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Tivic Health Systems(TIVC) - 2025 Q3 - Quarterly Report
2025-11-14 21:34
Product Development and Regulatory Approvals - Tivic Health's lead product candidate, Entolimod™, is in late-stage development for treating acute radiation syndrome (ARS) and has received Fast Track and Orphan Drug designations from the FDA[183]. - Tivic Health has invested over $140 million in Entolimod and Entolasta, including $35.6 million from various government agencies, and plans to initiate Phase 2 clinical studies for oncology-related indications[188]. - The company plans to validate the manufacturing process for Entolimod to submit a biologics license application (BLA) to the FDA, which is crucial for marketing the product in the U.S.[189]. - The FDA has granted Entolimod designations to mitigate the likelihood of death following a potential lethal dose of total body ionization during radiation disasters[188]. - The company plans to increase investments in manufacturing and regulatory processes for product candidates Entolimod and Entolasta as it prepares to seek a Biologics License Application (BLA) from the FDA[229]. Financial Performance and Revenue - For the three months ended September 30, 2025, revenue increased by $20 thousand, or 16%, compared to the same period in 2024, primarily due to a 40% increase in the number of units sold[206]. - For the nine months ended September 30, 2025, revenue decreased by $298 thousand, or 50%, compared to the same period in 2024, primarily due to a 45% decrease in the number of units sold[207]. - The company expects revenues to decrease significantly as it plans to exit the consumer business by the end of the year[208]. - Cash used in operating activities for the nine months ended September 30, 2025, was $4.7 million, primarily due to a net loss of $6.0 million, offset by non-cash charges of $857 thousand[244]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $6.7 million, including proceeds from the sale of common stock and Series B Preferred Stock[247]. Expenses and Financial Challenges - Cost of sales for the three months ended September 30, 2025, increased by $209 thousand, or 255%, compared to the same period in 2024, primarily due to a $230 thousand inventory reserve for excess and obsolete inventory[210]. - Research and development expenses increased by $436 thousand for the three months ended September 30, 2025, and by $868 thousand for the nine months ended September 30, 2025, primarily due to the addition of the biopharma program[215]. - General and administrative expenses increased by $246 thousand for the three months ended September 30, 2025, and by $521 thousand for the nine months ended September 30, 2025, driven by increased employee-related costs and legal fees[220][221]. - The company incurred an accumulated deficit of $49.6 million through September 30, 2025, and expects to continue incurring losses in the future as it expands research and development activities[236]. - The company anticipates that its cash and financial resources may be insufficient to meet anticipated needs for the next twelve months, raising substantial doubt about its ability to continue as a going concern[236]. Strategic Changes and Business Focus - The company has shifted focus from its consumer health business to advancing its biologic pipeline, leading to the discontinuation of the ClearUP device by year-end[184][186]. - The company plans to wind down its consumer health business, which is expected to lead to a decline in revenue until regulatory approval is obtained for new product candidates[230]. - The company may consider strategic acquisitions or licensing opportunities that align with its growth plan, which could require a substantial portion of its cash reserves[235]. Operational and Market Conditions - The ongoing geopolitical conflicts, including those in Ukraine and Israel, have led to increased economic uncertainty and volatility in capital markets, potentially impacting the company's operations[249][255][256]. - Supply chain disruptions in 2022 resulted in increased inventory balances, with material reserves expected in 2024 and 2025 due to ongoing shortages and financial stress of contract manufacturers[250][251]. - Inflation has significantly increased in 2024, affecting costs related to products, interest rates, and transportation, which may impact future operating results[259]. - The recent prolonged shutdown of the U.S. federal government has created challenges in forecasting future revenues and financial results due to increased economic volatility[257]. - The company is considering alternative contract manufacturers due to the financial instability of its current contract manufacturer, which may affect production timelines[268]. Agreements and Funding - The company has entered into an Equity Purchase Agreement allowing it to sell up to $25 million in common stock over 24 months, with gross proceeds of $783 thousand from 235,792 shares sold as of September 30, 2025[195]. - A Preferred Purchase Agreement has been established for the sale of up to 8,400 shares of Series B Non-Voting Convertible Preferred Stock, generating gross proceeds of $4.9 million from four tranche closings[196]. - The company closed multiple tranches of funding under the Preferred Purchase Agreement, raising a total of $8.4 million, with net proceeds from various tranches totaling approximately $4.8 million[226]. Miscellaneous - The company has not entered into any off-balance sheet arrangements, maintaining a straightforward financial structure[260]. - Significant accounting policies and estimates are detailed in Note 2 of the condensed financial statements[271]. - Recent accounting pronouncements are also described in Note 2 of the condensed financial statements[272]. - There are no applicable quantitative and qualitative disclosures about market risk[273].
Tivic Health Systems(TIVC) - 2025 Q3 - Quarterly Results
2025-11-14 21:31
Financial Performance - Revenue for Q3 2025 totaled $146,000, a 15.9% increase from $126,000 in Q3 2024[6] - Gross loss for Q3 2025 was $145,000, compared to a gross profit of $44,000 in Q3 2024, primarily due to $230,000 in inventory reserves[6] - Operating expenses increased to $2.3 million in Q3 2025 from $1.5 million in Q3 2024, attributed to the addition of the biopharma business and increased corporate costs[6] - Net loss for Q3 2025 was $2.6 million, compared to a net loss of $1.4 million in Q3 2024[9] - Tivic's gross margin, excluding inventory reserves, was 42% in Q3 2025, compared to 35% in Q3 2024[6] Cash Position - Cash and cash equivalents as of September 30, 2025, were $3.5 million, up from $2.0 million at December 31, 2024[9] Business Development - Tivic completed the transfer of two INDs from Statera Biopharma, enabling clinical trials for Entolimod in neutropenia and cancer-related conditions[6] - The company successfully completed cell line verification, a key step for cGMP manufacturing, necessary for filing a biologics license application with the FDA[6] - The company executed the write-down of ClearUP inventory, resulting in $230,000 of cost of goods sold and $117,000 of other expenses[9] - The company is advancing discussions for deploying Entolimod as a military countermeasure and stockpile drug[6]
Tivic Reports Third Quarter 2025 Financial Results
Accessnewswire· 2025-11-14 21:30
Core Insights - Tivic Health® Systems, Inc. is advancing its strategic transformation and biologics pipeline, focusing on its lead product candidate, Entolimod, for acute radiation syndrome (ARS) [1] Financial Results - The company announced financial results for the third quarter and nine months ended September 30, 2025 [1] Business Update - Engagement with key government agencies has generated interest in Entolimod as a military medical countermeasure and stockpile drug [1]
Tivic Health Reports Findings of Clinical Optimization Trial of Non-Invasive Cervical Vagus Nerve Stimulation (ncVNS)
Accessnewswire· 2025-11-13 13:30
Core Insights - Tivic Health Systems, Inc. has optimized key device and treatment parameters for ncVNS, enhancing its effectiveness through personalization [1] Company Developments - The company collaborated with The Feinstein Institutes for Medical Research at Northwell Health to conduct a study on ncVNS treatment [1] - Key parameters optimized include frequency, amplitude, electrode positioning, and duration of stimulation [1] Study Findings - Personalizing the frequency of ncVNS stimulation led to a 46% increase in heart rate variability, which was 8.9 times more effective than using a uniform frequency across all subjects [1] - The optimal ncVNS frequency varied between subjects and visits, highlighting the need for personalized stimulation parameters before each treatment [1] - Certain electrode placements and configurations were found to significantly impact heart rate variability, with some placements increasing it while others decreased it [1] - A duration of four minutes of ncVNS stimulation was sufficient to achieve a substantial increase in heart rate variability, proving more effective than twenty minutes of stimulation [1]
Tivic Health to Report Third Quarter 2025 Financial Results on November 14th Via Conference Call and Webcast
Businesswire· 2025-11-06 14:30
Core Viewpoint - Tivic Health Systems, Inc. will report its third quarter financial results for 2025 on November 14, 2025, via a pre-recorded conference call and webcast [1]. Company Overview - Tivic Health is a diversified immunotherapeutics company that utilizes both biopharmaceutical and bioelectronic systems to address unmet medical needs by targeting the immune system [2][3]. - The company's lead drug candidate, Entolimod™, is a novel TLR5 agonist aimed at treating acute radiation syndrome and has received Fast Track and Orphan Drug designations, currently in late-stage development [3]. Product Development - Tivic's biologics compounds are designed to activate an innate immune pathway to prevent cell death in bone marrow and epithelial tissues affected by radiation and aging [3]. - The bioelectronic program is focused on developing a non-invasive medical device targeting neural pathways associated with various prevalent diseases, showing promising early trial results [4]. Upcoming Events - CEO Jennifer Ernst will participate in the 8th Annual Northwell Health Innovation Constellation Forum on October 23, discussing advancements in bioelectronic medicine [8]. - Jennifer Ernst will also present at the Emerging Growth virtual conference on September 25, 2025, detailing the company's strategic transformation [9]. Manufacturing Progress - Tivic has completed the verification of its Entolimod™ cell line, marking the first step towards establishing Current Good Manufacturing Practices (CGMP) in preparation for a Biologics License Application (BLA) [10][11].
Tivic CEO, Jennifer Ernst, to Join Panel at 8th Annual Northwell Health Innovation Constellation Forum on Thursday, Oct. 23
Businesswire· 2025-10-22 18:00
Core Insights - Tivic Health Systems, Inc. is participating in the eighth annual Northwell Health Innovation Constellation Forum, focusing on bioelectronic medicine and its potential to transform healthcare delivery [1][4] - CEO Jennifer Ernst will join a panel to discuss collaboration across the healthcare ecosystem to drive the adoption of bioelectronic medicine [2][3] Company Overview - Tivic Health is a diversified immunotherapeutics company utilizing both biopharmaceutical and bioelectronic systems to address unmet medical needs by targeting the immune system [5] - The company's lead drug candidate, Entolimod™, is in late-stage development for acute radiation syndrome and has received Fast Track and Orphan Drug designations [6] Industry Context - Bioelectronic medicine is positioned as a transformative frontier that integrates science, technology, and patient care, with the potential to disrupt traditional disease management [2][4] - The upcoming program at the Constellation Forum will highlight breakthroughs, commercialization strategies, and challenges in scaling bioelectronic medicine into everyday healthcare [4]
Tivic Health Systems (NasdaqCM:TIVC) 2025 Conference Transcript
2025-09-25 16:27
Tivic Health Systems Conference Summary Company Overview - **Company**: Tivic Health Systems (NasdaqCM:TIVC) - **Focus**: Development of non-invasive medical devices targeting neural pathways and a strong late-stage pipeline in biopharmaceuticals, particularly in immunomodulation and cancer therapeutics [1][2] Key Points Transformation and Pipeline Development - Tivic Health has undergone a significant transformation by acquiring newly licensed assets, leading to a robust late-stage portfolio in biopharmaceuticals [2] - The company maintains a clean capital structure with no debt and anticipates significant value inflection points in the near future [2] Biopharmaceutical Focus - The company is focusing on immunomodulation, utilizing the immune system to combat diseases and improve health outcomes [3] - A biologic licensing agreement was established, including a phase three recombinant protein funded by BARDA for radiation countermeasures, with potential applications in cancer [3][4] Entolimod and Market Opportunities - **Entolimod**: A TLR5 agonist with dual capabilities to treat acute radiation syndrome and cancer-related conditions, showing a 300% increase in survival rates with a single dose [9][23] - The market for GCSF drugs, which Entolimod aims to compete against, is valued at approximately $7.2 billion in 2023, with a broader neutropenia market of around $20 billion [9][31] - Entolimod is positioned as a military countermeasure for nuclear disasters, with a potential market opportunity of $5.2 billion for stockpiling [9][10] Clinical and Regulatory Progress - The company has made significant strides in customer engagement and manufacturing agreements, moving towards a Biologics License Application (BLA) filing [5][10] - The FDA has granted fast track and orphan drug designations for Entolimod, facilitating expedited regulatory processes [11] Future Directions and Strategic Focus - The company plans to focus on Entolimod over the next 6 to 18 months while also exploring other high-potential areas, including cancer therapeutics and vagus nerve stimulation technologies [17][35] - By 2026, Tivic Health aims to have GMP materials ready, FDA meetings completed, and customer interest solidified [34] Additional Insights - The company operates with a capital-light model and has a strong team with extensive experience in drug launches and biopharmaceutical development [16][25] - There is potential for partnerships with larger organizations to scale production and market reach effectively [29] - The vagus nerve technology remains a promising area for future development, with established research backing its efficacy [13][12] Conclusion Tivic Health Systems is positioned for growth with its innovative biopharmaceutical pipeline, particularly through Entolimod, which addresses significant market needs in radiation countermeasures and cancer therapeutics. The company's strategic focus on regulatory pathways and partnerships will be crucial for its success in the coming years.
Tivic Health Systems(TIVC) - 2025 Q2 - Earnings Call Transcript
2025-08-14 21:30
Financial Data and Key Metrics Changes - Revenue net of returns totaled $86,000 for Q2 2025 compared to $140,000 in Q2 2024, and $156,000 for the first half of 2025 compared to $474,000 for the first half of 2024, reflecting a significant decline due to decreased unit sales of ClearUp [16][17] - Cost of sales decreased to $32,000 from $110,000 in the year-ago quarter, and gross margins increased to 63% for Q2 2025 compared to 21% a year ago, driven by reductions in product support and fulfillment costs [17][18] - Net loss was $1,900,000 for Q2 2025 compared with $1,300,000 for Q2 2024, and $3,400,000 for the first half of 2025 compared with $2,700,000 for the first half of 2024 [18][19] Business Line Data and Key Metrics Changes - The decline in revenue was primarily due to reduced unit sales of ClearUp, as the company intentionally decreased marketing expenditures to focus on advancing its TLR5 program [17] - Operating expenses increased to $2,000,000 for Q2 2025 compared with $1,300,000 for Q2 2024, mainly due to increased research and development investments in the biologics program [18] Market Data and Key Metrics Changes - The market for neutropenia drugs is projected to be between $19 billion to $24 billion over the next few years, with entolimod potentially addressing a significant portion of this market [10] Company Strategy and Development Direction - The company is transitioning towards the biopharmaceutical market and away from the consumer device market, planning to exit the consumer health tech business by year-end [14] - The exclusive licensing of Sotero Biopharma's TLR5 portfolio is expected to provide a late-stage, highly derisked drug candidate, with significant sales potential from government contracts for acute radiation syndrome (ARS) treatments [4][5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of entolimod and its derivatives to treat radiation and chemotherapy side effects, emphasizing the importance of their strategic pipeline [11][12] - The company is focused on advancing its clinical and commercial opportunities, with key milestones including the transfer of existing INDs and validation of GMP materials [22][23] Other Important Information - The company raised gross proceeds of $900,000 through equity financing, which will support progress towards GMP manufacturing validation for entolimod [19] - Management highlighted the importance of talent acquisition to support clinical work and government relations, indicating a strategic alignment with their new focus [21] Q&A Session Summary - No specific questions and answers were provided in the content, thus this section is not applicable.
Tivic Health (TIVC) Q2 2025 Earnings Transcript
The Motley Fool· 2025-08-14 21:02
Financial Performance - Revenue net of returns was $86,000 for the quarter, down from $140,000 in the prior year, and $156,000 for the first half of 2025 compared to $474,000 for 2024, attributed to decreased unit sales of ClearUp due to reduced marketing expenditures [24][25] - Gross margin increased to 63% for the second quarter, up from 21% a year ago, and 67% from 42% for the first half of 2025 compared to 2024, driven by reduced product support and fulfillment costs [25][26] - Operating expenses rose to $2.0 million for the second quarter from $1.3 million in the prior year, primarily due to increased research and biologics investment, while net loss was $1.9 million compared to $1.3 million in the prior year [3][26] Strategic Shift - The company plans to exit the consumer health technology business and focus exclusively on prescription-based therapeutics, citing underperformance in ClearUp sales [5][22] - An exclusive license was obtained for Sotero Biopharma's TLR5 agonist portfolio, including entolimod, which is seen as a potential growth engine with significant U.S. government contract opportunities for Acute Radiation Syndrome (ARS) [5][8] - Management is pursuing regulatory progress for entolimod, which has received fast track designation and orphan drug status, with a type B FDA meeting planned to advance a Biologic License Application (BLA) filing [5][15] Clinical Development and Manufacturing - GMP manufacturing validation for entolimod has been initiated with Scorpius Biomanufacturing, moving towards key biologics license application steps [6][16] - The company completed all study visits in an optimization study for the noninvasive cervical vagus nerve stimulation (NCVNS) device, with results expected later this year [6][21] - The potential market for neutropenia drugs is estimated between $19 billion to $24 billion, with entolimod positioned to address this market by preventing cell death during radiation treatment [17][18] Leadership and Talent Acquisition - Lisa Wolf has been confirmed as CFO, with key hires from Statera to support regulatory, clinical, and business development efforts [7][28] - The company has made significant adjustments to its staff to align with the new strategic focus, including the transition of the chief scientific officer to a consultancy role [7][28] Future Outlook - The company anticipates completing the transfer of existing INDs from Statera, cell line verification, and the first batch of GMP materials, along with reporting on the VNS trial results [30] - Management emphasizes the importance of the entolimod opportunity, with a single contract for ARS potentially totaling several hundred million dollars [9][13]
Tivic Health Systems(TIVC) - 2025 Q2 - Quarterly Report
2025-08-14 20:32
[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents unaudited condensed financial statements for Q2 2025 and 2024, including balance sheets, statements of operations, equity, and cash flows, detailing accounting policies, immunotherapeutics diversification, financing, and going concern uncertainty [Condensed Financial Statements](index=4&type=section&id=Condensed%20Financial%20Statements) Balance Sheets (in thousands) | Metric | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :--- | :--- | :--- | | Cash and cash equivalents | $1,184 thousand | $2,002 thousand | | Total current assets | $1,842 thousand | $2,639 thousand | | Licensed technology | $2,243 thousand | $0 | | **Total assets** | **$4,508 thousand** | **$2,807 thousand** | | Total current liabilities | $821 thousand | $272 thousand | | **Total liabilities** | **$821 thousand** | **$272 thousand** | | **Total stockholders' equity** | **$3,687 thousand** | **$2,535 thousand** | Statements of Operations (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 | $86 thousand | $140 thousand | $156 thousand | $474 thousand | | Gross profit | $54 thousand | $30 thousand | $104 thousand | $197 thousand | | Total operating expenses | $1,988 thousand | $1,296 thousand | $3,544 thousand | $2,944 thousand | | **Net loss** | **($1,931) thousand** | **($1,266) thousand** | **($3,433) thousand** | **($2,747) thousand** | | Net loss per share | ($2.19) | ($5.37) | ($4.64) | ($17.05) | Statements of Cash Flows (in thousands) | Cash Flow Activity (Six Months Ended June 30) | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($2,716) thousand | ($2,953) thousand | | Net cash used in investing activities | ($546) thousand | $0 | | Net cash provided by financing activities | $2,444 thousand | $3,251 thousand | | **Net (decrease) increase in cash** | **($818) thousand** | **$298 thousand** | | **Cash at end of period** | **$1,184 thousand** | **$3,693 thousand** | [Notes to Unaudited Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) - The company diversified into immunotherapeutics by licensing Entolimod™ from Statera Biopharma for Acute Radiation Syndrome (ARS) and neutropenia[18](index=18&type=chunk)[85](index=85&type=chunk) - The company's **$3.4 million net loss** for H1 2025, **$47.0 million accumulated deficit**, and **$1.2 million cash reserves** raise substantial doubt about its going concern ability[20](index=20&type=chunk) - A **1-for-17 reverse stock split** on March 7, 2025, retroactively restated all share and per-share amounts in financial statements[23](index=23&type=chunk) - A manufacturing agreement with Scorpius BioManufacturing for Entolimod involves an estimated **$4.1 million investment** over two years[91](index=91&type=chunk)[92](index=92&type=chunk) - New financing includes an Equity Line of Credit with Mast Hill Fund for up to **$25 million** and a Tranched Financing agreement for up to **$8.4 million** in Series B Preferred Stock and Warrants[115](index=115&type=chunk)[130](index=130&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=46&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This MD&A details the company's strategic shift to immunotherapeutics and ncVNS, showing decreased ClearUP revenue, increased R&D and G&A expenses, a wider net loss, and ongoing liquidity challenges with new financing efforts [Business Overview](index=46&type=section&id=Business%20Overview) - Tivic Health transitioned into a diversified immunotherapeutics company, focusing on its bioelectronic ncVNS program and new biopharma program with Entolimod™[166](index=166&type=chunk) - Entolimod™, a late-stage biopharmaceutical candidate, has FDA Fast Track designation for Acute Radiation Syndrome (ARS) and is planned for a Phase 2 neutropenia study[167](index=167&type=chunk)[178](index=178&type=chunk) - ClearUP®, an FDA-approved device for sinus pain, is supported by alternative monetization strategies as the company shifts its primary focus[166](index=166&type=chunk)[169](index=169&type=chunk) [Results of Operations](index=60&type=section&id=Results%20of%20Operations) Key Financial Metrics (in thousands) | Metric (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 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $86 | $140 | $156 | $474 | | Gross Profit | $54 | $30 | $104 | $197 | | R&D Expenses | $655 | $302 | $990 | $558 | | Sales & Marketing | $426 | $207 | $605 | $712 | | G&A Expenses | $907 | $787 | $1,949 | $1,674 | | **Net Loss** | **($1,931)** | **($1,266)** | **($3,433)** | **($2,747)** | - Revenue decreased **39%** for Q2 and **67%** for H1 2025 year-over-year, primarily due to reduced ClearUP advertising spend and capital reallocation to the TLR5 program[229](index=229&type=chunk)[230](index=230&type=chunk) - Research and development expenses increased by **$432 thousand** for H1 2025, driven by the new biopharma program and Entolimod manufacturing costs[238](index=238&type=chunk) - Gross margin increased by **41%** in Q2 2025 and **25%** in H1 2025 year-over-year, due to supply chain restructuring and lower-cost logistics[236](index=236&type=chunk) [Liquidity and Capital Resources](index=64&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company had **$1.2 million** in cash and **$47.0 million** accumulated deficit, raising substantial doubt about its going concern ability due to insufficient funds for the next twelve months[245](index=245&type=chunk)[251](index=251&type=chunk) - Operations are financed through equity sales, including an Equity Distribution Agreement with Maxim, an Equity Purchase Agreement with Mast Hill for up to **$25 million**, and a Preferred Purchase Agreement for up to **$8.4 million** in tranched financing[247](index=247&type=chunk)[248](index=248&type=chunk)[250](index=250&type=chunk) - Strategic focus shifted from ClearUP to advancing biologic (TLR5) and bioelectronic (vagus nerve stimulation) pipelines, anticipating increased operating expenses[245](index=245&type=chunk)[252](index=252&type=chunk) - The company plans to reduce ClearUP advertising and is considering alternative monetization strategies, including a potential strategic transaction or exit from the consumer business by year-end[231](index=231&type=chunk)[258](index=258&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=77&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, the company indicates this disclosure is not applicable - This section is not applicable to the company[294](index=294&type=chunk) [Controls and Procedures](index=77&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2025, but acknowledges a material weakness in internal control over financial reporting from December 31, 2024, due to a small accounting team, with remediation efforts underway - The CEO and CFO concluded that disclosure controls and procedures were effective as of June 30, 2025[298](index=298&type=chunk) - A material weakness in internal controls over financial reporting was identified as of December 31, 2024, due to the small accounting team, with remediation under evaluation[300](index=300&type=chunk)[301](index=301&type=chunk) - No material changes occurred during the quarter affecting internal control over financial reporting[302](index=302&type=chunk) [PART II - OTHER INFORMATION](index=80&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Legal Proceedings](index=80&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings that would significantly adversely affect its business or financial condition - The company is not currently a party to any material legal proceedings, litigation, or claims[305](index=305&type=chunk) [Risk Factors](index=80&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors previously disclosed in the Annual Report on Form 10-K have occurred - No material updates or changes to risk factors previously disclosed in the company's Annual Report have occurred[307](index=307&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=80&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of securities not previously reported on Form 8-K occurred during Q2 2025, nor were any stock repurchases made - No unregistered sales of securities not previously disclosed in a Current Report on Form 8-K occurred during Q2 2025[308](index=308&type=chunk) - The company did not repurchase any outstanding equity securities during H1 2025[309](index=309&type=chunk) [Other Information](index=80&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement during H1 2025 - None of the company's directors or officers entered into, modified, or terminated a Rule 10b5-1 trading arrangement during H1 2025[312](index=312&type=chunk) [Exhibits](index=80&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the quarterly report, including various agreements, warrants, and SEC-required certifications - The report includes a list of filed exhibits, such as warrants, securities purchase agreements, license agreements, employment agreements, and officer certifications[313](index=313&type=chunk)[314](index=314&type=chunk)