- Phase 3 study of oral sapacitabine capsules alternating with intravenous decitabine compared to decitabine alone, as first-line treatment in patients aged 70 years or older with AML who are unfit for or refused intensive chemotherapy; cleaned and validated dataset being finalized and database lock imminent.
- The Phase 1 combination of sapacitabine and seliciclib is continuing enrollment in an extension study in an enriched population of BRCA positive patients with advanced breast cancer.
- Continued recruitment in Phase 1, first-in-human trial of CYC065, a CDK2/9 inhibitor, to evaluate safety, tolerability and pharmacokinetics in patients with solid tumors. The sixth dose escalation level has been reached.
- Preclinical data presented at the Childhood Cancer Meeting 2016 demonstrated effectiveness of CYC065 against neuroblastoma models with an overexpression and amplification of MYCN, a driver of neuroblastoma.
- Report top-line data and determination of submissibility to regulatory authorities, anticipated late fourth quarter 2016 or early 2017.
- Progress the Paediatric Investigation Plan for sapacitabine with the European Medicines Agency.
- Progress Phase 1 sapacitabine and seliciclib extension cohort in a breast cancer patient population enriched for BRCA mutations.
- Initiate Phase 1 part 3, to include BRCA mutation positive, pancreatic and ovarian cancer patients.
- Report top-line results of the CYC065 Phase 1 trial in patients with solid tumors.
- Report data when available from ongoing investigator sponsored trials (ISTs) evaluating seliciclib in patients with Cushing's disease and rheumatoid arthritis. Additionally, seliciclib is being evaluated in cystic fibrosis though a license and supply agreement with ManRos Therapeutics.
- Plan Phase 1/2 trial of sapacitabine in combination with other agents to determine safety and tolerability.
- Plan a Phase 2 randomized controlled trial (RCT) of sapacitabine in combination with other agents following review of all relevant clinical data with mature follow-up.
Revenue for the three months ended September 30, 2016 was $0.2 million, compared to $0.7 million for the same period of the previous year, with the decrease primarily related to grant revenue related to CYC065, for which the grant ended in December 2015.Research and development expenses were $2.4 million for the three months ended September 30, 2016 and $2.9 million for the three months ended September 30, 2015. General and administrative expenses were $1.3 million for the three months ended September 30, 2016 and $1.2 million for the three months ended September 30, 2015. CONFERENCE CALL AND WEBCAST INFORMATION: Cyclacel will conduct a conference call on November 14, 2016 at 4:30 p.m. Eastern Time to review the third quarter 2016 results. Conference call and webcast details are as follows:
|Conference call information:|
|US/Canada call: (877) 493-9121 / international call: (973) 582-2750|
|US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406|
|Code for live and archived conference call is 14223368|
|CYCLACEL PHARMACEUTICALS, INC.|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In $000s, except share and per share amounts)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Collaboration and research and development revenue||253||—||253||—|
|Research and development||2,904||2,409||9,826||7,545|
|General and administrative||1,205||1,273||4,006||4,002|
|Total operating expenses||4,109||3,682||13,832||11,547|
|Other income (expense):|
|Change in valuation of financial instruments associated with stock purchase agreement||(27||)||—||(51||)||—|
|Foreign exchange (loss) gain||(219||)||51||(354||)||369|
|Other income, net||13||18||95||56|
|Total other income (expense)||207||77||(305||)||456|
|Loss before taxes||(3,187||)||(3,400||)||(12,614||)||(10,525||)|
|Income tax benefit||478||454||1,646||1,573|
|Dividend on convertible exchangeable preferred shares||(50||)||(50||)||(150||)||(150||)|
|Net loss applicable to common shareholders||$||(2,759||)||$||(2,996||)||$||(11,118||)||$||(9,102||)|
|Basic and diluted earnings per common share:|
|Net loss per share¿-¿basic and diluted||$||(0.95||)||$||(0.86||)||$||(4.20||)||$||(2.89||)|
|Weighted average common shares outstanding||2,889,893||3,473,696||2,645,159||3,145,730|
|CYCLACEL PHARMACEUTICALS, INC.|
|CONSOLIDATED BALANCE SHEETS|
|(In $000s, except share, per share, and liquidation preference amounts)|
|December 31,||September 30,|
|Cash and cash equivalents||$||20,440||$||18,029|
|Prepaid expenses and other current assets||4,051||4,521|
|Current assets of discontinued operations||75||29|
|Total current assets||24,566||22,579|
|Property, plant and equipment (net)||198||73|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued and other current liabilities||3,738||3,562|
|Current liabilities of discontinued operations||75||29|
|Total current liabilities||5,753||5,570|
|Total stockholders' equity||18,835||16,941|
|Total liabilities and stockholders' equity||$||24,764||$||22,652|
CONTACTSCompany: Paul McBarron, (908) 517-7330, firstname.lastname@example.orgInvestor Relations: Russo Partners LLC, Alexander Fudukidis, (646) 942-5632, email@example.com