On May 9, 2024 Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune diseases, reported financial results and business highlights for the first quarter ended March 31, 2024 (Press release, Century Therapeutics, MAY 9, 2024, View Source [SID1234642982]).
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"We have made significant clinical, operational and research-oriented progress so far this year, and I am incredibly excited by the momentum we’ve been able to achieve in such a short period of time," said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics. "Looking ahead, we will be sharing additional clinical data from the ELiPSE-1 trial of CNTY-101 in R/R NHL at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting in June. In addition, we are on track to initiate the Phase 1 CALiPSO-1 trial of CNTY-101 in SLE in the first half of 2024, while also continuing to progress the multiple planned regulatory filings for CNTY-101 in additional autoimmune disease indications later this year. We believe Century’s position as a leader in allogeneic, iPSC-derived cell therapy is fortified by the recent expansion of our pipeline and platform capabilities through the acquisition of Clade Therapeutics, and we are looking forward to continued execution across our robust portfolio of novel assets providing us with multiple near- and long-term potential value drivers."
Research and Development Highlights and Upcoming Milestones
CNTY-101
CNTY-101 is a CD19 targeting allogeneic iNK cell therapy with 6 precision gene edits powered by Century’s Allo-Evasion technology, which enables repeat dosing without the need for continued lymphodepletion. Century’s core Allo-Evasion edits are designed to overcome the three major pathways of host versus graft rejection: CD8+ T cells, CD4+ T cells and NK cells.
· In April 2024, the Company announced plans to expand clinical development of CNTY-101 into additional autoimmune disease indications beyond SLE. In the second half of 2024, Century intends to submit additional regulatory filings for CNTY-101 in autoimmune disease indications with limited current treatment options and high unmet need. Additionally, the Company is planning to evaluate CNTY-101 for SLE in the Phase 1 CALiPSO-1 trial, which is on track to be initiated in the first half of 2024 with preliminary data expected by the end of 2024.
· Century plans to share additional data from its Phase 1 ELiPSE-1 trial in R/R non-Hodgkin lymphoma (NHL) at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting, being held May 31-June 4, 2024, in Chicago, IL. As previously announced, in this heavily pretreated and refractory patient population, CNTY-101 has demonstrated a favorable safety profile in the initial seven patients treated with Dose Level 1 (100 million cells) and Dose Level 2 (300 million cells) on a once monthly schedule. In these low dose levels, CNTY-101 demonstrated encouraging early response signals, including two complete responses (CRs) and one partial response (PR). Initial translational data supports the potential for Allo-Evasion to enable a multidose regimen without the need for continued lymphodepletion.
Platform Technology and Additional Pipeline Programs
· In April 2024, Century shared six poster presentations at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting showcasing new preclinical data on additional Allo-Evasion edits in addition to the Company’s end-to-end cell therapy capabilities including expertise across iPSC reprogramming, gene editing, protein engineering, Allo-Evasion technology and computational biology. Key abstracts highlighted Century’s novel, dual-targeting CAR for B-cell mediated malignancies demonstrating in vitro and in vivo cytotoxicity and antigen loss resistance; and new data on the Allo-Evasion platform showcasing its potential to evade identification by the host immune system, which would allow for repeat dosing without rejection, enabling increased persistence of the cells during the treatment period and potentially leading to deeper and more durable responses. Across all six posters, the findings highlight Century’s unique gene editing, protein engineering, and manufacturing capabilities that are the foundations of its allogeneic cell therapy pipeline and platform. The presented posters are available at the Scientific Resources page of the Company’s website.
· In April 2024, the Company announced the acquisition of Clade Therapeutics, a privately held biotech company focused on discovering and delivering engineerable, off-the-shelf, scalable, and consistent stem cell-based medicines, with a focus on iPSC-derived αβ T cells. This acquisition brings complementary technology to enhance Century’s Allo-Evasion platform and additional next-generation iT programs spanning targets in cancer, and autoimmune diseases. These programs include CLDE-308, an αβ iT cell program targeting CD19 in autoimmune disease and B-cell malignancies, CLDE-361, an αβ iT cell program targeting BCMA in myasthenia gravis, and an undisclosed iT cell focused research program in solid tumors.
Business Highlights
· In April 2024, the Company entered into a securities purchase agreement with a select group of institutional investors for an approximately $60 million private placement of its common stock. The private placement closed on April 15, 2024, and was led by new investors Bain Capital Life Sciences, Adage Capital Partners LP, Octagon Capital, and Superstring Capital, and existing investors including Casdin Capital, Boxer Capital, Venrock Healthcare Capital Partners and DAFNA Capital Management, LLC.
First Quarter 2024 Financial Results
· Cash Position: Cash, cash equivalents, and marketable securities were $249.9 million as of March 31, 2024, as compared to $261.8 million as of December 31, 2023. Net cash used in operations was $30.2 million for the three months ended March 31, 2024, compared to net cash used in operations of $29.2 million for the three months ended March 31, 2023.
· Collaboration Revenue: Collaboration revenue generated through the Company’s collaboration, option and license agreement with Bristol-Myers Squibb (BMS) was $0.9 million for the three months ended March 31, 2024, compared to $1.7 million for the same period in 2023.
· Research and Development (R&D) expenses: R&D expenses were $23.4 million for the three months ended March 31, 2024, compared to $24.9 million for the same period in 2023. The decrease in R&D expenses was primarily due to the reduction in force that occurred in January of 2023.
· General and Administrative (G&A) expenses: G&A expenses were $8.7 million for the three months ended March 31, 2024, compared to $8.9 million for the same period in 2023.
· Net loss: Net loss was $28.1 million for the three months ended March 31, 2024, compared to $31.3 million for the three months ended March 31, 2023.
Financial Guidance
· The Company expects full year generally accepted accounting principles (GAAP) operating expenses to be between $150 million and $160 million as compared to the previous guidance range of $135 million to $145 million. The increase is driven by additional operating expenses related to the integration of Clade Therapeutics, as well as the Company’s planned expanded clinical development of CNTY-101 into additional autoimmune disease indications. The Company is currently in the process of completing its accounting analysis of the acquisition of Clade. The revised guidance does not include any potential non-cash charges related to the acquisition.
· The Company estimates its cash, cash equivalents, and investments will support operations into 2026.