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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): May 10, 2022

 

 

 

Century Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-40498   84-2040295
(State or other jurisdiction of
incorporation or organization)
  (Commission File Number)   (I.R.S. Employer
Identification No.)

 

3675 Market Street

Philadelphia, Pennsylvania

  19104
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (267) 817-5790

 

Not Applicable

(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
Common Stock, par value $0.0001 per share   IPSC   Nasdaq Global Select Market

 

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 x

 

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 8.01 Other Events

 

On May 10, 2022, Century Therapeutics, Inc. (the “Company”) updated information reflected in a slide presentation, which is attached hereto 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.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit
No.
  Document
99.1   Investor Presentation of Century Therapeutics, Inc., dated May 10, 2022
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.

 

  CENTURY THERAPEUTICS, INC.
     
  By: /s/ Osvaldo Flores, Ph.D.
  Name: Osvaldo Flores, Ph.D.
  Title: President and Chief Executive Officer
Date: May 10, 2022    

 

 

 

 

Exhibit 99.1

 

1 May 10, 2022 B of A SECURITIES 2022 HEALTHCARE CONFERENCE

 

 

2 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 c ond itions, including but not limited to, statements regarding possible or assumed future results of operations, business strategies, research and development plans, regulatory activities, market oppo rtu nity, 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,” “projec t,” “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 predictio ns. 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, financ ial 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 w hic h 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 devel opm ent 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 t imi ng, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates; the impact of the COVID - 19 pandemic 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 thir d - p arty 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 fi lings 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 circumstanc es 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 operat e 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 fa ce. 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, cha nged circumstances or otherwise.

 

 

3 3 Future Vision Century is developing transformative allogeneic cell therapies Establish franchises in B cell malignancies, GBM, solid tumor indications World - class cell engineering and manufacturing capabilities Develop best - in - class iPSC - derived iNK and iT cell platforms Financial strength maintained by platform synergies, efficiencies

 

 

4 4 ELIPSE - 1: PHASE 1 STUDY GOALS • Dose escalation with multiple doses and single lymphodepletion conditioning regimen • IND submission on track for mid - 2022 to advance CNTY - 101 into Phase 1 clinical trial CNTY - 101: NEXT GENERATION CD19 TARGETED PRODUCT CNTY - 101 HLA - I Knockout IL - 15 HLA - II Knockout CD19 CAR Allo - Evasion TM edits HLA - E HIGHLY DIFFERENTIATED PROFILE Safety Switch First cell product candidate with 6 gene edits introduced with CRISPR - HDR Day 1 LD Day 50 Subsequent dose(s) without additional LD Clinically meaningful and platform validating data generated from ELiPSE - 1 Schedule B * Subject to FDA approval ≥1bn cells/dose

 

 

5 5 COMMON PROGENITOR ENABLES EFFICIENT PIPELINE EXPANSION iNK 1.0 iNK 3.0 Common Progenitor Candidate 1 Candidate 2 Candidate 3 iNK 3.0 common progenitor platform incorporates multiple features: • Additional Allo - Evasion edits • Additional innate killing potential • Additional anti - cancer targeting option • Cytokine support + CAR 2

 

 

6 6 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 + EGFR Glioblastoma 2023 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 / iT TBD Hematological Malignancies TBD Hematologic Tumors Solid Tumors Product candidate pipeline across cell platforms and targets in solid and hematologic cancers PIPELINE

 

 

7 7 CENTURY THERAPEUTICS’ UNIQUE INVESTMENT OPPORTUNITY We are developing a portfolio of potentially best - in - class, differentiated allogeneic cell therapies that deliver durable responses We are leveraging our iNK and δγ iT cell platforms to tackle tumors with unmet medical need Our comprehensive iPSC - based platform is in place, allowing for rapid iteration We are well capitalized with platform synergies and operational excellence to advance our portfolio and pipeline in 2022

 

 

8 THANK YOU