[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]

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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].

Core Insights - The study demonstrates that Sana's hypoimmune (HIP)-modified pancreatic islet cells can be transplanted without immunosuppression, showing persistence and insulin production over time in a patient with type 1 diabetes [1][2][6] - The results indicate a significant advancement towards a functional cure for type 1 diabetes, as the patient was able to produce insulin independently for the first time in over 35 years [2][3] - The company plans to file an Investigational New Drug application for SC451, a HIP-modified stem cell-derived therapy, as early as 2026 [1][2] Study Findings - The study involved the transplantation of HIP-modified pancreatic islet cells into a 42-year-old patient, with results showing that these cells evade immune detection and continue to function [1][9] - Six-month follow-up results confirmed the survival and function of the transplanted cells, indicated by the presence of circulating C-peptide, a biomarker for insulin production [7][9] - MRI scans showed consistent signals at the transplant site, confirming graft survival [9] Technology and Development - Sana's HIP platform is designed to create cells that can evade the immune system, allowing for the transplantation of allogeneic cells without the need for immunosuppression [8][10] - The company is developing multiple therapeutic candidates using this platform, including stem cell-derived pancreatic islet cells and CAR T cells for various diseases [8][10] - The ongoing study is supported by a grant from The Leona M. and Harry B. Helmsley Charitable Trust, emphasizing the significance of the research [5]

Type 1 Diabetes (T1D) Program - Sana's hypoimmune platform (HIP) overcomes allogeneic rejection in people, which is confirmed by 4-week and 12-week data[4] - Type 1 diabetes affects 94 million children and adults, and is projected to affect 164 million by 2040[12, 13] - Type 1 diabetes leads to 201600 deaths per year and costs $81 billion worldwide annually[17] - SC451, a HIP-modified stem cell-derived pancreatic islet therapy, is advancing toward the clinic with an expected IND filing as early as 2026[114] - HIP-modified PSC differentiated islet cells transplanted into muscle persist & control blood glucose in mice for >15 months[64] Autoimmune Disease Program - B-cell mediated autoimmune diseases affect >5 million patients[68] - SC291, a HIP-modified CD19 CAR T, leads to deep B-cell depletion and has significant potential in B-cell mediated autoimmune diseases, with an ongoing GLEAM study[114] - Sana's T cell manufacturing process provides ~85% full knock-out of MHC class I and II, >995% TCR negative cells[79] - Fusogen platform offers the potential to treat B-cell mediated autoimmune diseases and B-cell cancers with NO lymphodepletion with an expected IND filing as early as 2026[114] Oncology Program - SC262, a HIP-modified CD22 CAR T, has meaningful potential in treating CD19 CAR T relapsed patients, with an ongoing VIVID study[114] - Estimated ~12000 B cell malignancy patients treated with CD19 CAR T in 2027, with ~35-40% durable complete responses, leading to ~7500 CAR T failures annually[106]

Core Insights - The study demonstrates the potential of Sana's hypoimmune (HIP) technology to treat type 1 diabetes by transplanting insulin-secreting cells without the need for immunosuppression, showing promising results over a six-month follow-up period [1][2][5] - The results indicate that transplanted pancreatic islet cells are safe, well-tolerated, and continue to produce insulin, as evidenced by consistent levels of circulating C-peptide [1][5] - The study is a collaboration with Uppsala University Hospital and aims to develop a one-time treatment for type 1 diabetes that achieves normal blood glucose levels without insulin or immunosuppression [1][4] Study Results - Six-month follow-up results show that the transplanted islet cells survived and functioned effectively, indicated by the presence of circulating C-peptide, a biomarker for insulin production [1][5] - C-peptide levels increased during a mixed meal tolerance test (MMTT), confirming insulin secretion in response to meals [1][5] - MRI scans indicated signals consistent with graft survival six months post-transplantation [1] Technology and Development - Sana's HIP technology is designed to enable the transplantation of allogeneic cells without immunosuppression, addressing the challenge of immune rejection in type 1 diabetes [3][6] - The company plans to incorporate findings from the UP421 trial into the development of SC451, a HIP-modified, stem cell-derived therapy for type 1 diabetes, with an investigational new drug application (IND) expected to be filed next year [2][6] - The HIP platform has shown proof-of-concept in humans, demonstrating the ability to evade immune recognition while retaining cell activity [5][6] Industry Impact - Type 1 diabetes affects over nine million people globally, and advancements in treatment options are crucial for improving patient outcomes [2][3] - The potential to administer insulin-producing cells could transform diabetes management, reducing reliance on lifelong insulin injections and immunosuppressive drugs [3][4] - The study's findings may lead to broader applications of cellular and transplant medicine, making these therapies more accessible to patients [2][3]

Summary of Sana Biotechnology (SANA) FY Conference Call - June 10, 2025 Company Overview - **Company**: Sana Biotechnology (SANA) - **Industry**: Biotechnology - **Focus**: Development of cell-based therapies, particularly for type one diabetes and CAR T cell therapies Key Points and Arguments Portfolio Strategy and Pipeline - The company is focused on using cells as medicines, specifically through two technologies: hypoimmune technology and in vivo gene modification [3][4] - The majority of capital is allocated towards the hypoimmune platform, which aims to hide cells from immune system recognition, particularly in type one diabetes [5][12] - Type one diabetes affects approximately 9 million people globally, with about 2 million in the U.S., and has seen little meaningful progress in treatment over the past century [6][7] - The goal is to provide a single treatment that results in normal blood sugar levels for life without the need for insulin or immunosuppression [8][12] Type One Diabetes Program - The lead program, SC451, is a hypoimmune iPSC-derived islet cell therapy expected to file an IND in 2026 [15] - Investigator-sponsored trials have shown promising results, including a patient making insulin without immunosuppression for over 35 years [21][22] - The therapy aims to be scalable and consistent, addressing the limitations of current treatments that require lifelong immunosuppression [24][53] Risks and Challenges - Major risks identified include capital and time constraints, safety concerns, and the need for scalable manufacturing [56][57] - The company is focused on ensuring product purity to avoid tumor emergence, which is critical for long-term patient safety [56] CAR T Cell Programs - The company is also developing allogeneic CAR T therapies for oncology and autoimmune diseases, facing competition and investor fatigue in the CAR T space [9][10][11] - The allogeneic CAR T program aims to provide off-the-shelf therapies that do not require patient-specific modifications [61][64] - The company is optimistic about achieving deep B cell depletion in autoimmune settings based on oncology data [62][64] Competitive Landscape - The company differentiates itself by eliminating the need for immunosuppression in its therapies, which is a significant advantage over competitors [52][53] - The market for type one diabetes treatments is vast, with potential for significant revenue if successful [51] Financial Strategy and Partnerships - The company acknowledges the need for additional funding to support its various programs and is exploring partnerships as a non-dilutive option [74][75] - There is a strong commitment to protect the type one diabetes franchise while seeking capital for other programs [75][76] Upcoming Data and Expectations - The company plans to present updated data at the American Diabetes Association meeting, with expectations for stable C peptide levels and glucose-sensitive insulin secretion [35][36] - The focus remains on ensuring that the therapy meets safety and efficacy standards before moving forward with broader applications [66][67] Additional Important Content - The company has made significant progress in developing a master iPSC cell bank, which is crucial for scaling production [41][49] - The challenges of scaling production to meet the needs of millions of patients are acknowledged, with ongoing efforts to ensure genomic stability [46][47] This summary encapsulates the key points discussed during the conference call, highlighting Sana Biotechnology's strategic focus, challenges, and future expectations in the biotechnology sector.

Core Insights - Sana Biotechnology, Inc. is set to present updated six-month clinical results of a hypoimmune-modified primary pancreatic islet cell therapy for type 1 diabetes at the upcoming American Diabetes Association (ADA) Scientific Sessions [1] - The presentation will focus on the first-in-human study of UP421, an allogeneic primary islet cell therapy utilizing Sana's hypoimmune (HIP) technology, which does not require immunosuppression [1] Presentation Details - The presentation titled "Hypoimmune Pancreatic Islet Transplantation in Adult Subjects with Type 1 Diabetes" will take place on June 23, 2025, from 9:00 to 9:20 a.m. CT at the joint ADA/IPITA symposium [2] - The symposium is themed "Outpacing the Immune System—Sprinting Towards Immune Protection for Cell Replacement Therapy" [2] Company Overview - Sana Biotechnology, Inc. is dedicated to creating engineered cells as medicines, aiming to repair and control genes, and replace missing or damaged cells [3] - The company operates in multiple locations including Seattle, WA, Cambridge, MA, South San Francisco, CA, and Bothell, WA [3]