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| Item 7.01 | Regulation FD Disclosure. |
Sana Biotechnology, Inc. (the “Company”) intends to discuss an updated corporate presentation (the “Corporate Presentation”) at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025. A copy of the Corporate Presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Current Report”) and is incorporated by reference herein.
By furnishing the information in this Item 7.01 of this Current Report, including Exhibit 99.1, the Company makes no admission as to the materiality of such information. The information contained herein is intended to be considered in the context of the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”) and other public announcements that the Company makes, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in the Corporate Presentation, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure.
In accordance with General Instruction B.2 of Form 8-K, the information furnished with this Current Report, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
See the Exhibit Index below, which is incorporated by reference herein.
EXHIBIT INDEX
| Exhibit Number |
Description | |
| 99.1 | Corporate Presentation dated January 13, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Sana Biotechnology, Inc. | ||||||
| Date: January 13, 2025 | By: | /s/ Bernard J. Cassidy | ||||
| Bernard J. Cassidy | ||||||
| Executive Vice President and General Counsel | ||||||
Exhibit 99.1 Corporate Presentation January 2025
Cautionary Note Regarding Forward-Looking Statements This presentation contains forward-looking statements about Sana Biotechnology, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws. All statements other than statements of historical facts contained in this presentation, including, among others, statements regarding the Company’s strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward- looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company’s current and future research and development programs, preclinical studies, and clinical trials. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s SEC reports, including its Quarterly Report on Form 10-Q dated November 8, 2024. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason. © 2020-2025 Sana Biotechnology. All rights reserved. 2
Sana Biotechnology Changing the Possible for Patients Recent data confirm Sana's hypoimmune platform (HIP) overcomes allogeneic rejection in people Ÿ Transplanted HIP-modified pancreatic islets overcome allogeneic and autoimmune rejection in type 1 diabetes Ÿ We believe T1D result generalizable across many cell types and patient populations HIP technology provides foundation for multiple drugs across multiple large therapeutic areas Ÿ Type 1 diabetes – SC451 Ÿ B-cell mediated autoimmune diseases (lupus, vasculitis, others) – SC291 Ÿ Blood cancers – SC262 Fusogen platform proof of concept for in vivo CAR T cells Ÿ Potential for potent CAR T cells with no conditioning chemotherapy and opportunity to transform the autoimmune landscape Balance sheet allows potential for multiple data readouts © 2020-2025 Sana Biotechnology. All rights reserved. 3
Overcoming allogeneic immune rejection has been key limitation in transplant and cellular medicine Allogeneic cell rejection Sana’s hypoimmune approach Ÿ ~75 years of transplants – immune rejection remains the largest problem Blocks innate Blocks adaptive immune system immune system Ÿ Lifelong immunosuppression is current standard 1 2 3 Disruption of MHC Class I & Overexpression of Ÿ Genome modification efforts to date have II expression CD47 generally been incomplete Ÿ Autologous therapies have limited scalability and are only available for a small number of cell types - MHC I + CD47 Healthy donor Hypoimmune Ÿ Sana has published and/or presented cells cells positive data with the HIP platform showing - MHC II the ability to overcome allogeneic rejection from many cell types and multiple species Current clinical platform with multiple ongoing approaches in research phase. © 2020-2025 Sana Biotechnology. All rights reserved. 4
Type 1 diabetes (T1D) remains a significant unmet need Improvement in glycemic control reduces microvascular complications Ÿ T1D is an autoimmune destruction of insulin-producing pancreatic beta 1 but increases the risk of hypoglycemia cells and leads to lifelong insulin therapy requirement Ÿ 8.4M people WW have T1D, and incidence is increasing. Prevalence is expected to double over next 15 years Ÿ 80% of individuals with T1D are from high-income countries Ÿ Insulin therapy has been transformative, but not curative Ÿ T1D leads to more than a decade shorter life expectancy despite significant advances such as continuous glucose monitoring, insulin pumps, and novel forms of insulin Ÿ Complications directly related to hyperglycemia include microvascular (retinopathy, nephropathy, neuropathy) and macrovascular (coronary artery disease, heart attacks, stroke, wound healing, and amputations) issues Ÿ At the other extreme, severe hypoglycemia can be rapidly fatal 1 Diabetes Control and Complications Trial Research Group et. Al. N Engl J Med 1993; 329:977-986 © 2020-2025 Sana Biotechnology. All rights reserved. 5
Advancing toward a cure for broad T1D population T1D is a disease of missing pancreatic beta cells 1 2 Primary islet transplants provide Stem-cell derived islets provide The Goal: long-term glucose control, but: a scalable supply, but: A single treatment with • Supply is an issue long-term normal blood glucose • Still requires chronic • Requires chronic without immunosuppression immunosuppression Immunosuppression or insulin therapy 3 Eliminate the need for Abbreviations: T1D, type 1 diabetes. immunosuppression © 2020-2025 Sana Biotechnology. All rights reserved. 6
Potential clinical validation of hypoimmune islet cells in T1DM patients IST Design Ÿ Trial at Uppsala University Hospital 1 2 3 Ÿ Primary human HIP-modified islet cells transplanted in type 1 diabetes patients Ÿ Intramuscular administration in forearm Ÿ No immunosuppression Transplant into HIP gene Ÿ Insights for SC451 Donor cadaveric modification of T1DM patient without islet cells islet cells immunosuppression Key Measured Outcomes Safety Immune evasion Cell survival C-peptide © 2020-2025 Sana Biotechnology. All rights reserved. 7
All primary and secondary endpoints met Primary and Secondary Endpoints: Data Summary Endpoints D7 D14 D21 D28 Safety (no AE/SAE related to drug) Cell survival/function (C-peptide) Not performed Graft visibility (MRI) (as per protocol) Adaptive immune evasion Innate immune evasion © 2020-2025 Sana Biotechnology. All rights reserved. 8
Stable C-peptide demonstrates survival and function of cells after HIP islet cell transplantation Basal C-peptide in peripheral blood 15 11.4 11.3 12 10.2 9.7 9 6 3 0 Baseline D7 D14 D21 D28 Summary: No detectable C-peptide before transplantation; present and stable C-peptide observed after transplantation. Baseline: Below limit of detection (LOD).Sensitivity: 0.48 pmol/L. Dots represent technical triplicates. C-peptide analyzed in serum. © 2020-2025 Sana Biotechnology. All rights reserved. 9 pmol/L
Increased C-peptide levels with a mixed meal tolerance test (MMTT) highlight survival and function Before transplantation Day 28 20 17.2 17.0 16.3 15 13.4 12.1 10 10.5 5 0 0 30 60 90 120 Time (min) Summary: Before transplantation, C-peptide is below detection limit during MMTT. 28 days after UP421 transplantation, C-peptide is present and stimulated by MMTT. Baseline: Below limit of detection (LOD).Sensitivity: 0.48 pmol/L. Standard deviation represent technical triplicates. C-peptide analyzed in plasma samples. © 2020-2025 Sana Biotechnology. All rights reserved. 10 pmol/L
Day 28 MRI: Further evidence of graft survival MR T2-STIR-weighted trans images showing signal in musculus brachioradialis after injection of UP421 Arrows indicate the location of some examples of injected cells D28 MRI showing several punctual signals at the site of graft injection, no inflammation and no safety/ pathological related observations The MR T2-STIR-weighted sequence is sensitive to water and fluid and is a fat suppression technique to suppress the high signal from fat. Abbreviations: STIR, short TI inversion recovery. © 2020-2025 Sana Biotechnology. All rights reserved. 11
The drug product’s mixed cell population allows detailed immune analysis Donor islet cells contain wild type & double knockout cells as well as HIP cells Donor Immune analysis using patient’s (recipient) immune cells after transplantation + CD47 HLA I HIP islet cells Ÿ T cells HLA II Ÿ Donor-specific antibodies CD47 HLA I Ÿ Natural killer cells dKO islet cells HLA II Ÿ Whole blood CD47 HLA I WT islet cells HLA II Abbreviations: dKO, double knock-out; HIP, hypoimmune; WT, wild type. © 2020-2025 Sana Biotechnology. All rights reserved. 12
Unmodified islet cells: Do not evade T cell or B cell immune response WT islet cells WT islet cells WT islet cells Patient’s T cells are activated and kill WT Patient’s B cells produce donor-specific CD47 HLA I islet cells with peak at 7 days after transplant antibodies (switch from IgM to IgG at D14) 800 200 685 576 600 150 128 HLA II 457 98 400 100 85 301 67 60 200 50 21 0 0 Baseline D7 D14 D21 D28 Baseline D7 D14 D21 D28 200 Baseline D28 1.5 1.5 150 129 125 1.0 1.0 88 100 no killing 61 62 0.5 0.5 50 killing 0.0 0.0 0 10 20 30 40 50 10 20 30 40 50 Baseline D7 D14 D21 D28 Hours Hours -0.5 -0.5 Abbreviations: D, day; WT, wild type. © 2020-2025 Sana Biotechnology. All rights reserved. 13 Normalized Cell Index Spot Frequency Normalized Cell Index IgG MFI IgM MFI
dKO islet cells: Evade B and T cell responses but are killed by NK cells dKO islet cells dKO islet cells dKO islet cells dKO islet cells No killing of HLA deficient cells No binding of donor-specific Patient’s NK cells are killing CD47 HLA I by patient’s T cells antibodies to HLA deficient cells HLA I/II deficient cells (due to “missing-self”) 800 200 Baseline 1.5 600 150 HLA II 1.0 400 100 61 62 61 62 59 0.5 200 50 killing 20 23 21 23 20 0 0 0.0 10 20 30 40 50 Baseline D7 D14 D21 D28 BL D7 D14 D21 D28 Hours -0.5 Baseline D28 200 D28 1.5 1.5 1.5 150 1.0 1.0 1.0 no killing no killing 100 0.5 0.5 0.5 60 60 60 61 59 killing 50 0.0 0.0 0.0 10 20 30 40 50 10 20 30 40 50 10 20 30 40 50 0 Hours Hours Hours -0.5 -0.5 -0.5 BL D7 D14 D21 D28 Abbreviations: BL, baseline. © 2020-2025 Sana Biotechnology. All rights reserved. 14 Spot Frequency Normalized Cell Index Normalized Cell Index IgG MFI IgM MFI Normalized Cell Index Normalized Cell Index
HIP islet cells: Evade T cell, B cell, and NK cell immune responses HIP islet cells HIP islet cells HIP islet cells HIP islet cells No killing of HIP islet cells No binding of donor-specific No killing of HIP islet cells + CD47 HLA I by patient’s T cells antibodies to HIP islet cells by patient’s NK cells 800 200 Baseline 1.5 600 150 HLA II 1.0 400 100 63 62 61 60 59 no killing 0.5 200 50 22 21 20 21 23 0 0 0.0 10 20 30 40 50 Baseline D7 D14 D21 D28 BL D7 D14 D21 D28 Hours -0.5 Baseline D28 200 D28 1.5 1.5 1.5 150 1.0 1.0 1.0 no killing no killing no killing 100 0.5 0.5 0.5 61 60 60 59 59 50 0.0 0.0 0.0 10 20 30 40 50 10 20 30 40 50 10 20 30 40 50 0 Hours Hours Hours -0.5 -0.5 -0.5 BL D7 D14 D21 D28 © 2020-2025 Sana Biotechnology. All rights reserved. 15 Spot Frequency Normalized Cell Index Normalized Cell Index IgG MFI IgM MFI Normalized Cell Index Normalized Cell Index
HIP islet cells overcome patient's allogeneic and autoimmune barrier still image before movie D7 sample: PBMC (containing all immune cell populations) Donor islet cells with NK cells plus serum (containing antibodies and complement) killing assay editing profile in column title Target: WT islet cell Target: HLAI/II dKO islet cell Target: HIP islet cell Adaptive immune Killing Innate immune Killing No immune killing Actual assay time = 4 hours. © 2020-2025 Sana Biotechnology. All rights reserved. 16
still image after movie © 2020-2025 Sana Biotechnology. All rights reserved. 17
SC451: A drug for the broad T1D population Make hypoimmune islet Manufacture Deliver as a 1 2 3 cells from stem cells at scale single therapy Graft site + CD47 MHC I MHC II SC451 program – HIP stem cell-derived islet cell therapy delivered with no immunosuppression © 2020-2025 Sana Biotechnology. All rights reserved. 18
Four major challenges to realizing the vision of SC451 1 2 3 4 Overcoming immune Differentiating PSCs into Generating a gene- Manufacturing enough rejection without islet cells at a purity, modified MCB from a GMP- product to treat the immunosuppression potency, and yield to compliant PSC line that is patients that need it enable clinical trial dosing genetically stable and We believe this challenge We are working on remains so after gene has now been solved Many groups have done this the challenges of editing and differentiation successfully and so has Sana manufacturing at scale into islet cells We have done it in research © 2020-2025 Sana Biotechnology. All rights reserved. 19
HIP-modified PSC differentiated islet cells transplanted into muscle persist & control blood glucose in mice for >15 months PSCs differentiated into HIP-modified PSC HIP-modified PSC islets persist islets at high purity islets produce human and control blood glucose (non-fasted blood glucose*) c-peptide** in vivo (performed at week 51) iPSC-islets Diabetic (STZ) control 600 ULOQ 2000 400 1500 Insulin Diabetic 1000 200 500 0 0 4 8 12 16 20 24 52566064 0 STZ Time post-transplant (weeks) Pre- Post- glucose glucose Ÿ Maintain normoglycemia (64+ weeks) Ÿ Secrete c-peptide in response to glucose Ÿ Retain strong expression of hCD47 Diabetic threshold at 250 mg/dL; data reported as mean ± S.E.M. **plasma human c-peptide after 5 hr fast (pre) and 30 min after I.P. 3 g/kg dextrose bolus (post); data is mean ± S.D. © 2020-2025 Sana Biotechnology. All rights reserved. 20 Human c-peptide (pM) Blood Glucose (mg/dL)
B-cells drive autoimmune disease in millions of patients >75 different types of autoimmune disorders with underlying B cell pathology and high unmet need • SLE • NMDAR encephalitis • Vasculitis (granulomatosis • Thrombocytopenic purpura with polyangiitis & microscopic • Amyloidosis >5M polyangiitis) • Systemic sclerosis 1 patients • Neuromyelitis optical spectrum • Autoimmune hemolytic anemia B-cell mediated • Pemphigus • Chronic immune demyelinating autoimmune • Relapsing and polyradiculoneuropathy diseases progressive MS • Immune-mediated necrotizing • Rheumatoid arthritis myopathy • Lupus nephritis • Membranous nephropathy Lupus Foundation of America • Sjögren’s syndrome estimates over a million people 2 have lupus in the US 1 2 Sana internal analysis; SciVida Autoimmune Factbook 2023, U.S; www.lupus.org/resources/how-many-people-have-lupus-in-the-united-states. © 2020-2025 Sana Biotechnology. All rights reserved. 21
Autologous CAR Ts have shown curative potential; allogeneic cells have inherent advantages Autologous CAR T CD19 Autologous CAR T treatment has Challenges 1 delivered long term, drug-free remissions Ÿ Difficult to scale SLEDAI-2K Urinary Protein Excretion Ÿ Prescription-to-infusion time over 4 weeks Ÿ Patients must be taken off anti-inflammatory drugs for apheresis and treatment Allogeneic CAR T Promise Ÿ Scalable Ÿ Available to patients off-the-shelf Ÿ No apheresis Allogeneic CAR Ts are the future 1 Muller F et al, NEJM 2024, Erlangen case series. © 2020-2025 Sana Biotechnology. All rights reserved. 22
Sana’s T cell manufacturing process provides high yields of successfully edited cells SC291: Highly efficient editing of cells Product ready when the patient needs it 1 100s of autoimmune patient batches/manufacturing run + CD47 + CAR MHC I ~85% full knock-out of MHC class I and II MHC II >99.5% TCR TCRα negative cells 1 100s of doses assumes an autoimmune dose consistent with public data on current autoimmune dose levels. © 2020-2025 Sana Biotechnology. All rights reserved. 23
SC291 can be safely administered and results in deep, dose-dependent B-cell depletion in oncology Deep B-cell depletion seen in NHL patients ARDENT Safety Data (N=16) 5000 Dose Level 3 Dose Level 4 300-006 (M5) 300-012 1000 300-007 (M3) Ÿ No cases of Grade 2 or higher CRS 103-002 (D28) 500 300-008 (M3) Ÿ 3 cases of Grade 1 CRS 300-010 (M3) 100 50 Ÿ No cases of ICANS 40 Ÿ 1 case of Grade 1 IEC-HS 30 20 10 LLOQ 0 D-5 D0 D1 D3 D6 D8 D10 D13 D16 D21 D28 M2 M3 M4 M5 Timepoint Data cutoff Nov 2024. Abbreviations: CRS, cytokine release syndrome; ICANS, Immune effector cell-associated neurotoxicity syndrome; IEC-HS, immune effector cell associated HLH-like syndrome. © 2020-2025 Sana Biotechnology. All rights reserved. 24 + CD19 Cell ABS (cells/µL)
SC291: GLEAM Phase 1 trial goals are to understand safety, dose, and early efficacy Allogeneic HIP CAR T cell + CD47 Ÿ Key features of Phase 1 trial (GLEAM) Ÿ Patients with refractory systemic lupus erythematosus and ANCA-associated MHC I vasculitis + CD19 CAR Ÿ Dose escalation study MHC II Ÿ Potential to expand beyond these indications over time Ÿ SC291 granted Fast Track designation in relapsed/refractory SLE TCRα Ÿ Trial enrolled first patients in 2024 An effective allogeneic CAR T offers potential to transform outcomes for patients © 2020-2025 Sana Biotechnology. All rights reserved. 25
Sana is pursuing in vivo engineering of CAR T cells using a fusosome vector system Delivery Expression Function Transduction of CD8 T cells Transgene integration and CAR expression Targeted cell killing B cell T cell Target cell killing CAR CAR Transgene T cell amplification for CAR expression CAR T cell Fusosome 2 1 CAR activity Fusosome performance • Expression/recognition • Transduction specificity • Amplification • Transduction efficiency • Target cell killing © 2020-2025 Sana Biotechnology. All rights reserved. 26
Fusosome technology: Cell-specific in vivo delivery Sana approach: Leverage insights from nature to deliver various payloads to specific cells without lymphodepletion G F Fusosome © 2020-2025 Sana Biotechnology. All rights reserved. 27
Potent and cell-specific in vivo delivery demonstrated with SG299 in GLP tox study 4 NHPs at each dose received single SG299 injection Potent transduction of No off-target transduction detected in + circulating CD8 T cells hepatocytes or gonadal cells Low dose High dose 0 -1 10 10 ON-TARGET Low dose Achieved in the absence of High dose -1 CAR-mediated amplification 10 (CAR is not NHP-reactive) -2 10 -2 10 -3 10 LOQ -3 NO LIVER NO TESTIS 10 OFF-TARGET OFF-TARGET -4 10 LOD 0 10 20 30 40 60 80 100 Day Avg ± SEM plotted. Note that any values BLOQ are not plotted. 2 vehicle-control monkeys were BLOQ. Abbreviations: BLOQ, below level of quantification; LOD, level of detection; LOQ, level of quantification. © 2020-2025 Sana Biotechnology. All rights reserved. 28 Bone marrow Liver left lobe Liver right lobe Lung caudal Lymph node draining CD8+ lymph node Spleen CD8+ spleen Heart ventricle Injection site Kidney left Kidney right Large intestine Pancreas Small intestine Testis Thymus Tonsils Heart atrium Spinal cord cervical Brain + CAR Vector Copy Per CD8 T Cell CAR Vector Copy Per Cell
Surrogate SG299 with additional component leads to T cell transduction, CAR expansion, and B-cell depletion Surrogate SG299 transduces T cells & expresses a CAR that recognizes NHP B cells + + CD8 CAR cells expand in circulation Deep B-cell depletion achieved in peripheral blood Control NHP 1 NHP 2 Control n=3 NHP 1 NHP 2 1000 50 800 40 600 30 400 20 200 10 0 0 -7 0 7 14 21 28 Pre 0 1 2 3 4 Study Day Study Week © 2020-2025 Sana Biotechnology. All rights reserved. 29 + % CAR Positive CD8 T Cells + CD20 Count/uL WB
Study shows B cell clearance in lymph nodes without lymphodepletion Anti CD20 staining of day 28 lymph node biopsy Control NHP 1 NHP 2 Brown indicates CD20 IHC staining; black reflects tattoo ink. © 2020-2025 Sana Biotechnology. All rights reserved. 30
SC262: Targets growing population of patients with inadequate response to CD19 therapy CD19 CAR T relapsed patients represent CD22 CAR T is a promising approach to 1 5 large and growing unmet need treat CD19 therapy failure Ÿ Autologous CD22 CAR T results in >50% CR rate in Estimated ~12,000 CD19 CAR failure DLBCL patients B cell malignancy patients treated with Ÿ High rates of non relapse mortality reported in long 2 CD19 CAR T in 2027 term follow up of autologous CD22 CAR T-treated Estimated ~35-40% patients • Potential of ~7,500 of CAR T patients CAR T failures 6 with durable Ÿ High rate of CRs also seen in CD19 failure ALL patients 2 annually in 2027 4 complete responses • Median survival of ~5 months post-CD19 3 CAR T therapy failure = 1,000 people 1 2 US, EU5, and Japan. Clarivate DRG NHL Market Forecast Nov 2021; 2027 Forecast is 2L+ LBCL patients; internal analysis of secondary EPI data. 3 4 5 ;5 6 Di Blasi et al. Blood.2022; DESCAR-T registry. DiBlasi et al. Blood. 2022: 2024 ASH Kramer et al. 2022 ASH Miklos/Stanford; 2018 Nature Med Fry, et al. © 2020-2025 Sana Biotechnology. All rights reserved. 31
SC262: VIVID Phase 1 trial goals are to understand safety, dose, and early efficacy Allogeneic HIP CAR T cell + CD47 Ÿ Key features of Phase 1 trial (VIVID) Ÿ CD19 CAR T exposed patients with relapsed and/or refractory NHL MHC I + CD22 CAR Ÿ Starting dose of 90 million CAR T cells MHC II Ÿ Expect to generate and share data Ÿ Safety and tolerability Ÿ Early response rates TCRα An effective allogeneic CAR T offers potential to transform outcomes for patients © 2020-2025 Sana Biotechnology. All rights reserved. 32
We anticipate meaningful clinical data in multiple diseases in 2025 and beyond Ÿ HIP platform shows ability to overcome allogeneic and autoimmune rejection in people across multiple cell types Ÿ Type 1 diabetes – all components for a curative therapy are now in place: Ÿ Patients have remained off insulin for over a decade after islet transplant (but with immunosuppression to date) Ÿ Stem cell-derived islets offer a more scalable solution (but with immunosuppression to date) Ÿ Have now shown that we can eliminate immunosuppression with HIP modifications Ÿ SC451, a HIP-modified stem cell-derived pancreatic islet therapy, contains all components and is advancing toward the clinic Ÿ SC291 leads to deep B-cell depletion and has significant potential in B-cell mediated autoimmune diseases. Ongoing GLEAM study Ÿ Fusogen platform offers the potential to treat B-cell mediated autoimmune diseases and B-cell cancers with NO lymphodepletion Ÿ SC262, a HIP-modified CD22 CAR T, has meaningful potential in treating CD19 CAR T relapsed patients. Ongoing VIVID study © 2020-2025 Sana Biotechnology. All rights reserved. 33
Sana pipeline positioned to deliver meaningful clinical data PRODUCT PRECLINICAL SANA’S CANDIDATE MECHANISM INDICATIONS IND-ENABLING PHASE 1 PHASE 2/3 RIGHTS Type 1 Diabetes 1 UP421 HIP primary islet cells T1D WW SC451 Stem-cell derived pancreatic islet cells T1D WW B-cell Mediated Autoimmune Diseases SC291 CD19-directed allo CAR T SLE GLEAM WW SC291 CD19-directed allo CAR T AAV WW GLEAM SC291 CD19-directed allo CAR T Other indications WW SG299 In vivo CD19-directed allo CAR T Autoimmune disease WW Oncology SC262 CD22-directed allo CAR T NHL (CD19 failures) WW VIVID Hematological SG299 In vivo CD19-directed allo CAR T WW malignancies 1 Investigator sponsored trial. Abbreviations: AAV, ANCA-associated vasculitis; SLE, systemic lupus erythematosus; NHL, non-Hodgkin lymphoma; SLE, systemic lupus erythematosus; T1D, type 1 diabetes; WW, worldwide. © 2020-2025 Sana Biotechnology. All rights reserved. 34
