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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): November 9, 2023

 

 

 

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.)

 

25 North 38th Street, 11th Floor

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 2.02 Results of Operations and Financial Condition

 

On November 9, 2023, Century Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2023. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

The information contained in this Item 2.02 (including Exhibit 99.1) is being furnished and 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 and shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 7.01 Regulation FD Disclosure

 

On November 9, 2023, the Company updated information reflected in a slide presentation, which is attached as Exhibit 99.2 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 99.2) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section and shall not be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit
No.
  Document
     
99.1   Press Release of Century Therapeutics, Inc., dated November 9, 2023
     
99.2   Investor Presentation of Century Therapeutics, Inc., dated November 9, 2023
     
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/ Gregory Russotti, Ph.D.
  Name: Gregory Russotti, Ph.D.
  Title: Interim President and Chief Executive Officer

 

Date: November 9, 2023

 

 

 

 

Exhibit 99.1 

 

 

 

Century Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Updates

 

- Brent Pfeiffenberger, Pharm.D., MBA, appointed Chief Executive Officer of Century Therapeutics -

 

- Initial data from the ongoing Phase 1 ELiPSE-1 trial evaluating CNTY-101 in relapsed or refractory CD19 positive B-cell lymphomas to be presented at the American Society of Hematology (ASH) Annual Meeting -

 

- Announced expanded license agreements with FUJIFILM Cellular Dynamics (FCDI) for the development and commercialization of iPSC-derived cell therapies in autoimmune and inflammatory diseases -

 

- Ended third quarter 2023 with cash, cash equivalents, and investments of $284.3 million; Cash runway into 2026 -

 

PHILADELPHIA, November 9, 2023 -- Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, today reported financial results and business highlights for the third quarter ended September 30, 2023.

 

“The last several months have been marked by immense progress for Century, and we are thrilled to welcome Brent to the team as our new leader at this exciting period in the Company’s history,” said Joe Jimenez, Chairman of the Board of Directors of Century. Greg Russotti, Interim Chief Executive Officer, Century Therapeutics added, “We continued to advance our Phase 1 ELiPSE-1 trial evaluating CNTY-101 in relapsed or refractory CD19 positive B-cell lymphomas. Building on the exciting case study featured in our ASH abstract earlier this month, we look forward to sharing additional data in December which we believe continue to support the potential for a multi-dosing strategy for CAR iNK enabled by Allo-Evasion™.”

 

Dr. Russotti added, “Furthermore, we were extremely excited to announce this morning that we have expanded our license agreements with our partners at FCDI. These expanded agreements provide us new and continued access to technology that we believe will aid in our mission to bring curative cell therapy products to patients in need, including patients with autoimmune and inflammatory diseases.”

 

Business Highlights and Upcoming Milestones

 

·This morning, Century announced the appointment of Brent Pfeiffenberger, Pharm.D., MBA, as Chief Executive Officer and member of the Board of Directors, effective December 4, 2023. He brings to Century over 20 years of broad-ranging global leadership experience across the healthcare industry, most recently serving as Chief Operating Officer at Neogene Therapeutics. Also effective December 4, 2023, Greg Russotti, Ph.D., who has served as Century’s Interim Chief Executive Officer since April 2023, will assume the role of Chief Technology and Manufacturing Officer, an expanded role from his previous position as Chief Technology Officer.

 

 

 

 

 

·During a poster session at the upcoming ASH Annual Meeting being held December 9-12 in San Diego, the Company will present initial data from the ongoing first-in-human Phase 1 ELiPSE-1 trial of CNTY-101 in relapsed/refractory CD19 positive B-cell lymphomas. As previously announced, preliminary clinical data from a case study featured in the recently published ASH abstract shows a complete response maintained in a Dose Cohort 1 (100 million cell dose level) patient with high risk relapsed/refractory follicular lymphoma following completion of four 28-day cycles of CNTY-101, the two most recent of which did not include lymphodepletion. Updated data to be announced in December will include additional results from patients treated in Dose Cohort 1 as of a more recent cutoff date, as well as preliminary data from patients in Dose Cohort 2 (300 million cell dose level).

 

·This morning, Century and FUJI Cellular Dynamics (FCDI) announced that they have entered into a worldwide license agreement whereby FCDI will grant the Company non-exclusive licenses for certain patent rights and know-how related to cell differentiation and reprogramming for the development and commercialization of iPSC-derived therapies for the treatment of autoimmune and inflammatory diseases. The Company also shared that it expanded its existing 2018 license agreement with FCDI related to the development and commercialization of iPSC-derived cancer immunotherapeutics to also include inflammatory and autoimmune diseases.

 

Third Quarter 2023 Financial Results

 

·Cash Position: Cash, cash equivalents, and investments were $284.3 million as of September 30, 2023, as compared to $367.4 million as of December 31, 2022. Net cash used in operations was $61.8 million for the nine months ended September 30, 2022 compared to net cash provided by operations of $37.0 million for the nine months ended September 30, 2022 (which includes deferred revenue from the Bristol Myers Squibb (BMS) collaboration of $118.5 million).
   
 ·Collaboration Revenue: Collaboration revenue generated through the Company’s collaboration, option, and license agreement with BMS was $0.1 million for the three months ended September 30, 2023 compared to $2.2 million for the same period in 2022. Revenue recognized under the collaboration agreement fluctuates based on the amount and timing of expenses incurred under the agreement.

 

·Research and Development (R&D) expenses: R&D expenses were $22.8 million for the three months ended September 30, 2023 compared to $25.9 million for the same period in 2022. The decrease in R&D expenses was primarily due to the Company’s 2023 reorganization and reprioritization of early-stage programs and discovery platforms as well as a decline in sponsored research activities.

 

·General and Administrative (G&A) expenses: G&A expenses were $9.0 million for the three months ended September 30, 2023, compared to $8.1 million for the same period in 2022. The increase was primarily due increases in stock-based compensation and recruiting fees.

 

· Net loss: Net loss was $32.7 million for the three months ended September 30, 2023, compared to $30.7 million for the same period in 2022.

 

 

 

 

 

Financial Guidance

 

· The Company expects full year GAAP Operating Expenses to be between $135 million and $145 million including non-cash stock-based compensation expense of $12 million to $17 million.

 

· The Company expects its cash, cash equivalents, and investments will support operations into 2026.

 

About Century Therapeutics

 

Century Therapeutics (NASDAQ: IPSC) is harnessing the power of adult stem cells to develop curative cell therapy products for cancer and autoimmune and inflammatory diseases that we believe will allow us to overcome the limitations of first-generation cell therapies. Our genetically engineered, iPSC-derived iNK and iT cell product candidates are designed to specifically target hematologic and solid tumor cancers with a broadening application to inflammatory and autoimmune diseases. We are leveraging our expertise in cellular reprogramming, genetic engineering, and manufacturing to develop therapies with the potential to overcome many of the challenges inherent to cell therapy and provide a significant advantage over existing cell therapy technologies. We believe our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of care for cancer and autoimmune and inflammatory diseases. For more information on Century Therapeutics please visit www.centurytx.com.

 

 

 

 

 

Century Therapeutics Forward-Looking Statement

 

This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our clinical development plans and timelines, 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 press release 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 press release 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 dependence on the success of our lead product candidate, CNTY-101, our ability to obtain FDA acceptance for our future IND submissions and commence clinical trials on expected timelines, or at all; our reliance on the maintenance of 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 effects of the COVID-19 pandemic, geopolitical issues, banking instability 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 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; our ability to recruit and maintain key members of management 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.

 

For More Information:

 

Investors and Media: Melissa Forst/Maghan Meyers – century@argotpartners.com

 

 

 

 

 

Century Therapeutics, Inc

Condensed Balance Sheets

(unaudited, in thousands)

 

   September 30,   December 31, 
  2023   2022 
Assets        
Current Assets:         
Cash and cash equivalents  $55,307   $84,265 
Short-term investments   114,198    231,233 
Prepaid expenses and other current assets   4,198    4,223 
Total current assets   173,703    319,721 
Property and equipment, net   81,993    82,785 
Operating lease right-of-use assets, net   24,551    28,945 
Long-term investments   114,762    51,854 
Other long-term assets   2,542    3,239 
Total assets  $397,551   $486,544 
           
Liabilities, convertible preferred stock, and stockholders' equity          
Current liabilities:          
Accounts payable  $5,927   $5,454 
Accrued expenses and other liabilities   10,637    10,707 
Long-term debt, current   -    6,502 
Deferred revenue, current   3,871    7,154 
Total current liabilities   20,435    29,817 
Operating lease liability, noncurrent   45,535    38,698 
Long-term debt, net   -    3,739 
Other long-term liabilities   201    718 
Deferred revenue   112,150    110,834 
Total liabilities   178,321    183,806 
Stockholders' equity          
Common stock   6    6 
Additional paid-in capital   836,901    824,292 
Accumulated deficit   (616,373)   (519,098)
Accumulated other comprehensive loss   (1,304)   (2,462)
Total stockholders' equity   219,230    302,738 
Total liabilities and stockholders' equity  $397,551   $486,544 

 

 

 

 

 

Century Therapeutics, Inc

Condensed consolidated statements of operations

(unaudited, in thousands, except share and per share amounts)

 

   Three months Ended   Nine months Ended 
   September 30,   September 30,   September 30,   September 30, 
   2023   2022   2023   2022 
Collaboration Revenue  $148   $2,224   $1,967   $4,678 
                     
Operating Expenses                    
Research and development  $22,788   $25,898   $70,414   $71,588 
General and administrative   8,986    8,064    26,117    23,615 
In-process research and development   4,000    -    4,000    10,000 
Impairment on long-lived assets   -    -    4,220    - 
Total operating expenses  $35,774   $33,962   $104,751   $105,203 
                     
Loss from operations   (35,626)   (31,738)   (102,784)   (100,525)
                     
Interest expense   -    (373)   (540)   (1,017)
Interest income   3,486    1,411    9,167    2,370 
Other income, net   12    (24)   (368)   (19)
Loss before provision for income taxes  $(32,128)  $(30,724)  $(94,525)  $(99,191)
Provision for income taxes   (592)   (25)   (2,750)   (59)
Net Loss  $(32,720)  $(30,749)  $(97,275)  $(99,250)
                     
Unrealized loss on investments   (95)   (165)   1,157    (2,931)
Foreign currency translation adjustment   (2)   (5)   (1)   (23)
Comprehensive loss   (32,817)   (30,919)   (96,119)   (102,204)
                     
Net loss per common share - Basic and Diluted   (0.55)   (0.53)   (1.65)   (1.72)
                     
Weighted average common shares outstanding   59,448,229    57,973,541    59,087,374    57,573,406 

 

 

 

Exhibit 99.2

 

Corporate Overview November 2023

 

 

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.

 

 

3 Investment thesis Next generation platforms for iNK and gamma delta iT candidates Foundational investments in iPSC technology, genetic editing, and manufacturing Experienced team in R&D, immuno - oncology, manufacturing and commercialization Exemplified by execution of ongoing first - in - human Phase 1 ELiPSE - 1 trial Well capitalized with cash runway into 2026 $284.3M in cash, cash equivalents and investments at the end of 3Q23; operational efficiencies designed to enable delivery on key milestones, clinical data

 

 

iPSC Platform

 

 

5 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

 

 

6 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 • Access to clinical grade iPSC lines • Exclusive IP and know - how to generate immune effector cells using feeder - free methods (NK, T, Mono/ Mac, DC) • Expanded to include development and commercialization of cell therapies for the treatment of autoimmune and inflammatory diseases (2023) • FCDI GMP manufacturing capacity for Century’s product candidates • Leveraging two decades of research & investment at University of Wisconsin and FCDI

 

 

7 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)

 

 

8 Potential to drive durable responses with engineering to resist immune rejection Allo - Evasion TM edits + repeat dosing = potential greater durability Next - wave of allogeneic cell therapies must solve for challenge of rejection With Allo - Evasion TM engineering Without Allo - Evasion TM engineering

 

 

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 improves protection against 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

 

 

Pipeline

 

 

13 Product iPSC Platform Targets Indications Discovery Preclinical Clinical Collaborator P1 P2 P3 CNTY - 101 iNK CD19 B - Cell Malignancies CNTY - 102 iT CD19 + CD22 B - Cell Malignancies CNTY - 107 iT Nectin - 4 Solid Tumors Programs in Collaboration CNTY - 104 iNK/iT Multi - specific Acute Myeloid Leukemia CNTY - 106 iNK/iT Multi - specific Multiple Myeloma Research Programs Discovery iNK/iT TBD Hematological / Solid Tumors Pipeline Product candidate pipeline across cell platforms and targets in solid and hematologic cancers Hematologic Tumors Solid Tumors

 

 

CNTY - 101 Clinical Program

 

 

15 CNTY - 101 aims to deliver durable responses in R/R B - cell NHL via repeat dosing facilitated by Allo - Evasion TM R/R: relapsed or refractory, NHL: non - Hodgkin lymphoma, CAR - T: chimeric antigen receptor T cell therapy Potential solution from Century’s platform: • Off - the - shelf product offers immediate access and consistency • Multiple doses to increase pharmacological pressure to increase durability • Host rejection addressed by Allo - Evasion TM edits Unmet need: • Autologous CD19 CAR - T is curative in 40 percent of patients • Autologous CD19 CAR - T access is limited and/or can fail in manufacturing as quality is dependent on patient - derived starting material • Limited options and poor prognosis for patients who fail autologous CAR - T Aim: extending the period of pharmacologic pressure on tumor cells

 

 

16 Delivering on our vision to change the cell therapy treatment paradigm • Goal to improve durability, tolerability and ease of outpatient administration • Potential to e liminate need for lymphodepletion with subsequent cycles of therapy • First CD19 - targeted agent to test durability benefit of repeat dosing enabled by Allo - Evasion TM edits CNTY - 101: differentiated next - gen CD19 targeted product CNTY - 101 Allo - Evasion TM edits HLA - I Knockout IL - 15 HLA - II Knockout CD19 CAR HLA - E Safety Switch

 

 

17 CNTY - 101 shows strong pre - clinical anti - tumor activity In Vitro Serial killing assay Robust activity against lymphoma xenograft Borges, et al, ASH 202 1

 

 

18 CNTY - 101: ELiPSE - 1 (NCT05336409) Phase 1 BOIN 1 Design Initial clinical data to be presented at ASH 2023 Annual Meeting in December Clinical data providing initial proof - of - concept expected in 2024 1 BOIN: Bayesian Optimal Interval 2 Standard lymphodepletion regimen: fludarabine (30 mg/m2/d) and cyclophosphamide IV (300 mg/m2/d) for 3 days 3 Subjects who are assessed as stable disease or better may receive additional cycles of CNTY - 101 Patients with CD19+ aggressive and high - risk indolent R/R B - NHL ▪ DLBCL, HGBL, MCL, PMBCL, FL3B, FL, MZL ▪ ≥ 2 prior lines of therapy ▪ Prior CD19 - targeted cell therapy allowed Part 1 - Schedule A: single dose escalation Schedule B: 1 dose per week x 3 weeks Part 2 - Dose expansion Initial Dose Additional Cycles 3 First Additional Cycle: lymphodepletion at investigator discretion No lymphodepletion for following cycles Schedule A Dose level 1: 100 x 10 6 Dose level 2: 300 x 10 6 Dose level 3: 1000 x 10 6 LYMPHO - DEPLETION 2 IL - 2 x 22 days Schedule B Dose level 2: 300 x 10 6 x3 Dose level 3: 1000 x 10 6 x3 28 - DAY DLT PERIOD RESPONSE ASSESSMENT Patient enrollment CNTY - 101 DAY 1 101 DAY 1 DAY 8 101 101 DAY 15 101 DAY 1 101 DAY 1 DAY 8 101 101 DAY 15 IL - 2 x 8 days IL - 2 x 8 days IL - 2 x 22 days

 

 

19 Initial ELiPSE - 1 data support the potential for a multi - dosing strategy for CAR iNK enabled by Allo - Evasion ۲ 65 th Annual Meeting 2023 Title: Multiple Doses of CNTY - 101, an iPSC - Derived Allogeneic CD19 Targeting CAR - NK Product, are Safe and Result in Tumor Microenvironment Changes Associated with Response: A Case Study Abstract: 1654 Session Name : 622. Lymphomas: Translational – Non - Genetic: Poster I Date : Saturday, December 9, 2023 Session Time : 5:30 PM - 7:30 PM PT Summary of Case Study Featured in ASH Abstract* • Patient with high risk relapsed/refractory follicular lymphoma • Completed four 28 - day cycles of CNTY - 101 at the 100 million cell dose (Dose Level 1 ), first two administered following lymphodepletion, while the most recent two were administered without lymphodepletion • All doses of CNTY - 101 with and without IL - 2 or LDC were well tolerated and demonstrated clinical benefit as defined as stable disease or better per Lugano 2014 criteria • Responses were associated with tumor shrinkage and an ongoing CR of a duration of 5 months since the first CNTY - 101 infusion • PK showed that CNTY - 101 cells were detected after each infusion with comparable kinetics , with a limited duration in circulation • No measurable CDC - inducing functional ADA detected in any samples by data cutoff (including the first three cycles) • T reatment was associated with changes in tumor microenvironment within 8 days post - infusion, augmentation of adaptive T cell responses, and tumor shrinkage *Data featured in abstract as of a July 10, 2023 cutoff date Additional data from Dose Level 1 patients, as well as preliminary data from Dose Level 2, to be featured at ASH Annual Meeting in December

 

 

20 ELiPSE - 1 translational approach MRD= minimum residual disease; CDC=complement - dependent cytotoxicity; ADCC= antibody - dependent cellular cytotoxicity; CAR=chimer ic antigen receptor; cf - DNA=cell free deoxyribonucleic acid Identify optimal dosing regimen Cellular Pharmacokinetics (PK) Assess impact of Allo - Evasion TM PK after redosing Humoral Cellular Functional anti - drug antibodies • CAR Neutralization • ADCC Competence • CDC Competence Evaluate mechanism of action PK in blood Persistence in the body Pharmacodynamics B cell kinetics MRD Adaptive immunity engagement iNK cf - DNA Key Methods Readouts iNK cells Immunogenicity

 

 

Discovery Programs

 

 

22 CNTY - 102: leveraging the γδ iT platform designed to deliver best - in - class potential HLA - II KO Illustrative construct γδ TCR/CD3 IL - 15/IL15RA HLA - E HLA - G HLA - I KO CD19/CD22 loop CAR Designed to address factors that limit durability of cell therapy in B - cell malignancies • γδ iT cells demonstrate high proliferation, persistence, trafficking leading to potentially sustained anti - tumor activity • Dual targeting designed to counter antigen escape relapse - a major limiting factor for durability of CD19 CAR T therapies • Armed with Allo - Evasion TM edits to enable repeat dosing to potentially deliver durable responses CNTY - 102 Allo - Evasion TM

 

 

23 Vision for winning in solid tumors with γδ iT platform Trafficking and infiltration γδ iT cells - tissue homing TME / immunosuppressive environment Requirement for chemotherapy conditioning Tumor heterogeneity Novel conditioning regimens; g enetic engineering Challenges Century’s Solution Future engineering strategies Engage endogenous immunity; m ulti tumor targeting pathways CAR CD16 TCR Cytokine support Allo - Evasion TM Enhanced fitness Tracer TBD

 

 

24 iPSC - derived γδ T cells effective at tumor control as monotherapy and in combination with antibody Millar, et al, SITC 2022 γδ - EGFR - CAR - T cells demonstrate significant CAR killing of ovarian spheroids γδ CAR - T demonstrate additive efficacy in combination with trastuzumab Treatment % TGI Significance trastuzumab 0 P=0.9980 γδ - CAR - T 18 P=0.7073 γδ - CAR - T + trastuzumab 42 P=0.0358 TGI = Tumor Growth Inhibition

 

 

25 CNTY - 107: first in class Nectin - 4 targeted γδ iT cell therapy Leveraging the power of the γδ iT cell platform for solid tumors Nectin - 4 has been validated by ADC approaches • Opportunity to address multiple Nectin - 4 positive solid tumors • Potential indications include bladder, breast, pancreatic, non - small cell lung cancer, esophageal/gastric, head and neck, and/or ovarian cancers 1 GD iT allogeneic therapies provide potential to improve upon ADC toxicity profile and efficacy • Intrinsic homing of GD iT cells to tissues and solid malignancies • Multi - tumor killing modalities to tackle heterogeneity Tumor cell killing Allo - Evasion TM Cell Fitness CNTY - 107 Illustrative construct Nectin - 4 CAR CD16 Tracer TCR Cytokine support 1. Cancer Res . 2016 May 15;76(10):3003 - 13

 

 

26 Investment thesis Next generation platforms for iNK and gamma delta iT candidates Foundational investments in iPSC technology, genetic editing, and manufacturing Experienced team in R&D, immuno - oncology, manufacturing and commercialization Exemplified by execution of ongoing first - in - human Phase 1 ELiPSE - 1 trial Well capitalized with cash runway into 2026 $284.3M in cash, cash equivalents and investments at the end of 3Q23; operational efficiencies designed to enable delivery on key milestones, clinical data

 

 

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 2026, Ended 3Q23 with cash, cash equivalents, and investments of $284.3M ~ 165 Employees including experienced leaders and entrepreneurs Emerging pipeline of candidates Product engine anticipated to deliver additional candidates and INDs in the coming years BMS Discovery Collaboration Initial focus on AML (CNTY - 104) and Multiple Myeloma (CNTY - 106)

 

 

Thank you.

 

v3.23.3
Cover
Nov. 09, 2023
Cover [Abstract]  
Document Type 8-K
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Document Period End Date Nov. 09, 2023
Entity File Number 001-40498
Entity Registrant Name Century Therapeutics, Inc.
Entity Central Index Key 0001850119
Entity Tax Identification Number 84-2040295
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 25 North 38th Street,
Entity Address, Address Line Two 11th Floor
Entity Address, City or Town Philadelphia
Entity Address, State or Province PA
Entity Address, Postal Zip Code 19104
City Area Code 267
Local Phone Number 817-5790
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Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.0001 per share
Trading Symbol IPSC
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Elected Not To Use the Extended Transition Period false

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