Cyclacel Pharmaceuticals Reports Third Quarter Financial Results and Provides Business Update
Cyclacel Pharmaceuticals reported Q3 2024 financial results, highlighting initial safety and efficacy data from twelve patients in Phase 2 study of fadraciclib. Cash equivalents were $3.0 million as of September 30, 2024, down from $3.4 million at end-2023. Net loss decreased to $2.0 million from $6.0 million year-over-year. R&D expenses reduced to $1.0 million from $5.2 million in Q3 2023. The company faces potential Nasdaq delisting unless it meets minimum stockholders' equity requirement by December 24, 2024. Current cash is expected to fund operations into Q4 2024, with substantial doubt about continuing as a going concern.
Cyclacel Pharmaceuticals ha riportato i risultati finanziari del terzo trimestre 2024, evidenziando i dati iniziali di sicurezza ed efficacia provenienti da dodici pazienti nello studio di Fase 2 su fadraciclib. Le disponibilità liquide ammontavano a 3,0 milioni di dollari al 30 settembre 2024, in calo rispetto ai 3,4 milioni di dollari alla fine del 2023. La perdita netta è diminuita a 2,0 milioni di dollari rispetto ai 6,0 milioni di dollari dell'anno precedente. Le spese per Ricerca e Sviluppo sono state ridotte a 1,0 milione di dollari rispetto ai 5,2 milioni di dollari nel terzo trimestre 2023. L'azienda rischia un possibile delisting da Nasdaq a meno che non soddisfi il requisito minimo di patrimonio netto entro il 24 dicembre 2024. Si prevede che le attuali disponibilità liquide possano sostenere le operazioni fino al quarto trimestre 2024, con notevoli dubbi sulla continuità aziendale.
Cyclacel Pharmaceuticals reportó los resultados financieros del tercer trimestre de 2024, destacando los datos iniciales de seguridad y eficacia de doce pacientes en un estudio de Fase 2 sobre fadraciclib. Los equivalentes de efectivo eran de 3,0 millones de dólares al 30 de septiembre de 2024, una disminución desde los 3,4 millones de dólares a finales de 2023. La pérdida neta se redujo a 2,0 millones de dólares desde 6,0 millones de dólares en comparación con el año anterior. Los gastos en I+D se redujeron a 1,0 millón de dólares desde 5,2 millones de dólares en el tercer trimestre de 2023. La compañía enfrenta un posible deslisting de Nasdaq a menos que cumpla con el requisito mínimo de patrimonio neto para el 24 de diciembre de 2024. Se espera que el efectivo actual financie las operaciones hasta el cuarto trimestre de 2024, con dudas significativas sobre su continuidad como empresa.
사이클라셀 제약(Cyclacel Pharmaceuticals)은 2024년 3분기 재무 결과를 발표하며, 파드라시클립(fadraciclib)의 2상 연구에서 12명의 환자에 대한 초기 안전성 및 유효성 데이터를 강조했습니다. 2024년 9월 30일 기준 현금 및 현금성 자산은 300만 달러로, 2023년 말 340만 달러에서 감소했습니다. 순손실은 작년 동기 대비 600만 달러에서 200만 달러로 감소했습니다. 연구 개발 비용은 2023년 3분기의 520만 달러에서 100만 달러로 줄었습니다. 이 회사는 2024년 12월 24일까지 최소 주주 자본 요건을 충족하지 않으면 나스닥에서의 상장 폐지 가능성에 직면해 있습니다. 현재의 현금은 2024년 4분기까지 운영 자금을 지원할 것으로 예상되지만 지속적인 기업 운영에 대한 상당한 의문이 제기됩니다.
Cyclacel Pharmaceuticals a publié ses résultats financiers pour le troisième trimestre 2024, mettant en avant des données initiales de sécurité et d'efficacité provenant de douze patients dans l'étude de Phase 2 portant sur fadraciclib. Les équivalents de cash s'élevaient à 3,0 millions de dollars au 30 septembre 2024, en baisse par rapport à 3,4 millions de dollars à la fin de 2023. La perte nette a diminué à 2,0 millions de dollars contre 6,0 millions de dollars l'année précédente. Les dépenses de R&D ont été réduites à 1,0 million de dollars contre 5,2 millions de dollars au troisième trimestre 2023. L'entreprise risque une radiation de la Nasdaq à moins qu'elle ne respecte l'exigence minimale de capitaux propres d'ici le 24 décembre 2024. Il est prévu que les liquidités actuelles financent les opérations jusqu'au quatrième trimestre 2024, avec d'importants doutes sur sa continuité en tant qu'entité.
Cyclacel Pharmaceuticals hat die finanziellen Ergebnisse für das dritte Quartal 2024 veröffentlicht, wobei erste Sicherheits- und Wirksamkeitsdaten von zwölf Patienten aus der Phase-2-Studie zu fadraciclib hervorgehoben wurden. Die Zahlungsmitteläquivalente betrugen zum 30. September 2024 3,0 Millionen US-Dollar, ein Rückgang von 3,4 Millionen US-Dollar Ende 2023. Der Nettoverlust verringerte sich von 6,0 Millionen US-Dollar im Vorjahr auf 2,0 Millionen US-Dollar. Die F&E-Ausgaben sanken von 5,2 Millionen US-Dollar im dritten Quartal 2023 auf 1,0 Million US-Dollar. Das Unternehmen sieht sich einer möglichen Delistung von Nasdaq gegenüber, es sei denn, es erfüllt die Mindestanforderungen an das Eigenkapital bis zum 24. Dezember 2024. Es wird erwartet, dass die aktuellen Zahlungsmittel die Betriebstätigkeit bis ins vierte Quartal 2024 finanzieren, wobei erhebliche Zweifel an der Fortführung des Unternehmens bestehen.
- Net loss decreased by 67% to $2.0 million from $6.0 million YoY
- R&D expenses reduced by 81% to $1.0 million from $5.2 million YoY
- Operating cash burn reduced to $6.6 million from $12.2 million for nine months
- Cash position declined to $3.0 million from $3.4 million at end-2023
- Risk of Nasdaq delisting if minimum stockholders' equity requirement not met by December 24, 2024
- Substantial doubt about company's ability to continue as going concern
- Current cash only sufficient to fund operations into Q4 2024
- Potential bankruptcy risk if additional funding not secured
Insights
The Q3 report reveals severe financial distress at Cyclacel Pharmaceuticals. With only
Three critical red flags demand attention: 1) The explicit going concern warning from management, 2) The looming Nasdaq compliance deadline of December 24, 2024 and 3) Cash runway only extending into Q4 2024. Without immediate additional funding, bankruptcy is a real possibility. The
BERKELEY HEIGHTS, N.J., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines, today announced third quarter financial results and provided a business update.
“We were pleased to report initial safety and efficacy data from twelve patients with advanced solid tumors enrolled in the Phase 2 part of the 065-101, proof of concept, clinical study of fadraciclib as a single agent as a poster presentation at the 2024 EORTC-NCI-AACR 36th Symposium on Molecular Targets and Cancer Therapeutics (“Triple Meeting”), in Barcelona, Spain. The patients were enrolled in the biomarker-enriched, Cohort 8 of the study and were preselected for CDKN2A and/or CDKN2B abnormalities,” said Spiro Rombotis, President and Chief Executive Officer. “Nasdaq has granted the Company an extension until December 24, 2024, to regain compliance with Nasdaq’s minimum stockholders’ equity requirement and we continue to pursue opportunities to obtain additional funding for our programs. If we do not secure such additional funding in an amount that allows us to meet or exceed Nasdaq’s minimum stockholders’ equity requirement, our securities will be delisted from Nasdaq.”
Financial Highlights
As of September 30, 2024, cash equivalents totaled
Although the Company has made substantial reductions in its expenses, there remains substantial doubt about our ability to continue as a going concern. We are currently investigating ways to raise additional capital through private equity financing or by entering into a strategic transaction. In the event that we are not able to secure such additional funding, we may be forced to curtail operations, delay or stop ongoing development activities, cease operations altogether, and/or file for bankruptcy. In such events, our stockholders may lose their entire investment in the Company.
Research and development (R&D) expenses were
General and administrative expenses for the three months ended September 30, 2024 were
Total other income, net, for the three months ended September 30, 2024 was
United Kingdom research & development tax credits for the three months ended September 30, 2024 were
Net loss for the three months ended September 30, 2024 was
About Cyclacel Pharmaceuticals, Inc.
Cyclacel is a clinical-stage, biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and mitosis biology. The transcriptional regulation program is evaluating fadraciclib, a CDK2/9 inhibitor, and the anti-mitotic program plogosertib, a PLK1 inhibitor, in patients with both solid tumors and hematological malignancies. Cyclacel's strategy is to build a diversified biopharmaceutical business based on a pipeline of novel drug candidates addressing oncology and hematology indications. For additional information, please visit www.cyclacel.com.
Forward-looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include, among other things, statements related to the efficacy and safety profile of fadraciclib in an incomplete clinical trial, Cyclacel’s future plans and prospects, Cyclacel’s anticipated cash runway and its ability to secure additional funding and the planned timing of data results and continued development of fadraciclib. Factors that may cause actual results to differ materially include market and other conditions, the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have difficulty enrolling, Cyclacel may not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates and Cyclacel’s ability to regain and maintain compliance with Nasdaq’s continued listing requirements, although no assurance to that effect can be given. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we file with the Securities and Exchange Commission and are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts
| Company: | Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com |
© Copyright 2024 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.
SOURCE: Cyclacel Pharmaceuticals, Inc.
| CYCLACEL PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (LOSS) (In | |||||||||||
| Three Months Ended | |||||||||||
| September 30, | |||||||||||
| 2024 | 2023 | ||||||||||
| Revenues: | |||||||||||
| Collaboration and research and development revenue | 10 | 16 | |||||||||
| Revenues | $ | 10 | $ | 16 | |||||||
| Operating expenses: | |||||||||||
| Research and development | 950 | 5,236 | |||||||||
| General and administrative | 1,237 | 1,625 | |||||||||
| Total operating expenses | 2,187 | 6,861 | |||||||||
| Operating loss | (2,177 | ) | (6,845 | ) | |||||||
| Other income (expense): | |||||||||||
| Foreign exchange gains (losses) | 2 | 104 | |||||||||
| Interest income | 8 | 50 | |||||||||
| Other income, net | - | (9 | ) | ||||||||
| Total other income (expense), net | 10 | 145 | |||||||||
| Loss before taxes | (2,167 | ) | (6,700 | ) | |||||||
| Income tax benefit | 210 | 668 | |||||||||
| Net loss | (1,957 | ) | (6,032 | ) | |||||||
| Dividend on convertible exchangeable preferred shares | - | (50 | ) | ||||||||
| Net loss applicable to common shareholders | $ | (1,957 | ) | $ | (6,082 | ) | |||||
| Basic and diluted earnings per common share: | |||||||||||
| Net loss per share – basic and diluted (common shareholders) | $ | (0.18 | ) | $ | (0.48 | ) | |||||
| Net loss per share – basic and diluted (redeemable common shareholders) | $ | - | $ | (0.48 | ) | ||||||
| CYCLACEL PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEET (In | |||||||||||
| September 30, | December 31, | ||||||||||
| 2024 | 2023 | ||||||||||
| ASSETS | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 2,982 | $ | 3,378 | |||||||
| Prepaid expenses and other current assets | 1,931 | 4,066 | |||||||||
| Total current assets | 4,913 | 7,444 | |||||||||
| Property and equipment, net | 4 | 9 | |||||||||
| Right-of-use lease asset | 51 | 93 | |||||||||
| Non-current deposits | 413 | 1,259 | |||||||||
| Total assets | $ | 5,381 | $ | 8,805 | |||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 4,126 | $ | 3,543 | |||||||
| Accrued and other current liabilities | 2,225 | 4,618 | |||||||||
| Total current liabilities | 6,351 | 8,161 | |||||||||
| Lease liability | - | 37 | |||||||||
| Total liabilities | 6,351 | 8,198 | |||||||||
| Stockholders’ equity | (970 | ) | 607 | ||||||||
| Total liabilities and stockholders’ equity | $ | 5,381 | $ | 8,805 | |||||||
FAQ
What is Cyclacel's (CYCC) cash position as of Q3 2024?
What was CYCC's net loss in Q3 2024?
When might CYCC face Nasdaq delisting?
How long will CYCC's current cash last?
