UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 1.01 Entry into a Material Definitive Agreement.
On January 7, 2022 (the “Effective Date”), Sana Biotechnology, Inc. (the “Company”) entered into a Patent License Agreement (the “Agreement”) with the U.S. Department of Health and Human Services, as represented by The National Cancer Institute, an institute of the National Institutes of Health (the “NIH”), pursuant to which the NIH granted to the Company an exclusive, worldwide, commercial license under certain patent rights related to certain fully-human anti-CD22 binders and CD22 CAR constructs comprising such binders (the “Licensed Patent Rights”) for use in certain in vivo gene therapy and ex vivo allogeneic CAR T cell applications for B cell malignancies. The license grant is subject to customary statutory requirements and reserved rights as required under federal law and NIH requirements. The Company has the right to grant sublicenses under the Licensed Patent Rights with the NIH’s prior consent.
Pursuant to the Agreement, the Company agreed to pay to the NIH an upfront payment of $1.0 million. Additionally, the Company will be obligated to pay to the NIH (i) up to an aggregate of $9.6 million in specified regulatory, developmental and commercial milestone payments with respect to each product developed through exploitation of the Licensed Patent Rights (each, a “Licensed Product”) and (ii) a payment of $1,000,000 upon the assignment of the Agreement to an affiliate upon a change of control of the Company. In addition, the Company is obligated to pay to the NIH (i) a royalty on net sales of Licensed Products in the low-single digits, subject to reduction in certain circumstances, and subject to certain annual minimum royalty payments, and (ii) a percentage, ranging from the mid-single digits to mid-teens, of revenues from sublicensing arrangements. Additionally, if the Company is granted a priority review voucher by the U.S. Food and Drug Administration with respect to a Licensed Product, the Company will be obligated to pay to the NIH the greater of (i) $5,000,000 or (ii) a percentage in the mid-single digits of any consideration received for the sale, transfer or lease of such priority review voucher. The Company is also obligated to pay to the NIH a percentage in the low-single digits of the consideration received by the Company for any assignment of the Agreement to a non-affiliate.
The Company is obligated to use commercially reasonable efforts to exploit, and make publicly available, inventions developed by the exploitation of the Licensed Patent Rights, including Licensed Products.
Unless earlier terminated by either party, the Agreement will terminate upon expiration of the last-to-expire valid claim in the Licensed Patent Rights. The NIH may terminate the Agreement with written notice for the Company’s material breach if the Company fails to timely cure such breach or upon certain insolvency events involving the Company. In addition, the NIH may terminate or modify the Agreement, at its option, if the NIH determines that such termination or modification is necessary to meet the requirements for public use specified by federal regulations issued after the effective date of the Agreement, and these requirements are not reasonably and timely satisfied by the Company. The Company may terminate the Agreement or any licenses in any country or territory upon 60 days’ prior written notice.
The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which the Company plans to file as an exhibit to its Annual Report on Form 10-K for its fiscal year ended December 31, 2021.
Item 7.01 Regulation FD Disclosure.
The Company intends to present an updated corporate presentation (the “Corporate Presentation”) at the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022. 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 under Item 7.01 of this Current Report and Exhibit 99.1 to this Current Report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“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 8.01 Other Events.
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On January 11, 2022, the Company issued a press release announcing the Agreement, described above under Item 1.01 of this Current Report. A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
See the Exhibit Index below, which is incorporated by reference herein.
EXHIBIT INDEX
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99.1 |
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99.2 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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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 thereunto duly authorized.
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Sana Biotechnology, Inc. |
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Date: January 11, 2022 |
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By: |
/s/ James J. MacDonald |
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James J. MacDonald |
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Executive Vice President and General Counsel |
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Corporate Presentation January 2022 Exhibit 99.1
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 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 Quarterly Report on Form 10-Q dated November 8, 2021. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason. Cautionary Note Regarding Forward-Looking Statements
Ability to modify the genome and use engineered cells as medicines has the potential to be one of the most important advances in healthcare over the next several decades: Nearly every disease is caused by damage to or dysfunction of a cell Sana’s ambition is to repair or replace any cell in the body Platform progress, broad capabilities, and strong balance sheet enable us to execute on a broad vision: Goal: allo T and in vivo CAR T INDs this year with 2-3 INDs per year going forward Building expertise in key areas: delivery of genetic material, gene modification, immunology, biology, and manufacturing $866M as of the end of the third quarter 2021 Sana Biotechnology Engineered Cells as Medicines
Sana goal: Repair cells in the body when possible or replace them when needed Deliver any payload… (DNA, RNA, protein, organelle, integrating vs non-integrating) To any cell… (unlimited volume of distribution) In a specific… (e.g., just T cell) And repeatable way (limit immunogenicity) Manufacture any cell at scale… That engrafts… (the right cell in the right environment) Functions… (understand exact phenotype desired) And persists (overcome immune rejection and cellular signaling, such as apoptotic signaling)
Sana’s platforms, technology, and programs 1Ornithine transcarbamylase deficiency
Hypoimmune technology: Protecting cells from immune rejection
Hypoimmune cells evade rejection from the adaptive and innate immune system in mice Evade the adaptive immune system Deuse T, …, Schrepfer S. Nat Biotechnology. 2019; 37:252-258 T cell Activation (ELISPOT) No systemic T cell activation with HIP cell transplantation IgM Binding (FACS) No binding of donor-specific antibodies against HIP cells Evade the innate immune system NK Cell Killing No NK cell killing of HIP cells Wildtype Unmodified Cells No killing of unmodified cells by NK cells MHC Class I/II Disruption Killing of partially edited iPSC; HLA I/II knockout by NK cells MHC Class I/II Disruption & CD47 Overexpression No killing of HIP cells by NK cells Representative of results across 5 mice for the unmodified arm and across 6 mice for the hypoimmune arm. Hypoimmune iPSC Unmodified iPSC
Hypoimmune cells survive in vivo in NHP while unmodified iPSCs get rejected A A CO, cross over; Txp, transplant NHP unmodified iPSCs (wt) & NHP hypoimmune iPSCs (HIP) were transplanted into 8 allogeneic recipients Representative of results across 4 NHPs per arm. B Representative of results across 4 NHPs per arm.
T cell Activation (ELISPOT) No systemic T cell activation by hypoimmune cells IgM Production (ELISA) Implantation of hypoimmune cells does not cause activation of antibody production Hypoimmune cells do not activate the “missing self” response from the NK cells Anti-CD47 safety switch Killing by NK Cells Transplantation of NHP iPSCs into allogeneic NHPs: immune evasion is achieved even after prior sensitization WT HIP MHC-I/II KO iPSC Hypoimmune iPSC Killing due to missing self No killing Anti-CD47 safety switch results in killing Hypoimmune cells evade rejection from the adaptive and innate immune system in NHPs Representative of results across 4 NHPs per arm. Hypoimmune iPSC Unmodified iPSC
Sana is pursuing a broad ex vivo cell engineering strategy T cells Pancreatic islets Glial progenitor cells Cardiomyocytes Differentiate pluripotent stem cells with hypoimmune edits Programs that benefit from, but do not require hypoimmune
Significant unmet need in B cell malignancies and multiple myeloma in the US and EU alone: ~250,000 new cases annually1 Est. 100,000 deaths annually1 <10,000 patients have been treated with CAR T therapy to date2 Of those treated, many do not respond and many relapse Manufacturing and access challenges remain for many patients High unmet need remains for blood cancers 1World Health Organization, GLOBOCAN 2020 2Financial Reports, through Q3 2021; Evaluate Pharma, through Q3 2021
Sana’s hypoimmune allo T is potentially best-in-class GvHD, graft versus host disease; HvGD, host versus graft disease.
Day 0 Day 3 start of CAR dosing Day 7 Day 15 Untreated Day 23 Day 27 HIP CAR T cells CD19 HIP CAR T cells clear tumor in vivo
Clinical study shows CD22 CAR T efficacy in treating relapsed lymphoma after prior CD19 CAR T therapy Miklos et al, ASH 2021 Blood 2021 Apr 29;137(17):2321-2325. doi: 10.1182/blood.2020009432. Minimal ICANS / CRS observed across dose levels Miklos et al, ASH 2021 Total is a combination of DL1 and DL2
Expect to file our first allo T IND targeting CD19 as early as this year CD19/CD22 dual targeting offers potential of higher and more durable complete response rates Fully-human, clinically validated CD22 CAR with potential to address CD19 CAR T failures Fully-human, clinically validated BCMA CAR to potentially treat multiple myeloma Targets beyond CD19, CD22, and BCMA Best-in-class, broadly accessible allogeneic CAR T cells
Large unmet need remains Disease where destruction of insulin-producing beta cells in the pancreas results in inability to control blood glucose 1.6M patients with type 1 diabetes in the US and 2.4M in Europe2; 51k new patients/year combined3 Long-term complications: end-organ damage, including heart attack, stroke, retinopathy, and nephropathy Type 1 diabetes represents a large unmet need with a loss of ~15 years of life1 1Rawshani et al, Lancet 2018 2Centers for Disease Control and Prevention, Diabetes Report, 2017-2018 3National Institutes of Health, Health Promot Perspect 2020 Our goal is to produce hypoimmune beta cells that evade the immune system and normalize glucose
Progress toward turning beta cells into medicines Make functional beta cells from iPSCs cells Hide beta cells from allogeneic rejection Hide beta cells from autoimmune reaction Create GMP supply chain
Stem cell-derived pancreatic islet cells lead to robust function Superior insulin secretion and faster kinetics in vitro Robust rescue of type 1 diabetes mouse model
Hypoimmune pancreatic islet cells evade immune detection and regulate glucose levels Glucose levels stay elevated Allogeneic human hypoimmune islet cells Glucose levels normalized Allogeneic human unmodified islet cells
Hypoimmune pancreatic islet cells evade autoimmune killing in testing of blood from type 1 diabetic patients Unmodified islet cells Hypoimmune islet cells Serum from healthy volunteers or type 1 diabetics Antibodies from type 1 diabetic sera bind to unmodified islets, but not HIP islet cells Unmodified Islet Cells HIP Islet Cells
Robust GMP supply chain required to use iPSC-based therapies as medicines 1 2 3
Fusosome technology: Development of cell-specific in vivo delivery platform Source: CDC website 3 2 1 Sana approach: Leverage insights from nature to deliver various payloads to specific cells Fusosome
In vivo cell engineering: Creating targeted medicines across a diverse set of cell types T cells Hepatocytes Hematopoietic stem cells
High unmet need remains for blood cancers Current ex vivo approaches have limitations Fusogen platform offers potential to overcome these limitations
T cell fusosome carrying CAR construct infused into patient CAR activity Expression/recognition Amplification Target cell killing Target cell killing Specificity CD4/CD8 T cell transduction Expression Transgene integration and CAR expression Function Targeted cell killing T cell Fusosome Cancer cell CAR T cell 2 Fusosome performance Transduction specificity Transduction efficiency 1
IV administration of CD19 CAR delivered by fusosome can clear B cell tumors in humanized mice comparably to ex vivo CD19 CAR T CD19 CAR delivered by fusosome: in vivo CD19 CAR T: ex vivo Saline CD19 CAR T
Sana aspiration: Engineered cells as medicines Address obstacles to using engineered cells as medicines Validate platforms and create important medicines Hypoimmune allo CD19 CAR T Fusosome for CD19 CAR T in vivo Unlock the potential of engineered cells as medicines in multiple diseases Hypoimmune cells for: Cancer Diabetes Heart disease CNS disorders Fusosomes delivering payloads for other diseases
Exhibit 99.2
Sana Biotechnology Obtains Exclusive License from
National Institutes of Health for CD22 CAR Construct
License will enable Sana’s in vivo and ex vivo engineered T cell programs for B cell malignancies
Technology expected to help address key relapse challenges for
CD19-directed CAR T cell therapies
SEATTLE — January 11, 2022 — Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, today announced that the company entered into an agreement with the National Cancer Institution (NCI), an institute of the National Institutes of Health (NIH), for worldwide exclusive commercial rights to the NIH’s CD22 chimeric antigen receptor (CAR) with a fully-human binder for use in certain in vivo gene therapy and ex vivo allogeneic CAR T applications for B cell malignancies.
Engineered CAR T cell therapies for B cell malignancies use binders to target proteins expressed on the surface of B cells. One such protein, CD19, has been the target of all approved autologous CAR T therapies for B cell lymphoma and B cell acute lymphoblastic leukemia to date. Unfortunately, incomplete responses or relapses occur in over 50% of CD19 CAR T-treated patients, often due to CD19 antigen loss. CD22, which is also a B cell surface protein, has emerged as an alternative to address failure to achieve durable complete responses with CD19-directed CAR T therapy. Multiple academic clinical trials using this CD22 CAR have shown complete responses in a substantial number of patients in the relapse setting after treatment with a CD19-directed CAR T therapy for patients with B malignancies.
“We are thrilled to enter an agreement with the NIH for an exclusive license to this fully-human CD22 CAR, particularly given the clinical data with this specific construct to date. One of Sana’s primary goals has been to meaningfully expand the number of patients that benefit from CAR T therapies, with an initial focus on B cell malignancies, including leukemia and lymphoma,” said Terry Fry, M.D., Sana’s Head of T Cell Therapeutics. “Combining this CD22 CAR with Sana’s platforms gives us the potential to improve the overall rate of durable complete responses for patients with B cell malignancies – including non-Hodgkin lymphoma, chronic lymphocytic leukemia, and acute lymphoblastic leukemia – and expand the number of patients who can receive these therapies.”
Under the terms of the agreement, Sana agreed to pay the NIH an upfront amount, certain milestone payments, and royalties on net sales of royalty-bearing products.
About Sana Biotechnology
Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are more than 350 people
working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, Cambridge, and South San Francisco. For more information about Sana Biotechnology, please visit https://sana.com/.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about Sana Biotechnology, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the Company’s vision, progress, and business plans; expectations for its development programs, product candidates and technology platforms; expectations with respect to the use and benefits of the technology; the potential of CD22 as an alternative target for B cell malignancies; the potential efficacy of CD22 in vivo gene therapy and ex vivo allogeneic CAR T applications; the potential benefits of combining the technology with the Company’s platforms; and the Company’s potential milestone and royalty obligations. All statements other than statements of historical facts contained in this press release, 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 and clinical trials, as well as the economic, market and social disruptions due to the ongoing COVID-19 public health crisis. 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 but not limited to its Annual Report on Form 10-K dated March 24, 2021 and Quarterly Report on Form 10-Q dated November 8, 2021. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.
All product and company names herein may be trademarks of their registered owners.
Investor Relations & Media:
Nicole Keith
investor.relations@sana.com
media@sana.com