Century Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Updates
Century Therapeutics (NASDAQ: IPSC) reported Q2 2024 financial results and business updates. Key highlights include:
1. Initiation of Phase 1 CALiPSO-1 trial of CNTY-101 in Systemic Lupus Erythematosus, expanding into autoimmune diseases.
2. Presented interim results from Phase 1 ELiPSE-1 trial of CNTY-101, showing encouraging efficacy and tolerability in relapsed/refractory B-cell lymphomas.
3. Completed dose escalation for ELiPSE-1, advancing to dose expansion in 2H 2024.
4. Q2 2024 ended with $269.6 million in cash, cash equivalents, and investments.
5. Net loss of $31.2 million for Q2 2024.
6. Full-year GAAP operating expenses expected between $150-160 million.
7. Cash runway extended into 2026.
Century Therapeutics (NASDAQ: IPSC) ha riportato i risultati finanziari del secondo trimestre 2024 e aggiornamenti aziendali. I punti salienti includono:
1. Inizio della fase 1 dello studio CALiPSO-1 di CNTY-101 nella Lupus Eritematoso Sistemico, espandendosi nelle malattie autoimmuni.
2. Presentati risultati intermedi dalla fase 1 dello studio ELiPSE-1 di CNTY-101, mostrando un'efficacia e una tollerabilità incoraggianti nei linfomi a cellule B recidivanti/riflessivi.
3. Completata l'escalation della dose per ELiPSE-1, avanzando verso l'espansione della dose nel secondo semestre del 2024.
4. Il secondo trimestre 2024 si è concluso con 269,6 milioni di dollari in contante, equivalenti in contante e investimenti.
5. Per il secondo trimestre 2024, una perdita netta di 31,2 milioni di dollari.
6. Si prevede che le spese operative GAAP per l'intero anno siano comprese tra 150 e 160 milioni di dollari.
7. La disponibilità di cassa è stata estesa fino al 2026.
Century Therapeutics (NASDAQ: IPSC) informó sobre los resultados financieros del segundo trimestre de 2024 y las actualizaciones comerciales. Los aspectos más destacados incluyen:
1. Inicio del ensayo de fase 1 CALiPSO-1 de CNTY-101 en Lupus Eritematoso Sistémico, expandiéndose hacia enfermedades autoinmunitarias.
2. Presentación de resultados intermedios del ensayo de fase 1 ELiPSE-1 de CNTY-101, mostrando una eficacia y tolerabilidad alentadoras en linfomas de células B en recaída/refractarios.
3. Completada la escalada de dosis para ELiPSE-1, avanzando hacia la expansión de dosis en la segunda mitad de 2024.
4. El segundo trimestre de 2024 terminó con 269,6 millones de dólares en efectivo, equivalentes de efectivo e inversiones.
5. Pérdida neta de 31,2 millones de dólares para el segundo trimestre de 2024.
6. Se espera que los gastos operativos GAAP de todo el año estén entre 150 y 160 millones de dólares.
7. La tesorería se ha extendido hasta 2026.
센추리 테라퓨틱스 (NASDAQ: IPSC)는 2024년 2분기 재무 결과 및 비즈니스 업데이트를 보고했습니다. 주요 하이라이트는:
1. 자가면역 질환으로 확장되는 CNTY-101의 전신 홍반 루푸스에 대한 CALiPSO-1 1상 시험 시작.
2. 재발/불응성 B세포 림프종에서 CNTY-101의 1상 ELiPSE-1 시험의 중간 결과를 발표하며 긍정적인 효능과 내약성을 보여줌.
3. ELiPSE-1의 용량 증가 완료, 2024년 하반기로 용량 확대로 진행.
4. 2024년 2분기가 종료되며 현금, 현금 등가물 및 투자가 2억 6천 9백 60만 달러로 마감됨.
5. 2024년 2분기 순손실 3천 1백 20만 달러.
6. 연간 GAAP 운영 비용이 1억 5천만에서 1억 6천만 달러 사이로 예상됨.
7. 현금 유동성이 2026년까지 연장됨.
Century Therapeutics (NASDAQ: IPSC) a publié les résultats financiers du deuxième trimestre 2024 et des mises à jour commerciales. Les points clés incluent:
1. Lancement de l'essai de phase 1 CALiPSO-1 de CNTY-101 dans le lupus érythémateux systémique, s'étendant aux maladies auto-immunes.
2. Présentation des résultats intermédiaires de l'essai de phase 1 ELiPSE-1 de CNTY-101, montrant une efficacité et une tolérance encourageantes dans les lymphomes B récidivants/réfractaires.
3. Finalisation de l'escalade de dose pour ELiPSE-1, passant à l'expansion de dose au second semestre 2024.
4. Le deuxième trimestre 2024 s'est terminé avec 269,6 millions de dollars en espèces, équivalents d'espèces et investissements.
5. Perte nette de 31,2 millions de dollars pour le deuxième trimestre 2024.
6. Les dépenses d'exploitation GAAP pour l'ensemble de l'année devraient se situer entre 150 et 160 millions de dollars.
7. La liquidité a été prolongée jusqu'en 2026.
Century Therapeutics (NASDAQ: IPSC) hat die finanziellen Ergebnisse des zweiten Quartals 2024 und Unternehmensaktualisierungen berichtet. Die wichtigsten Highlights sind:
1. Beginn der Phase-1-Studie CALiPSO-1 zu CNTY-101 bei systemischem Lupus erythematodes, mit einer Ausweitung auf Autoimmunerkrankungen.
2. Präsentation interims Ergebnisse der Phase-1-Studie ELiPSE-1 zu CNTY-101, die ermutigende Wirksamkeit und Verträglichkeit bei rezidivierenden/refraktären B-Zell-Lymphomen zeigen.
3. Abschluss der Dosissteigerung für ELiPSE-1, mit weiterer Fortschreitung zur Dosisexpansion im zweiten Halbjahr 2024.
4. Das zweite Quartal 2024 endete mit 269,6 Millionen US-Dollar in Bar, liquiditätsähnlichen Mitteln und Investitionen.
5. Nettoraus in Höhe von 31,2 Millionen US-Dollar für das zweite Quartal 2024.
6. Die GAAP-Betriebskosten für das gesamte Jahr werden auf 150 bis 160 Millionen US-Dollar geschätzt.
7. Die Cash-Runway wurde bis 2026 verlängert.
- Initiation of Phase 1 CALiPSO-1 trial for CNTY-101 in Systemic Lupus Erythematosus, expanding into autoimmune diseases
- Encouraging interim results from Phase 1 ELiPSE-1 trial of CNTY-101 in relapsed/refractory B-cell lymphomas
- Completed dose escalation for ELiPSE-1, advancing to dose expansion in 2H 2024
- Strong cash position of $269.6 million as of June 30, 2024
- Cash runway extended into 2026
- Collaboration revenue increased to $0.8 million in Q2 2024 from $0.1 million in Q2 2023
- Net loss of $31.2 million for Q2 2024
- Increased R&D expenses of $27.2 million in Q2 2024 compared to $22.7 million in Q2 2023
- Net cash used in operations increased to $57.6 million for H1 2024 from $48.5 million in H1 2023
Insights
Century Therapeutics' Q2 2024 results show mixed financial performance. Revenue increased to
The company's cash position remains strong at
Century Therapeutics is making significant strides in cell therapy development. The initiation of the CALiPSO-1 trial for CNTY-101 in Systemic Lupus Erythematosus (SLE) marks a strategic expansion into autoimmune diseases. The protocol amendment to include Lupus Nephritis patients demonstrates adaptability and potential for broader application. This move could position Century as a frontrunner in allogeneic cell therapies for autoimmune conditions.
The interim results from the ELiPSE-1 trial of CNTY-101 in relapsed/refractory B-cell lymphomas are particularly encouraging. With no observed dose-limiting toxicities or graft-versus-host disease and responses across escalating doses, CNTY-101 shows promise in terms of both safety and efficacy. The completion of dose escalation and advancement to dose expansion in 2H 2024 suggests confidence in the therapy's potential. However, it's important to await more comprehensive data to fully assess CNTY-101's efficacy and long-term safety profile.
Century Therapeutics' strategic pivot into autoimmune diseases, particularly with CNTY-101, could significantly expand its market potential. The global autoimmune disease therapeutics market is projected to reach
The company's focus on allogeneic iPSC-derived cell therapies, equipped with their proprietary Allo-Evasion™ technology, differentiates them in a competitive landscape. This approach could lead to more controlled, durable and tolerable therapies, potentially capturing market share from traditional treatments. However, investors should be aware that cell therapies face challenges in manufacturing scalability and cost-effectiveness. Century's ability to overcome these hurdles will be important for long-term success and market adoption. The planned additional regulatory filings for CNTY-101 in other autoimmune indications could further broaden their market reach, but also increase development costs in the near term.
– Initiation of Phase 1 CALiPSO-1 Trial of CNTY-101 in Systemic Lupus Erythematosus, marking strategic expansion into autoimmune disease; protocol amended to include additional cohort of Lupus Nephritis patients –
– Presented interim results from Phase 1 ELiPSE-1 trial of CNTY-101 demonstrating encouraging preliminary efficacy and tolerability data in heavily pretreated relapsed/refractory –
– Completed dose escalation for ELiPSE-1 and advancing into dose expansion in 2H 2024 –
– Ended second quarter 2024 with cash, cash equivalents, and investments of
PHILADELPHIA, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Century Therapeutics, Inc. (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 second quarter ended June 30, 2024.
“Our strategic autoimmune expansion, as highlighted by the recent initiation of the CALiPSO-1 trial in Systemic Lupus Erythematosus and addition of a Lupus Nephritis-specific cohort, positions Century as a potential leader in allogeneic cell therapies for autoimmune diseases. 2024 remains a time of focused execution as we work to advance our next-generation allogeneic iPSC-derived cell therapy platform and pipeline, equipped with our proprietary Allo-Evasion™ technology, capturing a diversified opportunity to address a broad range of indications with high unmet need. I am proud of the significant progress we have achieved in such a short period of time, particularly underscored by the evolution of our platform and capabilities, which we anticipate will enable our iPSC candidates to have a more controlled, durable, and tolerable profile,” said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics. “We remain focused on progressing CNTY-101 in both of our clinical-stage programs, including advancement into dose expansion in the ELiPSE-1 trial in patients with r/r B-cell lymphomas and acceleration of patient enrollment following the recent initiation of the CALiPSO-1 trial. We’ve made strides in our initial execution of autoimmune expansion as evidenced by our CALiPSO-1 trial updates, while simultaneously pursuing additional regulatory filings for CNTY-101 in other autoimmune disease indications in the second half of the year. We look forward to continued execution and the opportunity to deliver on our next set of potential catalysts, including the expectation of initial clinical data from CALiPSO-1 by year-end.”
Research & Development Highlights
- Consistent with Century’s autoimmune disease expansion efforts announced in April 2024, the Company recently initiated the Phase 1 CALiPSO-1 trial of CNTY-101 (NCT06255028) in Systemic Lupus Erythematosus (SLE). The first clinical trial site has been activated, with additional sites continuing to open across the United States. The Company expects initial clinical data from CALiPSO-1 by year-end 2024. Furthermore, Century recently amended the protocol to include a new indication-specific cohort of Lupus Nephritis (LN) patients. CALiPSO-1 is an open-label multi-center clinical trial to evaluate the safety, tolerability, pharmacokinetics, and clinical response of CNTY-101 in patients with moderate to severe SLE and LN who have failed at least two standard immunosuppressive therapies. The inclusion of LN patients highlights Century’s execution in pursuing additional regulatory filings as a way of accelerating and broadening its research and development initiatives in autoimmune diseases. The Company intends to submit additional regulatory filings for CNTY-101 in autoimmune disease indications with limited current treatment options and high unmet need in the second half of 2024.
- In May 2024, Century presented two posters at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting showcasing the potential ability of its lead program, CNTY-101, a CD19 targeting allogeneic iNK cell therapy with 6 precision gene edits powered by Century’s Allo-Evasion™ technology, to treat B-Cell driven autoimmune diseases including SLE, and new preclinical data demonstrating the potential utility of using a novel synthetic ligand targeting CD300a as a universal strategy for preventing natural killer (NK) cell mediated rejection in allogeneic cell therapies. The Company believes that these capabilities demonstrate the potential protection of allogeneic cell therapies with the possibility for improved outcomes, while delivering a broadly beneficial treatment option across a range of indications.
- In June 2024, the Company presented encouraging interim efficacy and safety data from the ongoing Phase 1 ELiPSE-1, multicenter, open-label clinical trial of CNTY-101 (NCT05336409) in heavily pre-treated patients with R/R CD19-positive B-cell lymphomas at the American Society of Clinical Oncology (ASCO) Annual Meeting. Evaluable preliminary safety (n=12) and efficacy (n=10) as of the data cutoff date of March 27, 2024, from the ongoing dose escalation portion of the trial, demonstrated a manageable tolerability profile with no observed dose limiting toxicities (DLT) or graft-versus-host disease (GvHD). After rapidly trafficking out of circulation, pharmacokinetics (PK), evaluated by a novel cell-free DNA method, showed that CNTY-101 persistence outside the bloodstream trended with increases in dose. Data also showed additional responses across escalating doses and different types of B-cell malignancies in heavily pretreated patients with predominantly aggressive or high-risk histologies.
- The Company recently completed dose escalation of schedule A (single dose per cycle) and schedule B (3 doses per cycle) in the ELiPSE-1 trial and is currently enrolling patients in the dose confirmation portion. Progression into dose expansion is expected in the second half of 2024.
Corporate Highlights
- In April 2024, the Company completed a private placement of common stock with gross proceeds of
$60 million with new and existing investors. Also in April 2024, the Company closed the acquisition of Clade Therapeutics, bringing enhancement of its Allo-Evasion™ platform and adding three preclinical stage αβ iT programs spanning across cancer and autoimmune diseases to its pipeline.
Second Quarter 2024 Financial Results
- Cash Position: Cash, cash equivalents, and marketable securities were
$269.6 million as of June 30, 2024, as compared to$261.8 million as of December 31, 2023. Net cash used in operations was$57.6 million for the six months ended June 30, 2024, compared to net cash used in operations of$48.5 million for the six months ended June 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 June 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 June 30, 2024, compared to$22.7 million for the same period in 2023. The increase in R&D expenses was primarily due to increased manufacturing activity for CNTY-101 and the acquisition of Clade Therapeutics. - General and Administrative (G&A) expenses: G&A expenses were
$8.3 million for the three months ended June 30, 2024, compared to$8.2 million for the same period in 2023. - Net loss: Net loss was
$31.2 million for the three months ended June 30, 2024, compared to$33.3 million for the three months ended June 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 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.
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; the ability of CNTY-101 to be administered as part of a multi-dose strategy and to enable responses without lymphodepletion; 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; the timing of and our ability to successfully enroll the Phase 1 SLE and LN trial; the timing of and our ability to enter dose expansion of the Phase 1 R/R CD19-positive B-cell lymphomas trial; 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
917-969-3438
Argot Partners
Julie Seidel/Noor Pahlavi
212-600-1902
| Century Therapeutics, Inc | ||||||||
| Condensed Balance Sheets | ||||||||
| (unaudited, in thousands) | ||||||||
| June 30, | December 31, | |||||||
| Assets | 2024 | 2023 | ||||||
| Current Assets: | $ | $ | ||||||
| Cash and cash equivalents | 41,457 | 47,324 | ||||||
| Short-term investments | 154,945 | 125,414 | ||||||
| Prepaid expenses and other current assets | 7,076 | 4,256 | ||||||
| Total current assets | 203,478 | 176,994 | ||||||
| Property and equipment, net | 69,405 | 71,705 | ||||||
| Operating lease right-of-use assets, net | 28,570 | 20,376 | ||||||
| Long-term investments | 73,226 | 89,096 | ||||||
| Goodwill | 5,091 | - | ||||||
| Intangible assets | 33,300 | - | ||||||
| Other long-term assets | 3,376 | 2,520 | ||||||
| Total assets | $ | 416,446 | $ | 360,691 | ||||
| Liabilities, convertible preferred stock, and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,358 | $ | 2,741 | ||||
| Accrued expenses and other liabilities | 11,445 | 10,733 | ||||||
| Long-term debt, current | - | - | ||||||
| Deferred revenue, current | 4,360 | 4,372 | ||||||
| Total current liabilities | 19,163 | 17,846 | ||||||
| Operating lease liability, noncurrent | 52,713 | 46,658 | ||||||
| Other long-term liabilities | 3,386 | 56 | ||||||
| Deferred revenue | 109,768 | 111,381 | ||||||
| Contingent consideration liability | 9,312 | - | ||||||
| Total liabilities | 194,342 | 175,941 | ||||||
| Stockholders' equity | ||||||||
| Common stock | 8 | 6 | ||||||
| Additional paid-in capital | 937,445 | 840,407 | ||||||
| Accumulated deficit | (715,040 | ) | (655,771 | ) | ||||
| Accumulated other comprehensive loss | (309 | ) | 108 | |||||
| Total stockholders' equity | 222,104 | 184,750 | ||||||
| Total liabilities and stockholders' equity | $ | 416,446 | $ | 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 | Six Months Ended | Six Months Ended | ||||||||||||
| June 30, 2024 | June 30, 2023 | June 30, 2024 | June 30, 2023 | ||||||||||||
| Collaboration Revenue | $ | 771 | $ | 99 | $ | 1,625 | $ | 1,819 | |||||||
| Operating Expenses | |||||||||||||||
| Research and development | 27,220 | 22,727 | 50,641 | 47,626 | |||||||||||
| General and administrative | 8,306 | 8,229 | 17,052 | 17,131 | |||||||||||
| Impairment on long-lived assets | - | 4,220 | - | 4,220 | |||||||||||
| Total operating expenses | 35,526 | 35,176 | 67,693 | 68,977 | |||||||||||
| Loss from operations | (34,755 | ) | (35,077 | ) | (66,068 | ) | (67,158 | ) | |||||||
| Interest expense | - | (136 | ) | - | (540 | ) | |||||||||
| Interest income | 3,582 | 3,058 | 6,820 | 5,681 | |||||||||||
| Other income, net | (12 | ) | (186 | ) | 1 | (380 | ) | ||||||||
| Loss before provision for income taxes | (31,185 | ) | (32,341 | ) | (59,247 | ) | (62,397 | ) | |||||||
| Provision for income taxes | (22 | ) | (950 | ) | (22 | ) | (2,158 | ) | |||||||
| Net Loss | $ | (31,207 | ) | $ | (33,291 | ) | $ | (59,269 | ) | $ | (64,555 | ) | |||
| Unrealized (loss) gain on investments | (102 | ) | 59 | (453 | ) | 1,255 | |||||||||
| Foreign currency translation adjustment gain (loss) | 35 | 9 | 36 | - | |||||||||||
| Comprehensive loss | $ | (31,274 | ) | $ | (33,223 | ) | $ | (59,686 | ) | $ | (63,300 | ) | |||
| Net loss per common share - Basic and Diluted | (0.38 | ) | (0.56 | ) | 0.82 | (1.10 | ) | ||||||||
| Weighted average common shares outstanding | 82,092,167 | 59,251,363 | 72,194,402 | 58,904,726 | |||||||||||
FAQ
What were Century Therapeutics' (IPSC) key clinical developments in Q2 2024?
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How did Century Therapeutics (IPSC) expand its research into autoimmune diseases in Q2 2024?
