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Item 2.02 | Results of Operations and Financial Condition |
On August 9, 2023, Century Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 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 August 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 to be 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 August 9, 2023 | |
99.2 | Investor Presentation of Century Therapeutics, Inc., dated August 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: August 9, 2022
Exhibit 99.1
Century Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Updates
– Company remains on track to report initial data from Schedule A of the ongoing Phase 1 ELiPSE-1 trial of CNTY-101 in relapsed/refractory CD19 positive B-cell lymphomas by year end –
– Ended second quarter 2023 with cash, cash equivalents, and investments of $301.0 million; Cash runway expected into 2026 –
PHILADELPHIA, August 9, 2023 -- Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative clinical-stage biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, today reported financial results and business highlights for the second quarter ended June 30, 2023.
“Here at Century we have continued to focus on the further advancement of our pipeline, specifically our ELiPSE-1 Phase 1 trial evaluating CNTY-101 in relapsed or refractory CD19 positive B-cell lymphomas, for which we expect to report initial data from Schedule A by year end,” said Greg Russotti, Ph.D., Interim Chief Executive Officer, Century Therapeutics. “We remain confident in our differentiated scientific approach and are looking forward to spending the second half of this year working towards solidifying our position as an innovative leader in the cell therapy space.”
Business Highlights & Upcoming Milestones
● | The first-in-human Phase 1 ELiPSE-1 trial evaluating CNTY-101 in relapsed or refractory CD19 positive B-cell lymphomas is ongoing. The Company remains on track to report preliminary data from Schedule A of the trial, including pharmacokinetics, pharmacodynamics, and safety, by year end. |
● | At the American Society for Clinical Oncology (ASCO) Annual Meeting in June 2023, the Company presented a Trials in Progress poster related to its Phase 1 ELiPSE-1 trial. A copy of the poster, titled, “The ELiPSE-1 Study: A Phase 1 Multicenter Open-Label Study of CNTY-101 in Subjects with Relapsed or Refractory CD19-Positive B Cell Malignancies”, is available on the Posters section of Century’s website at https://www.centurytx.com/science/. |
Second Quarter 2023 Financial Results
● | Cash Position: Cash, cash equivalents, and marketable securities were $301.0 million as of June 30, 2023, as compared to $367.4 million as of December 31, 2022. Net cash used in operations was $48.5 million for the six months ended June 30, 2023, compared to net cash provided by operations of $61.2 million for the six months ended June 30, 2022 (which includes deferred revenue from the Bristol Myers Squibb (BMS) collaboration of $120.7 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 June 30, 2023, compared to $1.4 million for the same period in 2022. |
● | Research and Development (R&D) expenses: R&D expenses were $22.7 million for the three months ended June 30, 2023, compared to $24.5 million for the same period in 2022. The decrease in R&D expenses was primarily due to the reduction in force in January of 2023. |
● | General and Administrative (G&A) expenses: G&A expenses were $8.2 million for the three months ended June 30, 2023, compared to $8.3 million for the same period in 2022. The decrease in G&A expenses was primarily due to a reduction in headcount. |
● | Impairment of long lived assets: A one-time impairment charge of $4.2 million was recorded in connection with the strategic decision to consolidate two of the Company’s existing leased facilities in Philadelphia. |
● | Net loss: Net loss was $33.3 million for the three months ended June 30, 2023, compared to $31.0 million for the three months ended June 30, 2022. |
Financial Guidance
● | The Company expects full year generally accepted accounting principles (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 estimates 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 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. 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 cancer care. 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 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)
June 30, | December 31, | |||||||
2023 | 2022 | |||||||
Assets | ||||||||
Current Assets: | ||||||||
Cash and cash equivalents | $ | 64,439 | $ | 84,265 | ||||
Short-term investments | 91,958 | 231,233 | ||||||
Prepaid expenses and other current assets | 4,883 | 4,223 | ||||||
Total current assets | 161,280 | 319,721 | ||||||
Property and equipment, net | 83,771 | 82,785 | ||||||
Operating lease right-of-use assets, net | 24,993 | 28,945 | ||||||
Long-term investments | 144,581 | 51,854 | ||||||
Other long-term assets | 2,534 | 3,239 | ||||||
Total assets | $ | 417,159 | $ | 486,544 | ||||
Liabilities, convertible preferred stock, and stockholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 3,625 | $ | 5,454 | ||||
Accrued expenses and other liabilities | 8,600 | 10,707 | ||||||
Long-term debt, current | - | 6,502 | ||||||
Deferred revenue, current | 6,936 | 7,154 | ||||||
Total current liabilities | 19,161 | 29,817 | ||||||
Operating lease liability, noncurrent | 40,833 | 38,698 | ||||||
Long-term debt, net | - | 3,739 | ||||||
Other long-term liabilities | 361 | 718 | ||||||
Deferred revenue | 109,233 | 110,834 | ||||||
Total liabilities | 169,588 | 183,806 | ||||||
Stockholders' equity | ||||||||
Common stock | 6 | 6 | ||||||
Additional paid-in capital | 832,425 | 824,292 | ||||||
Accumulated deficit | (583,653 | ) | (519,098 | ) | ||||
Accumulated other comprehensive loss | (1,207 | ) | (2,462 | ) | ||||
Total stockholders' equity | 247,571 | 302,738 | ||||||
Total liabilities and stockholders' equity | $ | 417,159 | $ | 486,544 |
Century Therapeutics, Inc
Condensed consolidated statements of operations
(unaudited, in thousands, except share and per share amounts)
Three months Ended | Six months Ended | |||||||||||||||
June 30, | June 30, | June 30, | June 30, | |||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Collaboration Revenue | $ | 99 | $ | 1,396 | $ | 1,819 | $ | 2,454 | ||||||||
Operating Expenses | ||||||||||||||||
Research and development | $ | 22,727 | $ | 24,494 | $ | 47,626 | $ | 45,690 | ||||||||
General and administrative | 8,229 | 8,253 | 17,131 | 15,551 | ||||||||||||
In-process research and development | - | - | - | 10,000 | ||||||||||||
Impairment on long-lived assets | 4,220 | - | 4,220 | - | ||||||||||||
Total operating expenses | $ | 35,176 | $ | 32,747 | $ | 68,977 | $ | 71,241 | ||||||||
Loss from operations | (35,077 | ) | (31,351 | ) | (67,158 | ) | (68,787 | ) | ||||||||
Interest expense | (136 | ) | (330 | ) | (540 | ) | (644 | ) | ||||||||
Interest income | 3,058 | 706 | 5,681 | 960 | ||||||||||||
Other income, net | (186 | ) | 5 | (380 | ) | 4 | ||||||||||
Loss before provision for income taxes | $ | (32,341 | ) | $ | (30,970 | ) | $ | (62,397 | ) | $ | (68,467 | ) | ||||
Provision for income taxes | (950 | ) | (18 | ) | (2,158 | ) | (34 | ) | ||||||||
Net Loss | $ | (33,291 | ) | $ | (30,988 | ) | $ | (64,555 | ) | $ | (68,501 | ) | ||||
Unrealized loss on investments | 59 | (780 | ) | 1,255 | (2,766 | ) | ||||||||||
Foreign currency translation adjustment | 9 | (12 | ) | - | (18 | ) | ||||||||||
Comprehensive loss | (33,223 | ) | (31,780 | ) | (63,300 | ) | (71,285 | ) | ||||||||
Net loss per common share - Basic and Diluted | (0.56 | ) | (0.54 | ) | (1.10 | ) | (1.19 | ) | ||||||||
Weighted average common shares outstanding | 59,251,363 | 57,685,006 | 58,904,726 | 57,370,022 |
Corporate Overview Aug 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 FDA clearance of Century’s first IND for CNTY-101 & trial execution Well capitalized with cash runway into 2026 $301.0M in cash, cash equivalents and investments at the end of 2Q23; 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 ft2 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 |
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 Precise 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-EvasionTM edits + repeat dosing = potential greater durability Next-wave of allogeneic cell therapies must solve for challenge of rejection With Allo-EvasionTM engineering Without Allo-EvasionTM engineering |
9 Allo-EvasionTM 1.0 designed to overcome 3 major pathways of host vs graft rejection 1. Deletion of β2M, 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 b2M 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-EvasionTM 3.0 Provides Additional Protection Against NK Cell Killing 1. Deletion of β2M, 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 b2M 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 0.125 0.25 0.5 1 2 4 8 16 32 0 20 40 60 80 100 Donor RC01 Ratio (E:T) % Killing 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 No edit HLA-G HLA-E HLA-E/G 0.0 0.2 0.4 0.6 0.8 1.0 Relative cytolysis |
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 Solid Tumors Hematologic Tumors |
14 Promise of allogeneic cell therapies in lymphoma Large unmet need remains despite progress with autologous cell therapies • ~25% of eligible patients receive CAR-T therapy1 • ~35% of patients achieve long-term remission even in earlier lines of therapy1 Off-the-shelf modalities approaching bar set by autologous but falling short on durability • Rejection limits potential of durable responses for first wave of allogeneic cell products • Bispecifics lack curative potential of cell therapy Goal to deliver more durable response rates vs autologous X • Century candidates designed to realize benefit of repeat dosing enabled by Allo-EvasionTM • Shift from “one and done” to finite repeat dosing to increase pharmacological pressure 1. Targeted Oncology, Many Challenges, Opportunities for CAR T-Cell Therapies in Lymphoma, Sept 2022 |
15 Delivering on our vision to change the cell therapy treatment paradigm • Goal to improve durability, tolerability and ease of outpatient administration • Potential to eliminate need for lymphodepletion with subsequent cycles of therapy • First CD19-targeted agent to test durability benefit of repeat dosing enabled by Allo-EvasionTM edits CNTY-101: Differentiated next-gen CD19 targeted product CNTY-101 Allo-EvasionTM edits HLA-I Knockout IL-15 HLA-II Knockout CD19 CAR HLA-E Safety Switch |
16 CNTY-101 shows strong pre-clinical anti-tumor activity In Vitro Serial killing assay Robust activity against lymphoma xenograft Borges, et al, ASH 2021 |
17 ELiPSE-1: Ongoing first-in-Human Study CNTY-101 in patients with patients with relapsed/refractory CD19+ B-cell lymphomas Study to assess: Impact of Allo-EvasionTM on iNK cell persistence and PK after multiple dosing (Schedule B) Multiple dose regimen with up to 6 doses with single lymphodepletion conditioning Potential to increase durability of responses with Allo-EvasionTM enabled repeat dosing regimen Day 1 LD Day 50 Subsequent dose(s) without additional LD* ≥1bn cells/dose * Subject to FDA approval Schedule A: Single ascending dose study (3+3 escalation design) DL1 DL2 DL3 100M 300M 1Bn Schedule B: Accessing multiple doses per cycle + IL-2 2 nd cycle of single dose allowed for patients who demonstrate benefit • Initial clinical data including PK, PD and safety data from Schedule A expected by end of 2023 • Clinical data providing initial proof-of-concept expected in 2024 |
t 8 , 2 0 2 3 1 8 Lymphodepletion, Century product infusion CNTY-101 CRP IL-15 % VAF Blood Serum/ Plasma Tumor Biopsy Mechanism of Action/ Resistance Safety & Other Efficacy Correlates Pharmacokinetics: Expansion & Persistence Phenotype & function Homeostatic cytokines, IL-2 Minimum residual disease (ctDNA) iNK tumor Trafficking Tumor Antigen expression Tumor immune microenvironment Tumor Biology Tumor burden and other baseline biomarkers PD biomarkers/ B cell aplasia Cellular Immunogenicity Humoral Immunogenicity Cytokines: CRS, neurotoxicity ELiPSE-1 translational endpoints |
19 CNTY-102: Leveraging the γδ iT platform designed to deliver best-in-class potential HLA-II KO Illustrative construct γδTCR/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-EvasionTM edits to enable repeat dosing to potentially deliver durable responses CNTY-102 Allo-EvasionTM |
20 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 • Genetic engineering Challenges Century’s Solution Future engineering strategies • Engage endogenous immunity • Multi tumor targeting pathways CAR CD16 TCR Cytokine support Allo-Evasion TM Enhanced fitness Tracer TBD |
21 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 γδCAR-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 |
22 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 cancers1 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-EvasionTM Cell Fitness CNTY-107 Illustrative construct Nectin-4 CAR CD16 Tracer TCR Cytokine support 1. Cancer Res . 2016 May 15;76(10):3003-13 |
23 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 FDA clearance of Century’s first IND for CNTY-101 & trial execution Well capitalized with cash runway into 2026 $301.0M in cash, cash equivalents and investments at the end of 2Q23; 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 2Q23 with cash, cash equivalents, and investments of $301M ~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. |