Company Overview - Sana is approximately 6 to 7 years old and was founded with the vision of transforming medicine through gene modification and using cells as therapies [3] - The company aims to establish itself as a leading entity in the evolving field of cell and gene therapy [3] Industry Context - The cell and gene therapy sector is currently facing a challenging operating environment, which the company acknowledges [3] - Despite these challenges, the fundamental belief in the transformative potential of gene modification and cell-based therapies remains strong [3]

Summary of Sana Biotechnology FY Conference Call Company Overview - **Company**: Sana Biotechnology (NasdaqGS:SANA) - **Industry**: Biotechnology, specifically focusing on cell and gene therapy - **CEO**: Steve Harr Core Points and Arguments 1. **Company Vision**: Sana Biotechnology aims to transform medicine through gene modification and cell therapy, focusing on overcoming allogeneic rejection in cell transplants and delivering genetic material to cells in a specific manner [2][3] 2. **Type 1 Diabetes Focus**: The company is making significant progress in developing a curative therapy for type 1 diabetes, which affects approximately 9 million people today, projected to rise to 15 million in 15 years [5][6] 3. **Transformational Therapy**: The goal is to achieve euglycemia (normal blood sugar levels) with a single treatment, eliminating the need for insulin and immunosuppression for life [6][9] 4. **Clinical Progress**: Sana has demonstrated the ability to gene modify cadaveric islets, with a patient successfully producing insulin for the first time in over 40 years, as published in the New England Journal of Medicine [9][16] 5. **Master Cell Bank**: The company has established a master cell bank for gene-modified pluripotent stem cells, which will be used to grow pancreatic islets for transplantation [9][10] 6. **Safety and Efficacy**: Significant efforts have been made to ensure the safety of the gene-modified cells, focusing on avoiding mutations during cell division [12][13] 7. **Regulatory Engagement**: The company has had constructive interactions with regulators, recognizing the transformative potential of their therapy [24][51] Important but Overlooked Content 1. **Challenges in Cell and Gene Therapy**: The industry faces capital intensity issues and societal questions regarding the payment for curative therapies, which could hinder progress [32][33] 2. **Competitive Landscape**: While there are other companies in the space, Sana believes it has a unique position due to its focus on achieving normal blood sugar levels without immunosuppression [25][28] 3. **Patient Population Strategy**: Initial trials will focus on adults, with plans to expand to adolescents and eventually children, aiming to make the therapy available to all individuals with type 1 diabetes over time [29][30] 4. **Fusogene Platform**: The company is also developing a fusogene platform for cell-specific delivery of genetic material, although it faces capital constraints for advancing this technology [35][37] 5. **Capital Needs**: Sana acknowledges the need for additional funding to support its initiatives, particularly for type 1 diabetes and the fusogene platform [39][40] Conclusion Sana Biotechnology is positioned to make significant advancements in the treatment of type 1 diabetes through innovative gene-modified therapies. The company is focused on overcoming regulatory and safety challenges while navigating the competitive landscape and addressing capital needs for future growth.

Core Viewpoint - The research led by Sana Biotechnology offers a potential breakthrough in treating Type 1 Diabetes (T1D) by enabling the survival of transplanted allogeneic beta cells without the need for immunosuppression, which could significantly improve patient outcomes and reduce the risks associated with long-term immunosuppressive therapy [2][4][7]. Group 1: Research Findings - A study published in NEJM demonstrated that CRISPR-Cas12b gene editing was used to modify donor beta cells to avoid immune rejection, allowing these cells to be transplanted into a Type 1 Diabetes patient without immunosuppressive drugs [2][4]. - The patient showed no immune response to the transplanted cells within 12 weeks, and the cells continued to produce insulin, effectively regulating blood sugar levels [2][9]. - This approach represents a significant advancement towards achieving a long-term cure for T1D, with the potential for a one-time treatment that eliminates the need for insulin injections and immunosuppressive medications [9][10]. Group 2: Comparison with Other Companies - Other companies, such as Vertex and Reprogenix, are also exploring stem cell-derived therapies for T1D, but these methods still require immunosuppressive drugs to prevent immune attacks on either donor or patient-derived cells [6][7]. - Vertex's research involved transplanting stem cell-derived islets into 12 patients, with 10 no longer needing insulin after one year, while Reprogenix successfully reprogrammed patients' own fat cells into insulin-producing cells [6][7]. - Unlike these approaches, Sana's method aims to eliminate the need for immunosuppression entirely, which could revolutionize treatment for T1D [7][9]. Group 3: Future Directions and Challenges - The ultimate goal of Sana's research is to apply the "immune stealth" gene editing technique to stem cells, guiding their development into insulin-secreting beta cells, with clinical trials expected to begin next year [9][10]. - However, there are concerns regarding the reproducibility of the protective effects of CD47 and the limited scope of the initial study, which involved only one patient and a small number of transplanted cells [10].

Core Insights - The company believes that cell and gene therapy will be a significant transformation in medicine over the coming decades [1] - The industry has faced challenges, but the company remains optimistic about its progress and future developments [1] Company Perspective - The CEO emphasizes the importance of understanding stock catalysts while focusing on building the business [1] - The company is committed to navigating the complexities of the cell and gene therapy field [1]

Financial Data and Key Metrics Changes - The company is focused on cell and gene therapy, which is expected to transform medicine over the coming decades [6] - The diabetes program is highlighted as potentially one of the most valuable therapies in development, with a large and unsatisfied market [19] Business Line Data and Key Metrics Changes - The company is advancing three categories of therapies: type one diabetes, in vivo CAR T cells, and allogeneic CAR T cells [10][17] - The type one diabetes program aims to provide a single treatment that allows patients to maintain normal blood sugar levels without insulin or immunosuppression [14][19] Market Data and Key Metrics Changes - Type one diabetes affects over nine million people, with estimates suggesting it will grow to fifteen million within fifteen years [12] - The company is optimistic about the scalability of its therapies, particularly in the context of the growing diabetes market [19] Company Strategy and Development Direction - The company aims to overcome allogeneic rejection in cell therapies, which has been a significant challenge in the field [7][17] - The focus is on developing scalable and effective therapies that can be broadly accessible to patients worldwide [62] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the challenges in the cell and gene therapy space but remains optimistic about the potential of their diabetes program [75] - The company is preparing for an IND filing as early as 2026, contingent on successful completion of necessary studies [58][60] Other Important Information - The company has made significant progress in gene editing and manufacturing processes, which are critical for the success of their therapies [46][48] - The management emphasizes the importance of human data to unlock value in their programs, particularly for CAR T therapies [73] Q&A Session Summary Question: Can you provide an overview of the type one diabetes program and recent data? - The type one diabetes program has shown promising results, with the first patient treated demonstrating functioning cells for over six months [24][28] Question: What are the next steps for the iPSC product? - The company is focused on finalizing the master cell bank and completing the necessary toxicology studies before filing for IND [50][55] Question: How does the company plan to address the challenges in manufacturing stem cell-derived products? - The management highlighted the importance of purity, potency, and yield in manufacturing, which are critical for safety and efficacy [52][53] Question: What is the company's strategy for partnerships in the CAR T space? - The company is exploring partnerships to advance its CAR T programs, recognizing the need for capital to move forward [75][78]

Core Insights - The company has been operational for approximately 6.5 years, indicating a relatively young age in the industry while having gained valuable experience through successes and mistakes [1] Company Vision - The company was founded with the vision that cell modification will be a significant advancement in medicine over the coming decades, suggesting a long-term commitment to this innovative approach [1] - Despite current skepticism in the industry regarding cell modification as a viable treatment, the company remains confident in its potential and the likelihood of its success [1]

Summary of Sana Biotechnology (SANA) Conference Call - September 02, 2025 Company Overview - **Company**: Sana Biotechnology (SANA) - **Industry**: Biotechnology - **Focus**: Cell modification and gene therapy for diseases, particularly type one diabetes and CAR T cell therapies Key Points and Arguments 1. **Company Age and Progress**: Sana Biotechnology is approximately six and a half years old, having made significant progress in cell modification technologies and addressing scientific challenges in cell transplantation and in vivo payload delivery [3][4] 2. **Scientific Challenges**: The company aims to overcome challenges related to cell persistence and allogeneic rejection in cell therapies, focusing on scalable solutions for broad populations [4][5] 3. **Product Development**: - **S C 451**: A gene-modified stem cell-derived pancreatic islet therapy for type one diabetes, addressing a significant unmet need for the nine million people affected globally [6][7] - **In Vivo CAR T Cells**: The company is advancing its in vivo CAR T cell therapies, showing promising data in nonhuman primates and preparing to move towards human trials [8][9] - **Allogeneic CAR T Cells**: Development of allogeneic CAR T cells is ongoing, with recent publications demonstrating the ability to avoid immune detection [10][11] 4. **FDA Interaction**: Positive feedback from the FDA regarding the type one diabetes program has instilled confidence in the company’s ability to move forward with its lead GMP cell line [15][16] 5. **Master Cell Bank**: The company has developed a master cell bank that has shown no mutations after extensive divisions, which is crucial for ensuring the safety and efficacy of the therapy [20][21][24] 6. **Manufacturing and Scaling**: The company recognizes the need for scalable manufacturing processes to meet the potential demand for its therapies, particularly for type one diabetes, which is projected to grow significantly [62][63] 7. **Market Opportunity**: The potential market for type one diabetes therapies is vast, with a focus on making treatments accessible to a large patient population over time [57][61] 8. **Funding and Partnerships**: The company is exploring partnerships to fund its various programs, particularly S C 451, while ensuring that it retains significant ownership of its most transformative asset [78][79] 9. **Competitive Landscape**: Sana Biotechnology believes it has a best-in-class platform for CAR T therapies, emphasizing the importance of cell specificity and delivery in its approach [82][83] 10. **Clinical Development Timeline**: The company is working towards filing an IND for its therapies, with a focus on completing necessary preclinical studies and GMP manufacturing [35][88] Additional Important Content - **Patient Safety and Efficacy**: The company is cautious about patient selection for initial trials, particularly for those with preexisting conditions that may complicate outcomes [58][59] - **Regulatory Alignment**: Ongoing discussions with the FDA are crucial for ensuring that the company meets all regulatory requirements for its therapies [44][45] - **Long-term Vision**: The leadership expresses optimism about the potential to transform the treatment landscape for type one diabetes, highlighting the lack of significant advancements in over a century [102][103]

Core Viewpoint - Sana Biotechnology, Inc. is set to present at four investor conferences in September 2025, providing a business overview and updates on its engineered cell therapies [1][5]. Company Overview - Sana Biotechnology focuses on creating engineered cells as medicines, aiming to repair and control genes, and replace missing or damaged cells [3]. - The company operates in Seattle, WA, Cambridge, MA, and South San Francisco, CA [3]. Upcoming Events - Sana will present at the following conferences: - Citi's 2025 Biopharma Back-to-School Conference on September 2, 2025, at 3:15 p.m. ET [5]. - 2025 Wells Fargo Healthcare Conference on September 4, 2025, at 8:00 a.m. ET [5]. - Morgan Stanley 23 Annual Global Healthcare Conference on September 8, 2025, at 11:30 a.m. ET [5]. - HC Wainwright 27 Annual Global Investment Conference on September 9, 2025, at 9:30 a.m. ET [5]. Investor Relations - Webcasts of the presentations will be available on the Investor Relations page of Sana's website, with replays accessible for 30 days post-conference [2].

Group 1 - Sana Biotechnology, Inc. has successfully closed the sale of 3,358,208 shares of its common stock at a price of $3.35 per share, resulting in total gross proceeds of approximately $86.3 million [1] - The offering was part of a previously announced underwritten public offering that closed on August 8, 2025, and included the full exercise of the underwriters' option to purchase additional shares [1] - The joint book-running managers for the offering included Morgan Stanley, Goldman Sachs & Co. LLC, BofA Securities, and TD Cowen [2] Group 2 - The offering was conducted under a Registration Statement on Form S-3, which was previously filed and declared effective by the SEC [3] - Final prospectus supplement and accompanying prospectus related to the offering have been filed with the SEC and are accessible through the SEC's website [3] - Sana Biotechnology is focused on creating and delivering engineered cells as medicines for patients, with operations in Seattle, WA, Cambridge, MA, and South San Francisco, CA [5]

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) H1 2025 unaudited financials report a $143.2 million net loss, $361.6 million total assets, and a $44.6 million impairment [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | Financial Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $71,271 | $127,566 | | Total current assets | $82,502 | $160,808 | | Total Assets | $361,645 | $501,020 | | Total Liabilities | $239,089 | $250,516 | | Total Stockholders' Equity | $122,556 | $250,504 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) | 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 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $29,761 | $60,874 | $66,950 | $117,322 | | Impairment of long-lived assets | $44,611 | - | $44,611 | - | | Total operating expenses | $94,975 | $49,372 | $145,605 | $160,096 | | Net loss | $(93,800) | $(50,291) | $(143,189) | $(157,766) | | Net loss per share | $(0.39) | $(0.21) | $(0.60) | $(0.70) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(81,758) | $(124,173) | | Net cash provided by (used in) investing activities | $24,283 | $(71,410) | | Net cash provided by financing activities | $1,543 | $197,024 | | Net decrease in cash, cash equivalents, and restricted cash | $(55,932) | $1,441 | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - As of June 30, 2025, the company had **$72.7 million** in cash, cash equivalents, and marketable securities. Subsequent financing, including a **$70.0 million** public offering in August 2025 and **$28.6 million** from an ATM facility, is expected to fund operations for at least one year, removing substantial doubt about its ability to continue as a going concern[30](index=30&type=chunk)[33](index=33&type=chunk) - In Q2 2025, the company recognized a **$44.6 million** non-cash impairment loss on long-lived assets. This was primarily related to its manufacturing facilities in Bothell and Seattle, following a decision to suspend the build-out of internal manufacturing capabilities due to increased availability of third-party capacity[75](index=75&type=chunk)[121](index=121&type=chunk) - The fair value of the Cobalt Contingent Consideration liability increased to **$117.1 million** as of June 30, 2025, from **$109.0 million** at year-end 2024. The change in fair value is recognized in R&D expenses[52](index=52&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) H1 2025 net loss decreased to $143.2 million due to portfolio prioritization, offset by a $44.6 million impairment, with recent financing bolstering liquidity [Overview](index=27&type=section&id=Overview) - Sana is developing ex vivo and in vivo cell engineering platforms to treat a broad array of therapeutic areas, including type 1 diabetes, B-cell mediated autoimmune diseases, and oncology[91](index=91&type=chunk) - The clinical pipeline includes three ongoing trials: SC291 in autoimmune diseases (GLEAM study), SC262 in B-cell malignancies (VIVID study), and an investigator-sponsored trial of UP421 for type 1 diabetes. Data from the GLEAM and VIVID trials are expected in 2025[93](index=93&type=chunk) - In November 2024, the company prioritized its portfolio to focus on T1D, autoimmune diseases, refractory B-cell malignancies, and the fusogen platform for in vivo CAR T cells. Development of SC291 in oncology and the SC379 glial progenitor program were suspended to seek partnerships[99](index=99&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20operations) | Metric (in millions) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $67.0 | $117.3 | | General and administrative | $21.8 | $32.7 | | Impairment of long-lived assets | $44.6 | $0.0 | | **Total operating expenses** | **$145.6** | **$160.1** | | **Net loss** | **$(143.2)** | **$(157.8)** | - R&D expenses for the first six months of 2025 decreased by **$50.4 million** compared to the same period in 2024, primarily due to lower headcount and reduced laboratory, research, and clinical development costs following the November 2024 portfolio prioritization[124](index=124&type=chunk)[126](index=126&type=chunk) - G&A expenses for the first six months of 2025 decreased by **$10.9 million** compared to the prior year period, mainly due to lower personnel-related costs and reduced legal and consulting fees as a result of the portfolio prioritization[129](index=129&type=chunk)[131](index=131&type=chunk) [Liquidity, Capital Resources, and Capital Requirements](index=37&type=section&id=Liquidity,%20capital%20resources,%20and%20capital%20requirements) - As of June 30, 2025, the company had **$72.7 million** in cash, cash equivalents, and marketable securities[135](index=135&type=chunk) - Subsequent to the quarter end, the company raised approximately **$70.0 million** in net proceeds from a public offering in August 2025 and an additional **$28.6 million** from its ATM facility[136](index=136&type=chunk)[137](index=137&type=chunk) - Management believes that existing cash, combined with recent financing proceeds, will be sufficient to fund planned operations for at least one year from the filing of the report[141](index=141&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Market risks primarily involve interest rate sensitivities and stock price volatility, with a 20% change in market capitalization materially impacting liabilities - The company's exposure to interest rate risk is not considered significant due to the short-term duration of its **$1.4 million** in marketable securities as of June 30, 2025[159](index=159&type=chunk) - The fair value of success payment liabilities is highly sensitive to the company's stock price and market capitalization. A hypothetical **20% increase** in market capitalization as of June 30, 2025, would have increased the related Q2 expense by **$1.9 million**[162](index=162&type=chunk) [Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting - Management concluded that as of June 30, 2025, the company's disclosure controls and procedures were effective at a reasonable assurance level[166](index=166&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[167](index=167&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) A putative class action lawsuit filed March 21, 2025, alleges false and misleading statements, which the company intends to vigorously defend - A putative class action complaint was filed against the company and its executives on March 21, 2025, alleging false and misleading statements concerning the company's business, operations, and prospects[170](index=170&type=chunk) - The lawsuit, captioned *In re Sana Biotechnology, Inc. Securities Litigation*, covers the period from March 17, 2023, to November 4, 2024. The company intends to defend itself vigorously[170](index=170&type=chunk) [Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) Significant risks include unproven cell engineering platforms, funding needs, third-party reliance, intellectual property, regulatory hurdles, and limited operating history [Risks Related to Our Business and Industry](index=49&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) - The company's ex vivo and in vivo cell engineering platforms are based on novel, unproven technologies, which makes predicting development time, cost, and ultimate success difficult and exposes the company to unforeseen risks[175](index=175&type=chunk) - The company may not realize the expected benefits from acquired or in-licensed technologies, such as the fusogen platform from Cobalt, due to portfolio reprioritizations and development challenges[185](index=185&type=chunk)[187](index=187&type=chunk) - Negative public opinion and increased regulatory scrutiny of gene editing and cell engineering technologies could damage public perception and hinder the ability to conduct business or obtain approvals[213](index=213&type=chunk) [Risks Related to the Development and Clinical Testing of Our Product Candidates](index=61&type=section&id=Risks%20Related%20to%20the%20Development%20and%20Clinical%20Testing%20of%20Our%20Product%20Candidates) - Clinical drug development is a lengthy, expensive, and uncertain process; positive results in early studies may not be predictive of future trial success[215](index=215&type=chunk)[217](index=217&type=chunk) - The manufacture of product candidates is complex and may encounter difficulties in production and scaling, which could delay or halt supply for clinical trials or commercial sale[248](index=248&type=chunk) - The supply chain for materials is subject to risks, including reliance on sole-source vendors and potential shortages of key reagents, consumables, and equipment, which could disrupt manufacturing[253](index=253&type=chunk)[256](index=256&type=chunk) [Risks Related to Our Dependence on Third Parties](index=76&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) - The company relies on a limited number of Contract Development and Manufacturing Organizations (CDMOs) for manufacturing, which poses risks related to capacity, regulatory compliance (cGMP), and potential production delays[263](index=263&type=chunk)[264](index=264&type=chunk) - The company depends on third parties like CROs and clinical trial sites to conduct studies; failure of these parties to perform their duties or comply with regulations (GCP) could compromise data and delay programs[272](index=272&type=chunk) [Risks Related to Intellectual Property and Information Technology](index=81&type=section&id=Risks%20Related%20to%20Intellectual%20Property%20and%20Information%20Technology) - The company's success depends on protecting its intellectual property, but it may not be able to protect these rights in all countries, and enforcement is costly and uncertain[276](index=276&type=chunk) - The company depends on intellectual property licensed from third parties (e.g., Harvard, Cobalt); breaching these agreements could result in the loss of significant rights[280](index=280&type=chunk)[281](index=281&type=chunk) - Internal computer systems and those of third-party vendors are vulnerable to security breaches and cyberattacks, which could compromise confidential information, including trade secrets and clinical trial data[322](index=322&type=chunk)[323](index=323&type=chunk) [Risks Related to Our Regulatory Environment](index=102&type=section&id=Risks%20Related%20to%20Our%20Regulatory%20Environment) - The regulatory approval process for biopharmaceutical products is lengthy, expensive, and unpredictable, and the company has no experience submitting a Biologics License Application (BLA)[336](index=336&type=chunk)[338](index=338&type=chunk) - Even if approved, products will be subject to ongoing regulatory review, post-marketing requirements, and potential restrictions, which could be costly and limit commercialization[351](index=351&type=chunk) - Recent and future healthcare legislation, such as the Inflation Reduction Act (IRA), could increase costs, affect drug pricing, and negatively impact the company's ability to generate revenue[364](index=364&type=chunk)[367](index=367&type=chunk) [Risks Related to Our Limited Operating History, Financial Condition, and Need for Additional Capital](index=124&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History,%20Financial%20Condition,%20and%20Need%20for%20Additional%20Capital) - The company will require substantial additional funding to finance operations and could be forced to delay, reduce, or eliminate programs if unable to raise capital on acceptable terms[399](index=399&type=chunk) - The company has a history of significant losses (**$1.7 billion** accumulated deficit as of June 30, 2025) and may never achieve or maintain profitability[408](index=408&type=chunk) - Success payment and contingent consideration obligations to Harvard and Cobalt could result in stockholder dilution, drain cash resources, and cause significant fluctuations in reported financial results[413](index=413&type=chunk)[416](index=416&type=chunk) [Risks Related to Commercialization of Our Product Candidates](index=132&type=section&id=Risks%20Related%20to%20Commercialization%20of%20Our%20Product%20Candidates) - The biotechnology industry is highly competitive, and competitors with greater resources may develop and commercialize products more successfully or render the company's technology obsolete[419](index=419&type=chunk)[420](index=420&type=chunk) - The addressable patient populations for the company's product candidates may be smaller than estimated, limiting market opportunity[424](index=424&type=chunk) - The company currently lacks marketing, sales, and distribution infrastructure and faces substantial risks whether it chooses to build its own or outsource these functions[427](index=427&type=chunk) [Risks Related to Ownership of Our Common Stock](index=135&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) - As of June 30, 2025, principal stockholders and management owned approximately **59.9%** of the company's stock, allowing them to exert significant control over corporate matters[434](index=434&type=chunk) - Future sales of securities by the company or existing stockholders could cause the stock price to fall due to dilution and market pressure[435](index=435&type=chunk)[438](index=438&type=chunk) - Provisions in the company's charter and bylaws, along with Delaware law, could discourage or prevent a change in control, potentially depressing the market price of the stock[440](index=440&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=153&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company did not sell any unregistered securities during the three months ended June 30, 2025 - The company did not sell any unregistered securities in the three months ended June 30, 2025[479](index=479&type=chunk) [Defaults Upon Senior Securities](index=153&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Not applicable [Mine Safety Disclosures](index=153&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable [Other Information](index=153&type=section&id=Item%205.%20Other%20Information) During the last fiscal quarter, no director or officer adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement - No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the last fiscal quarter[482](index=482&type=chunk) [Exhibits](index=154&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the company's certificate of incorporation, bylaws, forms of stock and warrant certificates, a license agreement amendment, a sales agreement, and officer certifications