SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction of
incorporation or organization)
|(Commission File Number)||(I.R.S. Employer|
|(Address of principal executive offices)||(Zip Code)|
Registrant’s telephone number, including
area code: (
(Former name or former address, if changed since last report)
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 (see General Instruction A.2. below):
|Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
Securities registered pursuant to Section 12(b) of the Act:
|Title of Each Class||Trading Symbol||Name of Exchange on Which Registered|
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 7.01||Regulation FD Disclosure|
On September 8, 2022, Century Therapeutics, Inc. (the “Company”) updated information reflected in a slide presentation, which is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. Representatives of the Company will use the updated presentation in various meetings with investors from time to time.
The information contained in this Item 7.01 (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section and shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
|Item 9.01||Financial Statements and Exhibits|
The following exhibit is being furnished herewith:
|99.1||Investor Presentation of Century Therapeutics, Inc., dated September 8, 2022|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document)|
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.
|CENTURY THERAPEUTICS, INC.|
|By:||/s/ Osvaldo Flores, Ph.D.|
|Name:||Osvaldo Flores, Ph.D.|
|Title:||President and Chief Executive Officer|
Date: September 8, 2022
Corporate Overview September 2022
2 Forward - looking statements This presentation contains forward - looking statements within the meaning of, and made pursuant to the safe harbour provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this document, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding possible or assumed future results of operations, business strategies, research and development plans, regulatory activities, market opportunity, competitive position and potential growth opportunities are forward - looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward - looking statements. In some cases, you can identify forward - looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward - looking statements in this presentation are only predictions. We have based these forward - looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward - looking statements speak only as of the date of this presentation and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among others: our ability to successfully advance our current and future product candidates through development activities, preclinical studies, and clinical trials; our reliance on the maintenance on certain key collaborative relationships for the manufacturing and development of our product candidates; the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates; the impact of the COVID - 19 pandemic, geopolitical issues and inflation on our business and operations, supply chain and labor force; the performance of third parties in connection with the development of our product candidates, including third parties conducting our future clinical trials as well as third - party suppliers and manufacturers; our ability to successfully commercialize our product candidates and develop sales and marketing capabilities, if our product candidates are approved; and our ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of our most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward - looking statements as predictions of future events. The events and circumstances reflected in our forward - looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward - looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward - looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Emerging leader in cell therapies for cancer Comprehensive iPSC cell platform For immune effector cells Technical Expertise Genetic and protein engineering, process development and immuno - oncology Foundation in Science Continuing investment in innovation drives R&D State - of - the - art GMP manufacturing facility Fully operational, enabling improved and faster product iteration Financial Strength Cash runway into 2025, Ended 2Q22 with cash, cash equivalents, and investments of $429.4M ~ 200 Employees including experienced leaders and entrepreneurs Emerging pipeline of candidates Product engine anticipated to deliver 5 INDs over the next 3 years; CNTY - 101 entering clinic 2H22 BMS Discovery Collaboration Initial focus on AML (CNTY - 104) and Multiple Myeloma (CNTY - 106)
Osvaldo (Lalo) Flores CEO Adrienne Farid COO Greg Russotti CTO Hy Levitsky President R&D Luis Borges CSO Michael Diem CBO Proven leadership team ® 4
6 Building a next generation allogeneic cell therapy platform Gene Editing • Proprietary gene editing platform • CRISPR MAD7 - derived gene editing for precise transgene integration Protein Engineering • Developing proprietary next - generation CARs • Universal tumor targeting platform iPSC Differentiation/Manufacturing • Scalable protocols and processes to produce highly functional iNK and iT cell products iPSC Reprogramming • Comprehensive collection of clinical grade lines (CD34+ HSC, αβ T cell , γδ T cell derived) Vertically integrated capabilities differentiate Century’s approach
7 Foundational investments in iPSC know - how and manufacturing Established in - house manufacturing accelerates learnings and enables faster product iteration • 53,000 ft 2 facility • Designed to produce multiple immune cell types • Two sites provides optionality and maximizes flexibility iPSC license and collaboration agreement established in 2018 • Access to clinical grade iPSC lines • Exclusive IP and know - how to generate immune effector cells using feeder - free methods (NK, T, Mac, DC) • FCDI GMP manufacturing capacity for Century’s product candidates • Leveraging two decades of research & investment at University of Wisconsin and FCDI
8 Multiple gene edits (KO/KI) iPSC bank Precision CRISPR MAD7 mediated sequential gene editing of iPSC cells generates uniform product candidates Engineered iPSC Master Cell Bank (MCB) Advantages of Century’s Platform P recise CRISPR mediated homology directed repair reduces off - target integration Stepwise and efficient gene editing avoids risky multiplex modification and structural variants Quality control through generation of homogenous MCB establishes genomic product integrity Manufacturing begins at the MCB, confirmed to be free from genetic aberrations Sequential selection steps iSPC Precision Engineering CRISPR - mediated HDR (MAD 7)
9 Allo - Evasion TM 1.0 designed to overcome 3 major pathways of host vs graft rejection 1. Deletion of β 2M, a protein required to express HLA - 1 on the cell surface prevents recognition by CD8 T cells 2. Knock out of CIITA eliminates HLA - II expression to escape elimination by CD4 T cells 3. Knock - in of HLA - E prevents killing by NK cells b 2M KO (HLA - I) HLA - E KI CIITA KO (HLA - II) CD8 + T Cell CD4 + T Cell NK cell 3 core edits disarm host cells from eliminating therapy
10 Allo - Evasion TM 3.0 Provides Additional Protection Against NK Cell Killing 1. Deletion of β 2M, a protein required to express HLA - 1 on the cell surface prevents recognition by CD8 T cells 2. Knock out of CIITA eliminates HLA - II expression to escape elimination by CD4 T cells 3. Knock - in of HLA - E prevents killing by NK cells 4. Knock - in of HLA - G prevents killing by NK cells b 2M KO (HLA - I) HLA - E KI CIITA KO (HLA - II) CD8 + T Cell CD4 + T Cell NK cell 4 core edits disarm host cells from eliminating therapy HLA - G KI
11 Expression of HLA - E + HLA - G further protects from NK cell killing HLA - E HLA - G NKG2A KIRs, LIRs Activating ligand Activating receptor Proof - of - Concept Study with HLA - I Null K562 Cells Engineered with HLA - E and HLA - G 0 . 1 2 5 0 . 2 5 0 . 5 1 2 4 8 1 6 3 2 0 20 40 60 80 100 Donor RC01 Ratio (E:T) % K i l l i n g Parental K562 HLA-G K562 HLA-E K562 HLA-E+G K562 The Combination of HLA - E + HLA - G Improved Protection to Killing by Allogeneic NK Cells • HLA - E and HLA - G engage different receptors on NK cells including NKG2A, KIRs, and LIRs • The expression of NKG2A, KIRs, and LIRs varies among NK cells from different donors Agglomerated Data from 22 NK Cell Donors N o e d i t H L A - G H L A - E H L A - E / G 0.0 0.2 0.4 0.6 0.8 1.0 R e l a t i v e c y t o l y s i s
12 Illustrative potential of Allo - evasion ۲ on cellular pharmacokinetics and multiple doses With Allo - Evasion TM engineering Initial dose Minimum threshold to maintain pharmacological pressure Repeat dose Repeat dose Without Allo - Evasion TM engineering Lack of durable responses seen to date in other allogeneic approaches likely due to rejection of the product
13 Common progenitor milestone enables cost, time efficiencies Multiple gene edits Engineered iPSC iNK cell iPSC bank Cell engineering Manufacturing Common Progenitor iNK 3.0 CD34 + HSC T cell Reprogramming Reprogramming Differentiation NK cell • iPSC cell bank with 12 core 3.0 gene edits introduced in 5 sequential steps • R esets product development starting point: accelerates and de - risks development candidate selection New Starting Point + CAR
15 iNK 3.0 common progenitor multiple new features for enhanced functionality Tumor cell killing Allo - Evasion TM Cell Fitness Imaging + Cytokine support + Safety switch iNK CP Boldface : iNK 3.0 - specific gene edits Common Progenitor Features ENGINEERING PROFILE Step Gene Edit Rationale 1 KO NKG2A Potential to block inhibitory signal KI IL15/IL15Ra Homeostatic cytokine support 2 KO B2M Allo - Evasion KI HLA - E - 2A - HLA - G Allo - Evasion 3 KO CIITA ex5 Allo - Evasion KI HSV - TK - 2A - PSMA Safety switch + cell tracer 4 KO CD70 Landing pad, potential to enhance cell fitness KI CD16 - 2A - NKG2D Ab targeting + Tumor stress ligands 5 INS CLYBL Safe harbor site KI CAR Tumor targeting CD16 NKG2D PSMA HLA - G HLA - E IL - 15/IL15RA HSV - TK Safety switch HLA - I KO HLA - II KO CD70 KO NKG2A KO
16 Century’s strategic vision for winning in solid tumors Building best - in - class γδ i T cell platform with up to 5 distinct tumor killing mechanisms CAR CD16 NKG2D Safety switch & tracer TCR UTRAP Tumor antigen/ TCR Stress ligands Antibody/tumor antigen ADCC Tumor antigen Non - HLA TCR target Cytokine support Allo - Evasion Enhanced fitness γδ iT cell
Pipeline and Franchises
18 Century’s emerging franchises B cell malignancies CNTY - 101 : Lead product candidate, CD19 targeted CAR - iNK • F irst product candidate to enter the clinic with edits designed to avoid 3 major pathways of rejection CNTY - 102 : First gd iT candidate, multi - specific (CD19 + CD79b) CAR - iT Discovery pipeline: Leverages iNK 3.0 platform Glioblastoma CNTY - 103 : CD133 CAR iNK 3.0 for recurrent GBM • Multi - tumor antigen targeting through combination approach addresses heterogeneity in GBM tumor cells Discovery pipeline: Exploring iNK 3.0 and γδ iT platforms Future candidate: • E xpected to be announced 4Q 2022 Discovery pipeline: Leverage γδ iT platform to target challenging solid tumors Solid tumors
Product iPSC Platform Targets Indications Expected IND Submission Discovery Preclinical Clinical Collaborator CNTY - 101 iNK CD19 B - Cell Malignancies Mid 2022 CNTY - 103 iNK CD133 Glioblastoma 2024 CNTY - 102 iT CD19 + CD79b B - Cell Malignancies 2024 CNTY - 104 iNK / iT Multi - specific Acute Myeloid Leukemia 2024 CNTY - 106 iNK / iT Multi - specific Multiple Myeloma 2024 Discovery Research Programs iNK / iT TBD Solid Tumors TBD iNK TBD Hematological Tumors 2023 Hematologic Tumors Solid Tumors Pipeline Product candidate pipeline across cell platforms and targets in solid and hematologic cancers
20 ELIPSE - 1: Phase 1 study vision CNTY - 101: differentiated next - gen CD19 targeted product CNTY - 101 First cell product candidate designed to avoid all major pathways of host v graft rejection Allo - Evasion TM edits Highly differentiated profile HLA - I Knockout IL - 15 HLA - II Knockout CD19 CAR HLA - E Safety Switch * Subject to FDA approval Explore 1 to 2 cycles* up to 6 doses with single LD conditioning Effect of Allo - Evasion TM on iNK persistence after multiple doses ELiPSE - 1 trial to initiate imminently Day 1 LD Day 50 Subsequent dose(s) without additional LD* Clinically meaningful and platform validating data generated from ELiPSE - 1 Schedule B ≥1bn cells/dose
21 Century’s partnered programs Acute Myeloid Leukemia CNTY - 104: Multi - specific iT or iNK candidate Potential for controlled dosing and persistence to eliminate blasts while mitigating toxicity to the marrow Multiple Myeloma CNTY - 106: Multi - specific iT or iNK candidate Address relapses to current CAR T therapies associated with residual to negative BCMA expressing cells Bristol Myers Squibb brings complementary technologies and capabilities in competitive indications. Bristol - Myers Squibb collaboration includes option to add 2 additional programs in either hematological malignancies or solid tumors.
22 Anticipated catalysts over next 12 months Underpinned by strong balance sheet with platform synergies and operational excellence CNTY - 101 Becoming clinical stage biotech company with most advanced allogeneic cell therapy • Phase 1 (ELiPSE - 1) start in B - cell malignancies (2H22) γδ iT Platform Leveraging the comprehensive end - to - end platform • γδ iT pre - clinical data (4Q22) Disclosures 5 INDs anticipated over next 3 years • Solid tumor candidate expected to be announced (4Q22) iNK 3.0 Common Progenitor Creating platform efficiencies • Select additional candidate based on iNK 3.0 (YE22) – disclose data at future medical meeting • CNTY - 103 development candidate (2023)