Form 8-K - Current report

 

 

 

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 5, 2024

 

 

 

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: [phone]

 

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 5, 2024, Century Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2024. 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 8.01

Regulation FD Disclosure

 

On November 5, 2024, 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.

 

Item 9.01

Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit No.		Document
99.1		Press Release of Century Therapeutics, Inc., dated November 5, 2024
99.2		Investor Presentation of Century Therapeutics, Inc., dated November 5, 2024
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/ Brent Pfeiffenberger, Pharm.D.
	Name:	Brent Pfeiffenberger, Pharm.D.
	Title:	President and Chief Executive Officer

 

Date: November 5, 2024

 

 

 

 

Exhibit 99.1

 

 

 

Century Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Updates

 

– Expansion of Phase 1 CALiPSO-1 trial of CNTY-101 in autoimmune disease to include diffuse cutaneous systemic sclerosis and idiopathic inflammatory myopathy –

 

– Overall response rate (ORR) of 83% observed at CNTY-101 Dose Level 3B alongside a favorable safety profile in patients with r/r B-cell lymphomas in Phase 1 ELiPSE-1 study –

 

– CNTY-101 shows persistence upon repeated cell dosing at Dose Level 3B, consistent with the anticipated protective activity of Century’s proprietary Allo-Evasion™ technology –

 

– Ended third quarter 2024 with cash, cash equivalents, and investments of $244.7 million; organizational efficiencies extend expected cash runway into second half of 2026 –

 

PHILADELPHIA, November 5, 2024 -- Century Therapeutics, Inc. (“Century”, NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune disease, today reported financial results and business highlights for the third quarter ended September 30, 2024.

 

“Broadening our strategic focus in autoimmune indications to include idiopathic inflammatory myopathy and diffuse cutaneous systemic sclerosis will give us greater insight into the potential of CNTY-101 in an underserved therapeutic category that we believe is uniquely suited to allogeneic iNK cell therapies. Our confidence in the application of CNTY-101 in autoimmune diseases continues to be reinforced by the Phase 1 ELiPSE-1 trial in patients with r/r B-cell lymphomas where updated interim data shows increased overall response rates at higher doses and observations of deepening responses with additional cycles, alongside a continued favorable safety profile,” said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics. “The advancement of our pre-clinical pipeline across multiple cell types is similarly promising, as highlighted by what we believe to be the industry-first presentation of iPSC-derived CD4+ and CD8+ CAR T cells that demonstrate αβ-like T cell function at the upcoming American Society of Hematology Annual Meeting. Building on this progress, we are conducting a strategic review of Century’s pre-clinical pipeline and expect to announce the outcome in the first quarter of 2025. We have recently refined our organizational structure to enhance ongoing efficiencies and program alignment. On behalf of everyone here at Century, I’d like to thank departing colleagues for their important contributions to building the company’s programs and technology. Supported by extended cash runway from these changes, we remain focused on execution in the period ahead and look forward to delivering our next set of potential catalysts.”

 

Research & Development Highlights

 

·

Consistent with Century’s commitment to expand investigation of autoimmune disease indications during the second half of 2024, the company recently amended the Phase 1 CALiPSO-1 trial of CNTY-101 (NCT06255028) and Investigational New Drug (IND) application to include evaluation of idiopathic inflammatory myopathy (IIM) and diffuse cutaneous systemic sclerosis (dcSSc). This builds upon earlier alignment with the U.S. Food and Drug Administration to expand clinical development to lupus nephritis (LN) in addition to systemic lupus erythematosus (SLE). With the implementation of this amendment, CALiPSO-1 consists of a basket protocol study design, with four arms designed to evaluate the safety and preliminary efficacy of CNTY-101. The study will enroll participants ≥17 years old with refractory B-cell-mediated autoimmune diseases following an inadequate response to at least two lines of prior standard of care immunosuppressive therapies, now including those with moderate to severe IIM and dcSSc with treatment-resistant and active disease alongside those with moderate to severe SLE with or without LN. Century has activated multiple clinical sites in the United States, and expects to activate additional sites in the coming months, with ability to enroll patients across indications. To further facilitate enrollment, the company plans to expand trial sites to select European countries. Century will provide updated timing on initial clinical data from CALiPSO-1 once a clear cadence of patient enrollment has been established across indications.

 

 

 

 

 

 

·

Updated interim clinical data from Century’s ongoing Phase 1 ELiPSE-1 study evaluating CNTY-101 (NCT05336409) in relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) has shown increased overall response rates at higher doses and observations of deepening responses with additional cycles alongside a favorable safety profile, building on encouraging interim data previously presented at the 2024 American Society of Clinical Oncology Annual Meeting. As of the data snapshot October 15, 2024, eight additional participants have been treated with CNTY-101 for a total of 20 participants evaluable for safety and 19 for preliminary efficacy. Treatment with CNTY-101 continued to be safe and generally well tolerated with no dose-limiting toxicities reported, no additional cases of immune effector cell-associated neurotoxicity syndrome (ICANS), and no Grade 3 or higher cytokine release syndrome (CRS). Consistent with the manageable safety profile observed to date, a majority of participants received CNTY-101 infusions in an outpatient setting. Dose level DL3B (1 billion cells in each of three weekly doses per cycle), which represents the largest single trial cohort (n=6), has shown an overall response rate (ORR) of 83% and a complete response rate (CRR) of 33%, with all participants receiving additional cycles of treatment.

 

A dose-dependent increase in CNTY-101 exposure was observed as evaluated by a novel pharmacokinetics cell-free DNA (cfDNA) method for detecting total body presence of CNTY-101. Preliminary cfDNA data from Schedule B (three weekly CNTY-101 infusions per cycle) showed that in cycles starting with lymphodepletion, a similar level of exposure was observed between the first and third infusion when the patients’ endogenous T and NK cells had recovered. This supports persistence upon repeated cell dosing, consistent with the anticipated protective activity of Century’s proprietary Allo-Evasion™ technology.

 

Efficient B-cell depletion was observed in all participants treated with CNTY-101 who had measurable circulating B cells at baseline. Evaluable re-emergent B cells (N=4 participants) were enriched for naive subtypes with minimal class-switched memory subsets detected. This profile in re-emergent B cells has been associated with SLE responses after CD19 cell therapy treatment, which we believe further supports application of CNTY-101 in the CALiPSO-1 study. Based on favorable safety and encouraging early efficacy data at DL3B, Century is proceeding with DL4B (3 billion cells in each of three weekly doses per cycle), and recently treated the first participant at this dose. The company expects to provide updated clinical data by mid-2025.

 

 

 

 

 

 

Further details pertaining to the ELiPSE-1 data update can be found in Century’s corporate presentation housed on the investor relations section of the website.

 

·

Century separately announced  the acceptance of five poster presentations at the upcoming 66th American Society of Hematology Annual Meeting to be held in San Diego, CA from December 7-10, 2024. The presentations include demonstration of pre-clinical function comparable to autologous T cells by allogeneic iPSC-derived CD4+ and CD8+ CAR T cells, alongside additional innovations that highlight the engineerability of the iPSC-derived immune effector cells, a core benefit of the company’s platform. These include data from advanced CAR endo-domains that improved cytotoxicity and persistence, enhanced Allo-Evasion™ via a novel CD300a TASR that demonstrated universal protection from NK cells, and differentiation stage specific promoters that allow for selective control of gene expression.

 

Business Highlights

 

·

Following the integration of Clade Therapeutics, Century is conducting a strategic review of the pre-clinical pipeline to leverage the unique capabilities and technologies at Century towards high-value and differentiated programs. The company expects to conclude and communicate the results of this review in the first quarter of 2025. As part of this review, in October, Century implemented changes to the organization structure including elimination of overlapping technical and research capabilities to enhance ongoing efficiencies and alignment with the company’s key programs. With these changes, Century has extended expected cash runway into the second half of 2026.

 

·

In September 2024, Century announced the appointments of Morgan Conn, Ph.D., as Chief Financial Officer and Chad Cowan, Ph.D., as Chief Scientific Officer. The company also announced the transition of Hy Levitsky, M.D., President of Research and Development, from operational duties to serve as an advisor to Century.

 

Third Quarter 2024 Financial Results

 

·

Cash Position: Cash, cash equivalents, and marketable securities were $244.7 million as of September 30, 2024, as compared to $261.8 million as of December 31, 2023. Net cash used in operations was $85.9 million for the nine months ended September 30, 2024, compared to net cash used in operations of $62.1 million for the nine months ended September 30, 2023.

 

·

Collaboration Revenue: Collaboration revenue generated through the company’s collaboration, option, and license agreement with Bristol-Myers Squibb was $0.8 million for the three months ended September 30, 2024, compared to $0.1 million for the same period in 2023.

 

·

Research and Development (R&D) expenses: R&D expenses were $27.2 million for the three months ended September 30, 2024, compared to $22.8 million for the same period in 2023. The increase in R&D expenses was primarily due to progression of the ELiPSE-1 trial and start-up costs of the CALiPSO-1 trial, increased manufacturing activity for CNTY-101, and the acquisition of Clade Therapeutics.

 

 

 

 

 

 

·

General and Administrative (G&A) expenses: G&A expenses were $8.4 million for the three months ended September 30, 2024, compared to $9.0 million for the same period in 2023.

 

·

Net loss: Net loss was $31.2 million for the three months ended September 30, 2024, compared to $32.7 million for the three months ended September 30, 2023.

 

Financial Guidance

 

·

The company expects full year generally accepted accounting principles (GAAP) operating expenses to be between $150 million and $160 million.

 

·

The company estimates its cash, cash equivalents, and investments will support operations into the second half of 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 diseases that we believe will allow us to overcome the limitations of first-generation cell therapies. Our genetically engineered, iPSC-derived cell product candidates are designed to specifically target hematologic and solid tumor cancers, with a broadening application to 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 cancer and autoimmune disease care. For more information on Century Therapeutics, please visit www.centurytx.com.

 

About Idiopathic Inflammatory Myopathy

 

Idiopathic inflammatory myopathies (IIM) include a heterogenous group of rare disorders including dermatomyositis and polymyositis in which the immune system attacks muscle and frequently the lungs, skin, joints, and gastrointestinal tract. IIM can cause weakness, pain, and lung failure which can lead to chronic disability and potentially mortality. With a prevalence of at least 60,000 people in the US, significant unmet need in IIM stems from the limited efficacy of current therapies, as corticosteroids and immunosuppressants often fail to halt disease progression. Additionally, these treatments carry significant side effects, including increased infection risk and long-term complications. A lack of targeted therapies and reliable biomarkers for early diagnosis complicates disease management and underscores the urgent need for better treatment options and personalized care approaches.

 

 

 

 

 

 

About Systemic Sclerosis  

 

Systemic sclerosis (SSc), a type of scleroderma, is a chronic autoimmune disease characterized by inflammation and hardening with tightening of the skin and internal organs such as the lungs, heart, and gut, leading to life-threatening complications. Over half of people with SSc develop lung fibrosis, a leading cause of death. SSc, which affects at least 80,000 people in the US, typically appears between the ages of 30 and 50. A third of this patient population has diffuse cutaneous systemic sclerosis, the most severe and rapidly progressing disease subtype. There is no cure for SSc, and current therapies focus on managing symptoms and slowing disease progression. Medications like immunosuppressants, vasodilators, and antifibrotic agents may help, but often come with significant side effects. Furthermore, treatment response varies between people, and organ damage may be irreversible by the time of diagnosis, making early detection and intervention crucial. 

 

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 and the initial safety and efficacy profiles of CNTY-101 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 and our ability to progress CNTY-101 through our CALiPSO and ELiPSE Phase 1 clinical trials; our ability to meet development milestones on anticipated timelines; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials, which may not be predictive of final results or the results of later-stage clinical trials; our ability to obtain FDA clearance of our future IND submissions and commence and complete 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 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:

 

Investor Relations & Media Contacts

 

Century Therapeutics 

Katja Buhrer 

SVP, Head of Corporate Affairs and Strategy 

[e-mail] 

917-969-3438

 

Argot Partners 

Julie Seidel/Noor Pahlavi 

[e-mail] 

212-600-1902

 

 

 

 

 

 

Century Therapeutics, Inc

Condensed Balance Sheets

(unaudited, in thousands)

 

		September 30,				December 31,
Assets		2024				2023
Current Assets:		$				$
Cash and cash equivalents			52,593				47,324
Short-term investments			145,519				125,414
Prepaid expenses and other current assets			7,897				4,256
Total current assets			206,009				176,994
Property and equipment, net			65,284				71,705
Operating lease right-of-use assets, net			28,828				20,376
Long-term investments			46,565				89,096
Goodwill			4,727				-
Intangible assets			33,800				-
Other long-term assets			3,404				2,520
Total assets		$	388,617			$	360,691
Liabilities, convertible preferred stock, and stockholders' equity
Current liabilities:
Accounts payable		$	2,598			$	2,741
Accrued expenses and other liabilities			13,653				10,733
Deferred revenue, current			3,569				4,372
Total current liabilities			19,820				17,846
Operating lease liability, noncurrent			50,837				46,658
Other long-term liabilities			20				56
Deferred revenue			109,768				111,381
Contingent consideration liability			8,983				-
Deferred tax liability			3,503				-
Total liabilities			192,931				175,941
Stockholders' equity
Common stock			9				6
Additional paid-in capital			941,185				840,407
Accumulated deficit			(746,266	)			(655,771	)
Accumulated other comprehensive loss			758				108
Total stockholders' equity			195,686				184,750
Total liabilities and stockholders' equity		$	388,617			$	360,691

 

 

 

 

 

 

Century Therapeutics, Inc

Condensed consolidated statements of operations

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

 

		Three Months Ended				Three Months Ended				Nine Months Ended				Nine Months Ended
		September 30, 2024				September 30, 2023				September 30, 2024				September 30, 2023
Collaboration Revenue		$	791			$	148			$	2,416			$	1,967
Operating Expenses
Research and development			27,228				22,788				77,869				70,414
General and administrative			8,352				8,986				25,400				26,117
In-process research and development			-				4,000				-				4,000
Impairment on long-lived assets			-				-				-				4,220
Total operating expenses			35,580				35,774				103,269				104,751
Loss from operations			(34,789	)			(35,626	)			(100,853	)			(102,784	)
Interest expense			-				-				-				(540	)
Interest income			3,305				3,486				10,126				9,167
Other income, net			250				12				248				(368	)
Loss before provision for income taxes			(31,234	)			(32,128	)			(90,479	)			(94,525	)
Benefit (provision) for income taxes			8				(592	)			(14	)			(2,750	)
Net Loss		$	(31,226	)		$	(32,720	)		$	(90,493	)		$	(97,275	)
Unrealized gain (loss) on investments			1,075				(95	)			622				1,157
Foreign currency translation adjustment gain (loss)			(8	)			(2	)			28				(1	)
Comprehensive loss		$	(30,159	)		$	(32,817	)		$	(89,843	)		$	(96,119	)
Net loss per common share - Basic and Diluted			(0.37	)			(0.55	)			(1.18	)			(1.65	)
Weighted average common shares outstanding			84,704,352				59,448,229				76,394,266				59,087,374

 

 

 

 

Exhibit 99.2

 

November 2024 Corporate overview

 

 

2 Forward - looking statements This presentation 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 presentation, 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 and the initial safety and efficacy profiles of CNTY - 101 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 dependence on the success of our lead product candidate, CNTY - 101; and our ability to progress CNTY - 101 through our CALiPSO and ELiPSE Phase 1 clinical trials; our ability to meet development milestones on anticipated timelines; uncertainties inherent in the results of preliminary data, pre - clinical studies and earlier - stage clinical trials, which may not be predictive of final results or the results of later - stage clinical trials; ; our ability to obtain FDA clearance of our future IND submissions and commence and complete 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 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. 1

 

 

3 Century Therapeutics: Building an industry - leading, next - generation allogeneic iPSC - derived cell therapy platform Foundational investments in iPSC technology, genetic editing, protein engineering, and manufacturing Limitless Potential… Progressing differentiated clinical programs based on Allo - Evasion technology in oncology and autoimmune diseases Precision Design… Well - capitalized into 2H 2026 to enable delivery on key milestones and clinical data Enduring Impact… 1

 

 

Overview of foundational platform technologies

 

 

5 Century’s singular focus: To deliver best - in - class iPSC - derived cell therapies Century platform enables the incorporation of critical features we b elieve can only be realized via iPSC - derived cell therapies Production from a master cell bank , compared to donor - derived or autologous cell products, enables • Larger batch sizes • Reduced cost of goods • Batch - to - batch consistency with a single donor source Infinite replicative capacity of iPSCs • Potential for unlimited genomic engineering via CRISPR editing • Leverage multiple advances in synthetic biology into a single product Single - cell cloning of engineered iPSC • Enables full characterization of clone forming master cell bank • Deep understanding of cell function and safety • F unctional reproducibility of the final drug product Differentiation conditions for multiple immune effector cells • NK cells • CD4+ T cells • CD8+ T cells • T cells Large cell harvests from c ell expansion across differentiation stages • Decreased risk of cell exhaustion • Robust drug inventory, potentially infinitely replenishable • Path to reduced cost of goods 1

 

 

6 Century’s next - generation allogeneic iPSC technology platform: Versatility and unprecedented control Rapid Integration of major advances in product functionality and manufacturability iPSC iT cell iNK cell SINGLE CELL CLONING POST GENE EDITING AND CHARACTERIZATION DIFFERENTIATION Consistency Yield Fitness: No exhaustion Allo - Evasion TM Homeostasis/ persistence Modulation of TME Safety switch Integration of advances in synthetic biology Product design Manufacturing Engineered iPSC MCB 1

 

 

7 Precision CRISPR MAD7 mediated sequential gene editing of iPSCs generates uniform product candidates Multiple gene edits (KO/KI) iPSC bank Engineered iPSC Master Cell Bank (MCB) Sequential selection steps iPSC Precision Engineering CRISPR - mediated HDR (MAD 7) 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 1

 

 

8 Allo - Evasion edits + repeat dosing = potential greater durability Potential to drive durable responses with engineering to resist immune rejection Next - wave of allogeneic cell therapies must solve for challenge of rejection With Allo - Evasion engineering Without Allo - Evasion engineering Dose 1 Dose 2 Dose 3 1

 

 

9 Advancing our leadership in Allo - Evasion technology Continuous improvement in holistic immune protection designed to overcome major pathways of host vs. graft rejection Allo - Evasion 1.0 Allo - Evasion 3.0 Allo - Evasion 5.0 Core edits disarm host cells from eliminating therapy • Deletion of β 2M, a protein required to express HLA - I on the cell surface prevents recognition by CD8 T cells • Knock out of CIITA eliminates HLA - II expression to escape elimination by CD4 T cells • Knock - in of HLA - E prevents killing by NK cells Allo - Evasion 1.0 edits plus the incorporation of: • Knock - in of HLA - G improves protection against killing by NK cells • Deletion of β 2M, a protein required to express HLA - 1 on the cell surface prevents recognition by CD8 T cells • Knock out of CIITA eliminates HLA - II expression to escape elimination by CD4 T cells • Pan - NK inhibitory ligand to provide broader protection against killing by NK cells • IgG degrading protease designed to protect against humoral immunity b2M KO (HLA - I) CIITA KO (HLA - II) CD8 + T Cell CD4 + T Cell Pan NK Inhibitory ligand F c NK cell 1 2 9 1

 

 

10 Foundational investments in iPSC manufacturing Developing fit - for - purpose products Established in - house manufacturing • Increased process and product consistency • Scalable platforms and optimized processes to maximize yield, reduce COGs, and meet demand • Increased cell fitness, as cells do not undergo excessive expansion cycles which often result in cell exhaustion • Homogeneity of the manufacturing process produces a product candidate that can be readily characterized • Century 53,000 ft 2 GMP facility • Designed to produce multiple immune cell types • Accelerates learnings and enables faster product iteration • Two sites (FCDI GMP manufacturing, Century in - house manufacturing) provide optionality and maximizes flexibility 1

 

 

Pipeline

 

 

12 Collaborator Clinical IND - enabling Research Indications Targets iPSC Platform Product P3 P2 P1 Autoimmune diseases B cell - mediated Autoimmune diseases CD19 iNK CNTY - 101 Autoimmune diseases CD19 iNK / iT CNTY - 108 Autoimmune diseases CD19 iT CLDE - 308 Myasthenia Gravis BCMA iT CLDE - 361 Hematologic and Solid tumors B - Cell Malignancies CD19 iNK CNTY - 101 B - Cell Malignancies CD19 + CD22 iT CNTY - 102 B - Cell Malignancies CD19 iT CLDE - 308 AML Multi - specific iNK / iT CNTY - 104 MM Multi - specific iNK / iT CNTY - 106 Solid tumors Nectin - 4 iT CNTY - 107 Solid tumors Not disclosed iT Research Hematologic and Solid tumors TBD iNK / iT Research Diversified pipeline spanning cell types and targets in cancer and autoimmune diseases Autoimmune diseases CALiPSO - 1 ELiPSE - 1 Hematologic tumors Solid tumors

 

 

CNTY - 101 Clinical programs

 

 

14 CNTY - 101: Differentiated next - gen CD19 targeted product Only cell therapy with six precision gene edits currently in the clinic 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 - Evasion edits CNTY - 101 Allo - Evasion edits HLA - I Knockout IL - 15 HLA - II Knockout CD19 CAR HLA - E Safety Switch 1

 

 

15 R /R: Relapsed or Refractory, NHL: Non - Hodgkin Lymphoma, CAR - T: Chimeric Antigen Receptor T cell therapy 1 Cappell, Nature Reviews Clinical Oncology (2023) CNTY - 101 in relapsed/refractory B - cell lymphomas Aim : To deliver durable responses via repeat dosing facilitated by Allo - Evasion and extending the period of pharmacologic pressure on tumor cells Potential solution from Century’s platform: Unmet need: • Off - the - shelf product offers immediate access and consistency • Multiple doses to increase pharmacological pressure to increase durability • Host rejection addressed by Allo - Evasion edits • Autologous CD19 CAR - T is curative in ~40 % 1 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

 

 

16 1. Standard lymphodepletion regimen: fludarabine (30 mg/m/d) and cyclophosphamide IV (300 mg/m/d) for 3 days ​ 2. Subjects who are assessed as stable disease or better may receive additional cycles of CNTY - 101 ​ 3. Subjects at DL4A did not receive IL - 2 on the day of CNTY - 101 infusion but did receive IL - 2 daily for 7 days 4. For DL 4B, initial 2 cycles at DL 4B; subsequent cycle regimen depending on response or risk/benefit CNTY - 101: ELiPSE - 1 (NCT05336409) Phase 1 BOIN design Patients with CD19+ aggressive and high - risk indolent R/R B - NHL • Part 1 – Dose escalation • Schedule A: Single dose • Schedule B: 1 dose per week x 3 weeks • Part 2 – Dose expansion BOIN: Bayesian Optimal Interval, DLT: Dose Limiting Toxicity; IL - 2: Interleukin - 2 (dose: 3e6 IU; subcutaneous) • DLBCL, HGBL, MCL, PMBCL, FL3B, FL, MZL • > 2 prior lines of therapy • Prior CD19 - targeted cell therapy allowed Dose level 4: 3 billion 4

 

 

17 1 As of 15 October 2024 data snapshot date, data collection ongoing 2 HRFL: High - risk Follicular Lymphoma; DLBCL: Diffuse large B cell Lymphoma; MZL: Marginal Zone Lymphoma; MCL: Mantle Cell Lymphoma Safety evaluable N = 20 Baseline characteristics 66 (51 – 80) Median age (range, years) 16 (80) Male, n (%) 3.34 (0.5 – 18.8) Median follow up (range, months) NHL subtype, n (%) 11 (55) DLBCL 2 (10) HRFL 4 (20) MCL 3 (15) MZL 4 (2 – 6) Prior therapies, median (range) Response to Last Line of Treatment, n (%) 8 (40) Relapsed 12 (60) Refractory 9 (45) Received Prior CAR T, n (%) ELiPSE - 1 enrolled heavily pre - treated R/R B - NHL patients

 

 

18 CNTY - 101 clinical data snapshot Increased ORR at higher dose alongside a favorable safety profile As of 15 October 2024, data snapshot date, data collection ongoing, efficacy based on Lugano criteria | CR: Complete Response, ORR: Overall Response Rate, DLTs: Dose Limiting Toxicities, CRS: Cytokine Release Syndrome, ICANS: Immune Effector Cell - Associated Neurotoxicity Syndrome, CAR: Chimeric Antigen Receptor | Schedule A (1 dose in a 28 - day cycle); Schedule B (3 weekly doses in a 28 - day cycle) ; DL1: (100e6), DL2: (300e6), DL3: (1e9), D L4: (3e9); n= 19 total pts evaluable for efficacy, 58% BoR median follow up 3.34 months (range 0.5 - 18.8 months) Efficacy (DL3B, N=6) • 83% ORR; median follow up 2.9 months (range 1.2 – 5.3 months) • All subjects were eligible to receive additional cycle(s) • 4 patients received prior autologous CAR T therapy Safety & Tolerability (N=20) • No GvHD; no DLTs • CRS: Grade 1 (N=3), Grade 2 (N=3) • Hypotension (n=2) and hypoxia (n=1) lasted <24 hrs • ICANS: Grade 1 (n=1), resolved in <24hrs • Majority of subjects received at least one dose in the outpatient setting 3 1 1 1 1 1 1 1 1 3 1 1 1 2 0 1 2 3 4 5 6 7 100e6 (1A) 300e6 (2A) 1e9 (3A) 3e9 (4A) 300e6 (2B) 1e9 (3B) Schedule A (One infusion/cycle) Schedule B (Three infusions/cycle) # of subjects Best Overall Response per Lugano PD SD PR CR

 

 

19 PBMC genomic DNA Plasma cell - free DNA Increasing CNTY - 101 exposure with dose and schedule • Extended persistence in circulation at dose level 4A (1 x 1e9 cell infusion) • Persistence outside the bloodstream was detected via a cell - free ( cf ) DNA assay beyond day 15 • Multiple infusions in Schedule B drive increased exposure throughout the dosing cycle Transgene copies per ug were determined using ddPCR with primers targeting transgene and RPP30. Data shows cycles with LDC across subjects at each dose level. Error bars shown are mean “ SD. LLOQ: Lower limit of quantification. Black triangle indicates infusion. S: Screen Error bars show mean “ SD (due to log10 scale, low values are truncated at 1). Positivity values are determined to be significantly above LOB using two sample Poisson test, p < 0.05. All LDC+ cycles are shown. Black triangles indicate infusions. S: Screen, LOB: Lim it of Blank. Schedule A Schedule B Day in cycle Day in cycle Translational data available as of Oct 28, 2024; Schedule A n=11, Schedule B n=8 Schedule A Day in cycle

 

 

20 • Lymphodepleting Chemotherapy (LDC) depleted patient NK/T cell counts and drove a transient spik e of IL - 15 cytokine • By post - infusion day 8 , NK/T cell counts, IL - 15 concentration returned to screening level • Similar PK profile observed for each CNTY - 101 infusion within a cycle despite evident patient immune recovery Enabled with Allo - Evasion , CNTY - 101 infusions in dose level 3B showed similar exposure in the presence or absence of endogenous lymphocytes Translational data available as of Oct 28, 2024 Graphs show data from 3B cohort. Lines in the top panel represent mean and shaded area represents 1*SEM. Triangles mark CNTY - 101 infusions within a Schedule B cycle, grey arrow indicates LDC. Dotted blue line is a LOESS fit to medians in bottom panel. S: Screen Lymphocyte counts and PK profile Infusion LDC Model of Allo - Evasion enabled cellular kinetics

 

 

21 B - cell depletion Re - emergent B - cell profile Graphs show data from the initial cycle of all subjects who had B cell counts of 0.25 cell/ L or greater (N=10). ). Each line represents an individual subject. Data from a subject with supraphysiological levels of circulating malignant B cells was excluded. Data shows proportion of non - class switched ( IgD +, IgM+ or IgD+IgM +) or switched ( IgD - IgM - ) circulating B cells (CD19+ CD20+) in healthy donors (N=4) or within earliest evaluable re - emergent B cells in patients (N=4). Majority of the B cells exhibited a naïve profile ( IgD + CD27 - , data not shown). • Rapid and effective depletion of circulating B cells observed in the initial cycle • A reduction of class - switched phenotypes in re - emergent B cells has been associated with SLE responses to CD19 - targeted cell therapies, further supporting use of CNTY - 101 in the CALiPSO - 1 study CNTY - 101 treatment demonstrates rapid B - cell depletion and was associated with a naive non - class switched profile of re - emergent B - cells Data in r/r NHL patients supports the application of CNTY - 101 in autoimmune diseases Translational data available as of Oct 28, 2024

 

 

22 ELiPSE - 1 initial data: Key takeaways CR: Complete Response Heavily pretreated and refractory patient population treated in first - in - human dose escalation trial, including 45 % patients who had received prior CAR T treatments Favorable initial safety profile; can be delivered in an outpatient setting Increased response rates at higher doses and observations of deepening responses with additional cycles. 83% ORR at Dose Level 3B Dose dependent increase in CNTY - 101 exposure observed CNTY - 101’s favorable initial safety profile, encouraging early efficacy and PK/PD data support study continuation Data for CNTY - 101 continues to support the potential for Allo - Evasion to enable a multi - dosing regimen in the presence of a restored endogenous immune system

 

 

23 Key differentiators of CNTY - 101 in autoimmune disease treatment CNTY - 101: CD - 19 targeted iNK cell therapy with 6 precision gene edits including Allo - Evasion technology • Ph1 CALiPSO - 1 trial in B cell - mediated autoimmune diseases (Systemic Lupus Erythematosus, Lupus Nephritis , Idiopathic Inflammatory Myopathy & Diffuse Cutaneous Systemic Sclerosis ) initiated in early 3Q24 • Currently being studied in Ph1 ELiPSE - 1 trial in R/R NHL Key differentiators in AID: (1) Allogeneic (2) NK cells (3) Allo - Evasion (2) NK cells • Killing potency ≥ primary CAR - T • Trafficking to secondary lymphoid tissues and marrow favors pathogenic B - cell targeting • Limited in vivo expansion (1) Allogeneic • Available “off - the - shelf” • No patient apheresis required • No manufacturing wait time • Platform enables lower COGs than donor - derived or autologous (3) Allo - Evasion • Avoiding host immune rejection • Ability to repeat dose without continued lymphodepletion • Ability to retreat, if needed Tighter control over drug exposure: B - cell depletion without prolonged B - cell aplasia

 

 

24 CNTY - 101: Potential to drive B - cell depletion with tighter control over drug exposure More potent than primary CAR - T at B - cell killing of SLE patient cells in preclinical comparison CNTY - 101 more potent than primary CAR - T cells at B - cell killing at 24 hours in preclinical comparison Isolated B cells or CD19+ target cells were co - cultured with CNTY - 101 or primary CAR - T at several E:Ts in 96 - well U bottom plate s in NKCM with assay harvested at 24h. Assay plates were harvested and stained for Fixable Live/Dead. Cells were fixed and run on cytometer to determine Target+Dead Cell populations. E:T: Effector: Target, UTD: Untransduced Donor

 

 

25 Opportunity in moderate to severe autoimmune indications to provide long term, drug free remission 1. Izmirly 2017, Duarte - Garcia - 2022, Lim 2014, Dall’Era 2017 . Approximately 40% of SLE patients have Lupus Nephritis 2. Fan 2020, Bairkdar 2021 3. Smoyer - Tomic 2012, Bernatsky 2009 4 . Mackensen Nature Medicine 2022 and Muller NEJM 2024 Estimated US prevalence of SLE 210 - 340K 1 including LN, SSc >80K 2 , IIM >60K 3 • Abnormal B cell function and autoantibody production are central to disease pathogenesis • Major causes of morbidity and mortality involve multiple vital organ systems • Renal, pulmonary, and cardiovascular Despite approved treatments, significant unmet need remains • Current treatments fail to significantly impact morbidity in many patients with moderate to severe disease • Chronic treatment with broad - acting immunosuppressives is standard • Treatment toxicity and disease flares remain common Autologous anti - CD19 CAR - T cell therapies show potential for promising efficacy 4 • Challenges remain due to potential exposure to CRS and ICANS, product availability, and long - term risks including B - cell aplasia

 

 

26 CNTY - 101: CALiPSO - 1 (NCT06255028) refractory B cell - mediated autoimmune diseases Phase 1 study Inclusion: • Participants with moderate to severe SLE , LN, IIM or dcSSc with treatment - resistant and active disease, after 2+ standard immunosuppressive therapies Endpoints: • Key endpoints: Safety and tolerability, disease activity measures per clinical and laboratory assessments • Translational endpoints : PK, B - cell depletion, autoantibody decline Cycle 1 Cycle 2 No lymphodepletion Schedule • Dose level: 1000e6 LYMPHO - DEPLETION 28 - DAY DLT PERIOD* Patient Enrollment Up to N= 48 101 DAY 1 DAY 8 101 101 DAY 15 101 DAY 1 DAY 8 101 101 DAY 15 RESPONSE ASSESSMENTS Months 2 - 12 *Response assessment conducted at one month; does not gate Cycle 2 DLT: Dose limiting toxicity

 

 

Discovery programs

 

 

28 Century’s robust pre - clinical pipeline has potential to address critical barriers confronting cellular therapies Multiple iPSC - derived immune effector cells: iPSC - enabled engineering solutions: ​ 28 Opportunity across multiple diseases: ​ 1 • Cytokine engineering to reduce or eliminate lymphodepletion • Enhanced Allo - Evasion enables repeat dosing, extended drug exposure and potential for durable remissions • Resistance to suppressive cytokines within the tumor • iNK • iT • iT (CD4+, CD8+) • Next - gen therapies for oncology: ​ ▪ CD19, CD19/22 CARs ▪ Nectin - 4 CAR ​ ▪ High - affinity Fc receptors (enable treatment with mAbs ​) • Key targets in autoimmune diseases : ​ ▪ CD19 and BCMA

 

 

Corporate position & upcoming milestones

 

 

30 Cash runway into 2H 2026 Ended 3 Q 24 with cash, cash equivalents, and investments of $244.7M Cash resources Differentiated pipeline based on Allo - Evasion technology x Potential to overcome limitations of conventional allogeneic cell therapy Encouraging preliminary clinical data from Phase 1 trial of CNTY - 101 in R/R B - cell lymphomas x 83% ORR at dose level 3B, with favorable safety profile x Data supports the ability to re - dose in the presence of a restored endogenous immune system x Study continuing with escalation to dose level 4B Expansion into additional autoimmune indications x CALiPSO - 1 trial initiated in SLE and LN; amended to include additional cohorts of IIM & dcSSc participants x CNTY - 101 has differentiated profile in AID (allogeneic, iNK with Allo - Evasion ) x Multiple pipeline opportunities in AID In - house manufacturing capabilities x Ability to accelerate learnings and enable faster product iteration Phase 1 ELiPSE - 1 trial of CNTY - 101 in B - cell malignancies • Updated clinical data expected by mid - 2025 Phase 1 CALiPSO - 1 trial of CNTY - 101 in B - cell mediated autoimmune diseases • Enrollment of patients across indications Pre - clinical pipeline prioritization • Conclusion of review expected in 1Q 2025 Advancing next - generation iPSC - derived allogeneic NK and T cell therapy candidates for the treatment of cancer and autoimmunity Multiple near - term catalysts 1

 

 

31 Century Therapeutics: Building an industry - leading, next - generation allogeneic iPSC - derived cell therapy platform Foundational investments in iPSC technology, genetic editing, protein engineering, and manufacturing Limitless Potential… Progressing differentiated clinical programs based on Allo - Evasion technology in oncology and autoimmune diseases Precision Design… Well - capitalized into 2H 2026 to enable delivery of key milestones and clinical data Enduring Impact… 1

 

 

Cover	Nov. 05, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 05, 2024
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
Written Communications	false
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

---