warrant exchange financings raising approximately $7.9 million in Q3, extending its cash runway into 2027 and funding preparations for the commercial launch [5]

Core Insights - OS Therapies Inc. is a clinical-stage biotechnology company focused on cancer immunotherapy and antibody drug conjugates, particularly for Osteosarcoma and other solid tumors [1][2] - The company's lead asset, OST-HER2, has shown positive results in a Phase 2b clinical trial for recurrent lung metastatic osteosarcoma, achieving statistically significant benefits in the 12-month event-free survival primary endpoint [1] - OST-HER2 has received multiple designations from the U.S. FDA, including Rare Pediatric Disease Designation, Fast-Track, and Orphan Drug designations, and the company plans to submit a Biologics Licensing Application in 2025 [1] - The company is also developing a next-generation Antibody Drug Conjugate platform known as tunable ADC (tADC), utilizing proprietary technology for enhanced delivery of therapeutic payloads [2] Upcoming Events - OS Therapies will participate in several investor conferences in September 2025, including the Cantor Global Healthcare Conference from September 3-5, H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, and Lake Street Capital Markets 9th Annual Best Ideas Growth Conference on September 11 [5]

Core Viewpoint - OS Therapies is progressing towards the submission of a rolling Biologics Licensing Application (BLA) for its OST-HER2 program targeting recurrent, fully resected, pulmonary metastatic osteosarcoma, following a productive End of Phase 2 meeting with the FDA [1][2][6] Group 1: FDA Meeting Outcomes - The FDA and OS Therapies reached alignment on several critical areas necessary for a successful BLA, including clinical trial efficacy endpoints and statistical analysis plans [2] - A public meeting with key osteosarcoma stakeholders is scheduled for October 10, 2025, to discuss advancing drug development for osteosarcoma [2] - The FDA is committed to working closely with the Company, prioritizing both formal and informal meetings, with the first informal meeting set for mid-September 2025 [2][6] Group 2: Clinical Data and Safety Profile - No significant safety concerns were identified for OST-HER2 based on the clinical data available to date, indicating an excellent safety profile [3] - The Company is preparing necessary data for submission to the FDA as part of the rolling BLA submission expected in Q4 2025 [3] Group 3: Designations and Financial Aspects - OST-HER2 has received Rare Pediatric Disease Designation (RPDD) and is eligible for a Prescription Drug User Fee Act (PDUFA) small business fee waiver, with a decision expected by the end of Q3 2025 [5][7] - The Company anticipates significant progress towards Breakthrough Therapy designation (BTD) and either Accelerated Approval or full approval during the upcoming FDA/OSI workshop [4] Group 4: Future Developments - OS Therapies is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced treatment delivery [8] - The Company is actively compiling data for the OST-400 natural history database to support the development of a synthetic control arm for future trials [2][6]

Core Insights - OS Therapies has completed a warrant inducement and exchange offer, raising approximately $3.7 million in gross proceeds to accelerate preparations for the commercial launch of OST-HER2 [1][4] - The company aims to bring OST-HER2 to market in early 2026, pending FDA regulatory approval [2] - New warrants have been issued with an exercise price of $3.00 per share, which includes a forced exercise provision when the stock trades above $9.00, potentially bringing in over $20 million in additional funding [2][4] Financial Details - The warrant exchange raised approximately $3.7 million, which will primarily be used for commercial preparations related to OST-HER2 [1][4] - The forced exercise provision of the new warrants could lead to over $20 million in additional funding if triggered [2] Product Development - OST-HER2 is the lead asset of OS Therapies, targeting osteosarcoma and has received multiple designations from the FDA, including Rare Pediatric Disease Designation [3][5] - The company plans to submit a Biologics Licensing Application (BLA) for OST-HER2 in 2025, which could lead to a Priority Review Voucher if approved [5] - OS Therapies is also advancing its next-generation Antibody Drug Conjugate (ADC) technology, known as tunable ADC (tADC) [6]

Core Viewpoint - OS Therapies has terminated its Equity Purchase Agreement with Square Gate Capital Master Fund, effective August 26, 2025, and has successfully raised $4.2 million through a warrant exercise inducement and exchange offering to fund operations into mid-2026 [1][2]. Group 1: Financial Developments - The termination of the Equity Purchase Agreement (ELOC) with Square Gate Capital Master Fund is effective August 26, 2025 [1]. - The company raised $4.2 million in gross proceeds from a recent warrant exercise inducement and exchange offering, which will support operations through mid-2026 [2]. Group 2: Clinical Trials and Product Development - The treatment phases of the Phase 2b OST-HER2 clinical trial in osteosarcoma and the Phase 1b OST-504 clinical trial in prostate cancer are now complete, leading to a projected monthly burn rate in the second half of 2025 that is significantly lower than in the first half [3]. - OS Therapies plans to allocate capital primarily to drive towards approval for OST-HER2 in osteosarcoma while analyzing data from OST-504 for future development steps [3]. Group 3: Company Overview and Product Pipeline - OS Therapies is focused on developing treatments for osteosarcoma and other solid tumors, with its lead asset, OST-HER2, leveraging immune-stimulatory effects to target the HER2 protein [4]. - OST-HER2 has received multiple designations from the U.S. FDA, including Rare Pediatric Disease Designation and Fast-Track designation, and the company plans to submit a Biologics Licensing Application (BLA) for OST-HER2 in 2025 [4]. - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced delivery of therapeutic payloads [5].

[OS Therapies Q2 2025 Financial Results and Business Update](index=1&type=section&id=OS%20Therapies%20Q2%202025%20Financial%20Results%20and%20Business%20Update) [Business Update and Strategic Outlook](index=1&type=section&id=Business%20Update%20and%20Strategic%20Outlook) The company reports positive clinical data and regulatory progress for its lead candidate OST-HER2, advancing towards a BLA submission and a potential 2026 launch - Updated interim 2-year overall survival and final 12-month Event Free Survival (EFS) data both show a **statistically significant benefit** for patients treated with OST-HER2[3](index=3&type=chunk) - The company is progressing towards a **Biologics Licensing Application (BLA) submission** to the U.S. FDA for OST-HER2 under the Accelerated Approval Program[3](index=3&type=chunk) - A commercial partnership with Eversana is in place, preparing for a potential **U.S. launch of OST-HER2 in the first half of 2026**[3](index=3&type=chunk) - The company is eligible for a Priority Review Voucher (PRV) upon BLA approval, which it intends to sell; recent PRV sales were valued between **$155 million and $160 million**[3](index=3&type=chunk) - Regulatory processes have been initiated internationally, with an ILAP submission to the U.K's MHRA and a scheduled meeting with the European Medicines Agency (EMA)[3](index=3&type=chunk) [Key Corporate Highlights](index=1&type=section&id=Key%20Corporate%20Highlights) The company highlights positive FDA interactions, strong clinical data, a commercial partnership, a successful capital raise, and inclusion in Russell indexes - The FDA confirmed OST-HER2 meets the biological definition of a **Regenerative Medicine Advanced Therapy (RMAT)** and issued a BLA number in preparation for submission[4](index=4&type=chunk) - **Statistically significant** 12-month Event Free Survival and interim 2-year Overall Survival data are driving global accelerated approval pathways[4](index=4&type=chunk) - A commercial partnership with Eversana positions OST-HER2 for a potential **U.S. launch in the first half of 2026**[4](index=4&type=chunk) - A **$4.2 million capital raise**, closed in July 2025, extends the company's cash runway into mid-2026[4](index=4&type=chunk) - The company's stock (OSTX) was included in the **Russell Microcap, Russell Microcap Value, and Russell Microcap Growth indexes**[4](index=4&type=chunk) [Detailed Progress and Upcoming Milestones](index=2&type=section&id=Detailed%20Progress%20and%20Upcoming%20Milestones) The company outlines significant clinical, regulatory, and corporate achievements and key milestones for the remainder of 2025 [Progress to Date](index=2&type=section&id=Progress%20to%20Date) The company details positive clinical data, regulatory progress in the US and Europe, and key corporate developments including a capital raise and partnership **OST-HER2 Phase 2b Clinical Trial Data** | Metric | OST-HER2 vs. Control | P-value | | :--- | :--- | :--- | | **Final 12-month EFS** | 35% vs. 20% | p = 0.0197 | | **Interim 2-year Overall Survival** | 66.6% vs. 40% | p = 0.0046 | - OST-HER2 demonstrated a **strong safety profile**, with zero patients experiencing grade 4 or grade 5 treatment-associated adverse events[5](index=5&type=chunk) - Acquired the listeria cancer immunotherapy platform from Ayala Pharmaceuticals, adding **4 clinical-stage and 8 preclinical-stage candidates** to the pipeline[5](index=5&type=chunk) - Closed a warrant exercise inducement and exchange offering, raising **$4.2 million in gross proceeds** and extending the cash runway into mid-2026[5](index=5&type=chunk) [Upcoming 2025 Milestones](index=3&type=section&id=Upcoming%202025%20Milestones) Key upcoming milestones include FDA and EMA meetings and the initiation of a rolling BLA submission for OST-HER2 - An **End of Phase 2 Meeting with the FDA** is scheduled for August 27, 2025, to guide the BLA submission process[9](index=9&type=chunk) - The company projects initiating a **rolling BLA submission** for OST-HER2 in late Q3 2025[9](index=9&type=chunk) - A rapporteur meeting with the EMA is scheduled for October 2025 to advance the **European approval process**[9](index=9&type=chunk) - The company is targeting potential **regulatory approval for OST-HER2 in the U.S. and U.K.** as early as year-end 2025[9](index=9&type=chunk) - An At-The-Market (ATM) offering agreement was established, enabling the company to raise up to **$18 million in gross proceeds**[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reports a higher net operating loss due to increased regulatory expenses, though net loss per share improved with more shares outstanding **Q2 2025 vs. Q2 2024 Financials** | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | **Net Operating Loss** | $4.537 million | $1.557 million | | **Net Loss Per Share** | $0.19 | $0.26 | | **Weighted Avg. Shares** | 25.114 million | 5.991 million | - The increase in net operating loss was largely due to expenses associated with U.S. and international **regulatory activities** for the OST-HER2 Phase 2b osteosarcoma program[6](index=6&type=chunk) [Company Overview](index=3&type=section&id=Company%20Overview) The company is a clinical-stage oncology firm focused on Osteosarcoma, with a lead immunotherapy candidate, OST-HER2, and a tADC platform - The company's lead asset is **OST-HER2**, an immunotherapy for Osteosarcoma that targets the HER2 protein[7](index=7&type=chunk) - OST-HER2 has received **Rare Pediatric Disease Designation (RPDD), Fast-Track, and Orphan Drug designations** from the U.S. FDA and EMA[7](index=7&type=chunk) - The company is also advancing a next-generation tunable **Antibody Drug Conjugate (tADC) platform** using proprietary Si-Linker and Conditionally Active Payload (CAP) technology[8](index=8&type=chunk)

Core Viewpoint - OS Therapies reported significant clinical and regulatory progress in the second quarter of 2025, particularly regarding its lead asset OST-HER2 for treating osteosarcoma, with plans for a Biologics Licensing Application (BLA) submission by the end of 2025 [4][12]. Financial Results - The company recorded a net operating loss of $4.537 million in Q2 2025, compared to a loss of $1.557 million in Q2 2024, primarily due to regulatory expenses related to the OST-HER2 program [8]. - Net loss per share was $0.19 on 25.114 million weighted average shares outstanding in Q2 2025, compared to a loss of $0.26 per share on 5.991 million shares in Q2 2024 [8]. Clinical and Regulatory Updates - Updated interim data from the Phase 2b trial showed a statistically significant overall survival rate of 66.6% for OST-HER2 treated patients compared to 40% for controls (p = 0.0046) [7]. - The final 12-month Event Free Survival (EFS) data indicated a benefit of 35% for OST-HER2 treated patients versus 20% for historical controls (p = 0.0197) [7]. - The FDA confirmed that OST-HER2 meets the biological definition of Regenerative Medicine Advanced Therapy (RMAT) and issued a BLA number in preparation for the Accelerated Approval submission [5][6]. Strategic Partnerships and Market Position - The company has established a U.S. commercial partnership with Eversana, positioning OST-HER2 for a potential launch in the first half of 2026 [5][6]. - OS Therapies raised $4.2 million through a warrant exercise inducement and exchange offering, extending its cash runway into mid-2026 [5][6]. International Expansion - The company submitted an Innovative Licensing and Access Pathway (ILAP) request to the UK's MHRA and plans to synchronize the approval process with the FDA via Project Orbis [4][6]. - A rapporteur meeting with the European Medicines Agency (EMA) is scheduled for October 2025 to initiate the regulatory approval process in Europe [6][12]. Pipeline and Future Prospects - OS Therapies completed the acquisition of a listeria cancer immunotherapy platform, expanding its pipeline with four clinical-stage and eight preclinical-stage candidates [7]. - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC) [10].

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section details the company's unaudited financial statements, management's financial analysis, market risk, and internal controls [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements.) This section presents the unaudited consolidated financial statements, including balance sheets, operations, equity, and cash flows, highlighting increased net loss, asset growth, and liquidity concerns [Balance Sheets](index=3&type=section&id=Balance%20Sheets) The balance sheets show significant asset growth driven by patent acquisition and a shift from stockholders' deficit to positive equity Balance Sheet Summary (unaudited) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $2,802,013 | $5,533,527 | | Total Current Assets | $3,553,976 | $5,533,527 | | Patents (Net) | $6,752,619 | $0 | | **Total Assets** | **$10,310,475** | **$5,538,797** | | **Liabilities & Equity** | | | | Total Current Liabilities | $3,458,034 | $4,627,310 | | Total Liabilities | $3,558,034 | $4,727,310 | | Total Stockholders' Equity (Deficit) | $4,943,647 | ($3,266,538) | - Total assets increased significantly from **$5.5 million** to **$10.3 million**, primarily driven by the acquisition of patents valued at **$6.8 million**[9](index=9&type=chunk) - The company's financial position improved from a stockholders' deficit of **($3.3 million)** at the end of 2024 to a positive stockholders' equity of **$4.9 million** as of June 30, 2025[9](index=9&type=chunk) [Statements of Operations](index=4&type=section&id=Statements%20of%20Operations) The statements of operations reveal a substantial increase in net loss due to higher research and development and general and administrative expenses Statements of Operations Summary (unaudited) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $2,499,498 | $396,567 | $3,808,653 | $758,376 | | General & Administrative | $2,339,230 | $383,233 | $6,029,561 | $651,656 | | Loss from Operations | ($4,838,728) | ($779,800) | ($9,838,214) | ($1,410,032) | | **Net Loss** | **($4,536,622)** | **($1,557,480)** | **($8,413,481)** | **($3,016,472)** | | Basic & Diluted Loss per Share | ($0.19) | ($0.26) | ($0.35) | ($0.52) | - Net loss for the six months ended June 30, 2025, increased to **$8.4 million** from **$3.0 million** in the same period of 2024, driven by a substantial rise in both Research & Development and General & Administrative expenses[11](index=11&type=chunk) [Statements of Stockholders' Equity (Deficit)](index=5&type=section&id=Statements%20of%20Stockholders%27%20Equity%20%28Deficit%29) This section details the increase in common shares outstanding and the drivers of the shift to positive stockholders' equity, including conversions and stock issuances - The number of common shares issued and outstanding increased from **20.9 million** at the end of 2024 to **29.7 million** by June 30, 2025[14](index=14&type=chunk) - The increase in stockholders' equity during the first half of 2025 was driven by several non-cash and financing activities, including the conversion of preferred shares and warrants to common stock, and issuance of common stock for a patent purchase and services[14](index=14&type=chunk) [Statements of Cash Flows](index=6&type=section&id=Statements%20of%20Cash%20Flows) The cash flow statements show a significant increase in cash used in operating activities, partially offset by cash provided from financing activities Cash Flow Summary (unaudited) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($5,802,138) | ($1,522,920) | | Net cash used in investing activities | ($466,423) | $0 | | Net cash provided by financing activities | $3,537,047 | $1,578,863 | | **Net change in cash** | **($2,731,514)** | **$55,943** | | Cash – end of period | $2,802,013 | $94,925 | - Cash used in operating activities significantly increased to **$5.8 million** in the first six months of 2025, compared to **$1.5 million** in the prior year period, reflecting the higher net loss[17](index=17&type=chunk) - Financing activities provided **$3.5 million** in cash, primarily from the sale of preferred stock and warrant conversions, which partially offset the cash used in operations and investing[17](index=17&type=chunk) [Notes to the Financial Statements](index=7&type=section&id=Notes%20to%20the%20Financial%20Statements) These notes detail critical accounting policies, significant transactions like the HER2 asset acquisition, debt conversions, and the company's going concern assessment - The company's financial statements are prepared on a going concern basis, but its history of net losses and negative operating cash flows raises substantial doubt about its ability to continue as a going concern. As of June 30, 2025, the company had cash of **$2.8 million** and is dependent on raising additional capital[22](index=22&type=chunk)[23](index=23&type=chunk) - On April 9, 2025, the company acquired HER2 Assets from Ayala Pharmaceuticals for a total fair value of **$6,864,438**, consisting of cash and common stock. This is accounted for as an asset acquisition[33](index=33&type=chunk)[34](index=34&type=chunk) - All convertible notes were converted into common stock on August 2, 2024, upon the consummation of the company's IPO, resulting in a zero balance for convertible debt as of June 30, 2025[75](index=75&type=chunk)[80](index=80&type=chunk) - Subsequent to the quarter end, the company issued an aggregate of **1,621,060 shares** of common stock upon the exercise of Series A Warrants and filed a registration statement on Form S-3 for a potential offering of up to **$100 million** in securities[189](index=189&type=chunk)[190](index=190&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=38&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses the company's clinical-stage biopharmaceutical focus, recent financing activities, significant increases in operating expenses leading to higher net loss, and ongoing liquidity challenges requiring additional capital - The company is a clinical-stage biopharmaceutical firm focused on treatments for Osteosarcoma (OS), with its lead product candidate being OST-HER2. A clinical study for OST-HER2 achieved full enrollment in October 2023, and the company plans to submit a Biologics License Application (BLA) following an anticipated End of Phase 2 meeting with the FDA in Q3 2025[196](index=196&type=chunk) - Recent financing activities include a PIPE financing in late 2024/early 2025 raising gross proceeds of **~$7.1 million** and a warrant exercise inducement offer completed in July 2025 raising gross proceeds of **~$4.2 million**[198](index=198&type=chunk)[207](index=207&type=chunk)[210](index=210&type=chunk) - On April 9, 2025, the company acquired Lm-based immune-oncology programs and related intellectual property assets (the "HER2 Assets") from Ayala Pharmaceuticals, Inc[203](index=203&type=chunk) Comparison of Operating Results (Six Months Ended June 30) | Expense Category | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research & Development | ~$3.8 million | ~$0.8 million | +$3.0 million | | General & Administrative | ~$6.0 million | ~$0.7 million | +$5.3 million | | **Net Loss** | **~$8.4 million** | **~$3.0 million** | **+$5.4 million** | - As of June 30, 2025, the company had approximately **$2.8 million** in cash. Management believes this, along with proceeds from recent financing, will fund operations and capital requirements for the next 9 to 12 months[241](index=241&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=55&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) The company, as a smaller reporting company, has indicated that this section is not applicable and has not provided any disclosures regarding market risk - This section is marked as 'Not applicable', which is common for smaller reporting companies[279](index=279&type=chunk) [Item 4. Controls and Procedures](index=55&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that the company's disclosure controls and procedures were ineffective as of June 30, 2025, due to limited personnel and insufficient policies, with no material changes to internal controls during the quarter - Management concluded that as of June 30, 2025, the company's disclosure controls and procedures were not effective[281](index=281&type=chunk) - The identified weakness is a lack of segregation of duties due to limited personnel and insufficient written policies for accounting, IT, and financial reporting[281](index=281&type=chunk) [PART II. OTHER INFORMATION](index=56&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional information including legal proceedings, updated risk factors, unregistered sales of equity securities, and a list of exhibits [Item 1. Legal Proceedings](index=56&type=section&id=Item%201.%20Legal%20Proceedings.) The company reports no pending legal proceedings, though an arbitration claim from a former investment advisor regarding IPO compensation is disclosed in Note 6 - The company is not currently a party to any pending legal proceedings[284](index=284&type=chunk) - Note 6 to the financial statements discloses an arbitration claim brought by a former investment advisor regarding underwriter compensation for the IPO, which the company believes is meritless[159](index=159&type=chunk)[284](index=284&type=chunk) [Item 1A. Risk Factors](index=56&type=section&id=Item%201A.%20Risk%20Factors.) This section references existing risk factors and introduces a new one concerning the potential adverse impact on common stock price from the issuance and resale of shares related to a recent warrant inducement offering - A new risk factor has been added concerning the potential for the market price of common stock to be adversely affected by the issuance of **3,764,995 shares** in connection with the recent warrant inducement offering and the potential resale of these shares[286](index=286&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=56&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) In Q2 2025, the company issued **10,000 shares** of common stock to an advisor for services, relying on a Section 4(a)(2) Securities Act registration exemption - In Q2 2025, the company issued **10,000 shares** of common stock to an advisor for services, exempt from registration under Section 4(a)(2) of the Securities Act[288](index=288&type=chunk) [Item 6. Exhibits](index=57&type=section&id=Item%206.%20Exhibits.) This section lists all exhibits filed with the Form 10-Q, including warrant and inducement offer forms, and required CEO/CFO certifications - The report includes several exhibits, notably the Form of Warrant and Form of Inducement Offer Letter from the June 2025 financing activities, and CEO/CFO certifications as required by the Sarbanes-Oxley Act[289](index=289&type=chunk)