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]

SEATTLE, Aug. 26, 2025 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced that it will webcast its presentations at four investor conferences in September. The presentations will feature a business overview and update. Sana will present at Citi’s 2025 Biopharma Back-to-School Conference at 3:15 p.m. ET on Tuesday, September 2, 2025.Sana will present at the 2025 Wells Fargo Healthcare Conference at 8:0 ...

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

[Business Highlights and Pipeline Update](index=1&type=section&id=Business%20Highlights%20and%20Pipeline%20Update) Sana reported positive clinical data for its UP421 therapy, advanced its CAR T pipeline with expected 2025 data, and secured $105 million, extending its cash runway into H2 2026 - Presented **positive 6-month clinical results** for its type 1 diabetes study (**UP421**), showing that hypoimmune-modified pancreatic islet cells transplanted without immunosuppression persist, function, and evade immune detection[1](index=1&type=chunk)[3](index=3&type=chunk) - The New England Journal of Medicine published **positive 12-week clinical results** from the **UP421** study[1](index=1&type=chunk)[3](index=3&type=chunk) - Received **positive FDA feedback** from an INTERACT meeting, increasing confidence in moving forward with the GMP master cell bank for **SC451** and filing an **Investigational New Drug (IND) application as early as 2026**[1](index=1&type=chunk)[2](index=2&type=chunk)[7](index=7&type=chunk) - Patient enrollment is ongoing for the **GLEAM trial (SC291)** for autoimmune diseases and **VIVID trial (SC262)** for B-cell malignancies, with **clinical data from both expected in 2025**[1](index=1&type=chunk)[7](index=7&type=chunk) - Plans to file an **IND for SG299** (in vivo CAR T) for a B-cell related disease **as early as 2026**[1](index=1&type=chunk)[7](index=7&type=chunk) Recent Capital Raise (July & August 2025) | Source | Gross Proceeds (Millions USD) | | :--- | :--- | | At-the-market (ATM) offering | $29.5 | | Public Equity Offering | $75.0 | | **Total** | **~$105** | [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Sana's Q2 2025 cash was $72.7 million, operating expenses decreased, and a $44.6 million impairment led to a $93.8 million GAAP net loss [GAAP Financial Results](index=2&type=section&id=GAAP%20Financial%20Results) Q2 2025 GAAP R&D and G&A expenses decreased, and a $44.6 million impairment charge resulted in a $93.8 million net loss Cash Position | Date | Cash, Cash Equivalents, and Marketable Securities (Millions USD) | | :--- | :--- | | June 30, 2025 | $72.7 | | December 31, 2024 | $152.5 | Q2 2025 vs Q2 2024 Operating Expenses (GAAP, in millions) | Expense Category | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | Change (Millions USD) | | :--- | :--- | :--- | :--- | | Research & Development | $29.8 | $60.9 | ($31.1) | | General & Administrative | $10.3 | $16.4 | ($6.1) | - Recorded a **$44.6 million non-cash impairment** of long-lived assets in Q2 2025, primarily related to manufacturing facilities, as the company will now use CDMOs for near-term needs[9](index=9&type=chunk) Q2 2025 vs Q2 2024 Net Loss (GAAP) | Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | | :--- | :--- | :--- | | Net Loss | ($93.8) | ($50.3) | | Net Loss per Share | ($0.39) | ($0.21) | [Non-GAAP Financial Measures](index=4&type=section&id=Non-GAAP%20Financial%20Measures) Q2 2025 non-GAAP net loss was $38.9 million, a significant improvement, with year-to-date non-GAAP operating cash burn at $79.0 million Q2 2025 vs Q2 2024 Net Loss (Non-GAAP) | Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | | :--- | :--- | :--- | | Non-GAAP Net Loss | ($38.9) | ($74.2) | | Non-GAAP Net Loss per Share | ($0.16) | ($0.32) | YTD 2025 vs YTD 2024 Operating Cash Burn (Non-GAAP) | Period | Non-GAAP Operating Cash Burn (Millions USD) | | :--- | :--- | | Six Months Ended June 30, 2025 | ($79.0) | | Six Months Ended June 30, 2024 | ($104.6) | - **Non-GAAP measures** are used by management to exclude highly variable non-cash items, such as changes in fair value of success payments and contingent consideration, and one-time expenses like impairment charges[19](index=19&type=chunk)[20](index=20&type=chunk) [Consolidated Financial Statements](index=6&type=section&id=Consolidated%20Financial%20Statements) This section presents the unaudited Consolidated Balance Sheet and Statements of Operations for June 30, 2025, supporting reported financial results [Selected Consolidated Balance Sheet Data](index=6&type=section&id=Selected%20Consolidated%20Balance%20Sheet%20Data) As of June 30, 2025, total assets were $361.6 million, total liabilities $239.1 million, and stockholders' equity $122.6 million Selected Balance Sheet Data (in thousands) | Account | June 30, 2025 (Thousands USD) | December 31, 2024 (Thousands USD) | | :--- | :--- | :--- | | Cash, cash equivalents, and marketable securities | $72,674 | $152,497 | | Total assets | $361,645 | $501,020 | | Total liabilities | $239,089 | $250,516 | | Total stockholders' equity | $122,556 | $250,504 | [Consolidated Statements of Operations](index=7&type=section&id=Consolidated%20Statements%20of%20Operations) For Q2 2025, total operating expenses were $95.0 million, resulting in a net loss of $93.8 million, or $0.39 per share Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 (Thousands USD) | Six Months Ended June 30, 2025 (Thousands USD) | | :--- | :--- | :--- | | Total operating expenses | $94,975 | $145,605 | | Loss from operations | ($94,975) | ($145,605) | | Net loss | ($93,800) | ($143,189) | | Net loss per common share | ($0.39) | ($0.60) | [Reconciliation of GAAP to Non-GAAP Measures](index=8&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Measures) This section details the reconciliation of GAAP to non-GAAP financial measures, including operating cash burn and net loss, with non-cash adjustments [Reconciliation of Non-GAAP Operating Cash Burn](index=9&type=section&id=Reconciliation%20of%20Non-GAAP%20Operating%20Cash%20Burn) For the six months ended June 30, 2025, non-GAAP operating cash burn was $79.0 million, after adjustments for cash changes and financing Reconciliation to Non-GAAP Operating Cash Burn (Six Months Ended June 30, 2025, in thousands) | Line Item | Amount (Thousands USD) | | :--- | :--- | | Change in cash, cash equivalents, and marketable securities | ($79,823) | | Adjustments (Financing, Capex, etc.) | $832 | | **Operating cash burn – Non-GAAP** | **($78,991)** | [Reconciliation of Non-GAAP Net Loss](index=10&type=section&id=Reconciliation%20of%20Non-GAAP%20Net%20Loss) Q2 2025 GAAP net loss of $93.8 million was adjusted for non-cash items and a $44.6 million impairment, yielding a non-GAAP net loss of $38.9 million Reconciliation to Non-GAAP Net Loss (Three Months Ended June 30, 2025, in thousands) | Line Item | Amount (Thousands USD) | | :--- | :--- | | Net loss – GAAP | ($93,800) | | Adjustment: Change in fair value of liabilities | $10,262 | | Adjustment: Impairment of long-lived assets | $44,611 | | **Net loss – Non-GAAP** | **($38,927)** |

Core Insights - The company presented positive clinical results for its type 1 diabetes study, demonstrating that hypoimmune-modified pancreatic islet cells can function without immunosuppression and maintain stable C-peptide levels [1][3] - The FDA INTERACT meeting has bolstered confidence in advancing the GMP master cell bank for SC451 and filing the Investigational New Drug Application (IND) as early as 2026 [1][2] - The company raised approximately $105 million from common stock sales, providing a cash runway into the second half of 2026 [1][6] Clinical Developments - The type 1 diabetes program has shown promising results, with over 9 million people affected globally, aiming for a treatment that allows long-term normal blood glucose levels without exogenous insulin [2] - The ongoing clinical study of gene-modified primary islet cells (UP421) continues to evaluate safety and function, with expectations to file an IND for SC451 as early as 2026 [8] - The company is enrolling patients in the GLEAM and VIVID trials, with data expected in 2025 [8] Financial Performance - As of Q2 2025, the company reported a cash position of $72.7 million, with a pro forma cash position of $177.2 million after recent financing [1][6] - Research and development expenses for Q2 2025 were $29.8 million, a decrease from $60.9 million in Q2 2024, attributed to lower operational costs [8][9] - The net loss for Q2 2025 was $93.8 million, compared to $50.3 million in Q2 2024, reflecting increased operational expenditures [9][17] Strategic Initiatives - The company is focused on advancing its pipeline across multiple indications, including B-cell mediated autoimmune diseases and malignancies [5][8] - The recent public offering raised $75 million, enhancing the company's financial stability and ability to invest in its pipeline [6][8] - The company aims to develop SG299 for B-cell cancers and autoimmune diseases, with an IND filing expected as early as 2026 [8]

Group 1 - The article discusses the importance of staying updated on stocks in the biotech, pharma, and healthcare industries, highlighting key trends and catalysts that influence market valuations [1] - It mentions the investment group Haggerston BioHealth, which provides insights for both novice and experienced biotech investors, including buy and sell ratings, product sales forecasts, and financial analyses [1] - The author, Edmund Ingham, has extensive experience in the biotech sector, having covered over 1,000 companies and leading the Haggerston BioHealth investing group [1]

Group 1 - Sana Biotechnology, Inc. has priced its underwritten public offering of 20,895,522 shares of common stock at $3.35 per share and pre-funded warrants to purchase 1,492,537 shares at $3.3499 per warrant [1] - The gross proceeds from the offering are expected to be approximately $75.0 million before deducting underwriting discounts and commissions [1] - The offering is expected to close on or about August 8, 2025, subject to customary closing conditions [1] Group 2 - Morgan Stanley, Goldman Sachs & Co. LLC, BofA Securities, and TD Cowen are acting as joint book-running managers for the offering [2] - The offering is being made pursuant to a Registration Statement on Form S-3, which has been declared effective by the SEC [3] - A final prospectus supplement and accompanying prospectus will be filed with the SEC [3] Group 3 - Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients [5] - The company has operations in Seattle, WA, Cambridge, MA, and South San Francisco, CA [5]

Core Viewpoint - Sana Biotechnology, Inc. has announced a public offering of $75 million in common stock and pre-funded warrants, with an additional option for underwriters to purchase up to $11.25 million more [1][2]. Group 1: Offering Details - The public offering consists of $75 million in shares of common stock and pre-funded warrants for certain investors [1]. - The underwriters will have a 30-day option to purchase an additional $11.25 million in shares [1]. - All shares and warrants will be sold by Sana, and the offering is subject to market conditions [1]. Group 2: Underwriters - Morgan Stanley, Goldman Sachs & Co. LLC, BofA Securities, and TD Cowen are acting as joint book-running managers for the offering [2]. Group 3: Regulatory Information - The offering is made under a Registration Statement on Form S-3, which has been declared effective by the SEC [3]. - A preliminary prospectus supplement will be filed to describe the terms of the offering, available through the SEC's website [3]. Group 4: Company Overview - Sana Biotechnology focuses on creating engineered cells as medicines for patients, with operations in Seattle, WA, Cambridge, MA, and South San Francisco, CA [5].

Data Demonstrate that Sana's Hypoimmune (HIP)-Modified Pancreatic Islet Cells, Transplanted with No Immunosuppression, Persist and Function Over Time in Patient with Type 1 Diabetes Study Establishes Ability to Genetically Modify and Transplant Pancreatic Islet Cells Without Immunosuppression and Overcome Both Allogeneic and Autoimmune Rejection Six-Month Patient Follow-up Results Presented at the 85 Annual American Diabetes Association (ADA) Scientific Sessions Further Demonstrate that Sana's HIP-Modified ...