On November 12, 2015 Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT) products for the treatment of cancer, reported financial results for the quarter ended September 30, 2015 (Press release, Kite Pharma, NOV 12, 2015, View Source [SID:1234508221]).

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"Over the past few months, we have achieved many significant corporate and clinical development milestones, including the initiation of two pivotal Phase 2 studies of our lead product candidate, KTE-C19," noted Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer. "Our ZUMA-1 trial is enrolling patients with aggressive, refractory non-Hodgkin’s lymphoma, while our ZUMA-2 trial is enrolling patients with relapsed or refractory mantle cell lymphoma. We also plan to initiate two additional pivotal studies of KTE-C19 in patients with acute lymphoblastic leukemia prior to the end of this year. We look forward to reporting data from these trials in 2016 with the goal of filing our first Biologics License Application by the end of 2016."

Recent Highlights

Completed the Phase 1 portion of the KTE-C19 study in aggressive, refractory non-Hodgkin’s lymphoma (NHL) and recently opened enrollment in the pivotal Phase 2 (ZUMA-1) multi-center trial to support registration and potential commercial launch of KTE-C19 in 2017.

Initiated the second pivotal Phase 2 KTE-C19 study (ZUMA-2) in patients with relapsed or refractory mantle cell lymphoma (MCL) to support registration in this indication.

Obtained Orphan Drug Designations in the EU for KTE-C19 in leading hematological malignancies including designation for the treatment of primary mediastinal B-cell lymphoma, MCL, chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, and acute lymphoblastic leukemia (ALL).

Four abstracts were accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, including an abstract on the safety and efficacy data from the Company’s KTE-C19 Phase 1 study in patients with aggressive, refractory NHL.

Expanded our collaboration with the Netherlands Cancer Institute for an exclusive option to license multiple T cell receptor (TCR) gene sequences for the development and commercialization of immunotherapy candidates targeting solid tumors.

Secured an exclusive, worldwide license with the National Institutes of Health to IP related to TCR-based product candidates that target MAGE A3 and A3/A6 antigens.

Secured an exclusive license to Alpine Immune Sciences’ transmembrane immunomodulatory protein (TIP) technology for chimeric antigen receptor and TCR-based products.

Appointed Dr. Franz B. Humer, former Chairman and Chief Executive of Roche Holding Ltd., to our Board of Directors.
Strengthened our Scientific Advisory Board with the addition of Drs. James Allison and Padmanee Sharma, recognized leaders from MD Anderson Cancer Center.

Held the official inauguration for Kite EU, our European headquarters in Amsterdam.
Completed construction of our clinical supply manufacturing facility in Santa Monica.

Third Quarter 2015 Financial Results

Cash Position: As of September 30, 2015, Kite had $368.6 million in cash, cash equivalents, and marketable securities, compared to $367.0 million as of December 31, 2014.

Cash Burn: Cash burn was $24.3 million for the third quarter of 2015, compared to $8.0 million for the third quarter of 2014. This increase was primarily due to the ramp up of our operations supporting the KTE-C19 program, including costs to build out our clinical manufacturing and commercial manufacturing facilities.

Net Loss: GAAP net loss attributable to common stockholders was $27.4 million, or $0.63 per share, for the third quarter of 2015, compared to $9.1 million, or $0.24 per share, for the third quarter of 2014. Non-GAAP net loss attributable to common stockholders for the third quarter of 2015 was $16.6 million, or $0.38 per share. Non-GAAP net loss for the third quarter of 2015 excludes non-cash stock-based compensation expense of $10.8 million for the third quarter of 2015. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net loss to non-GAAP net loss.

Revenue: Revenue was $5.1 million for the third quarter of 2015 compared to $0 for the third quarter of 2014. The increase was primarily due to revenue recognized under the Amgen collaboration.

Total Operating Expenses: Total GAAP operating expenses for the third quarter of 2015 were $32.9 million, compared to $9.1 million for the third quarter of 2014.

R&D Expenses: GAAP research and development (R&D) expenses were $21.7 million for the third quarter of 2015, compared to $5.7 million for the third quarter of 2014, an increase of $16.0 million. This increase was primarily attributable to a $9.1 million increase in research and clinical development expenses supporting the advancement of our KTE-C19 studies and our additional development programs, $3.2 million in expenses related to increased personnel and consulting costs, and $3.7 million of non-cash stock-based compensation expense.

G&A Expenses: GAAP general and administrative (G&A) expenses were $11.1 million for the third quarter of 2015, compared to $3.4 million for the third quarter of 2014, an increase of $7.7 million. This increase was primarily attributable to a $3.0 million increase in personnel related expenses, $0.9 million for license obligations, and $3.8 million of non-cash stock-based compensation.

2015 Financial Guidance: Kite’s guidance remains unchanged. Kite expects to burn between $100 million and $125 million in cash for the full year 2015, which includes both operating expenses and capital expenditures. This guidance does not include cash inflows or outflows for business development activities.

On November 12, 2015 Immune Design (Nasdaq: IMDZ), a clinical-stage immunotherapy company focused on oncology, reported financial results and a corporate update for the third quarter ended September 30, 2015, which includes advancement of its immuno-oncology programs and a cash position of $120.5 million (Press release, Immune Design, NOV 12, 2015, View Source [SID:1234508220]).

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Corporate Update and Recent Highlights

Yesterday, Immune Design announced the dosing of the first patient in the randomized Phase 2 trial of CMB305, the company’s "prime boost" immuno-oncology product candidate, combined with Genentech’s investigational cancer immunotherapy, atezolizumab (MPDL3280A; anti-PD-L1) in patients with soft tissue sarcoma. The trial is being conducted pursuant to a clinical collaboration with Genentech, a member of the Roche Group, which will provide atezolizumab.

On November 5, Immune Design announced that preclinical research on G100, the company’s intratumoral TLR4 agonist-based product candidate, will be presented in an oral presentation at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place December 5-8, 2015 in Orlando, Florida.

On November 3, Immune Design announced new preclinical data showing that each of G100, which contains a potent synthetic TLR4 agonist, and a dendritic-cell targeting hybrid lentiviral vector from its ZVex immunotherapy platform synergize with immune check point inhibitors and demonstrate potent local and systemic anti-tumor activity in cancer models. These data were presented at the 30th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference.

In October, Immune Design highlighted the application of its GLAASTM discovery platform in MedImmune’s Phase 2 clinical trial of MEDI7510. MEDI7510 is an investigational agent for the prevention of respiratory syncytial virus (RSV) under development by MedImmune, the global biologics research and development arm of AstraZeneca.

In August, Immune Design announced the establishment of clinical collaborations with each of Merck and Genentech, a member of the Roche group, covering three clinical trials. In the first collaboration, Merck will contribute KEYTRUDA (pembrolizumab), its anti-PD-1 therapy, to both Immune Design’s planned G100 Phase 1b/2 clinical trial in patients with Non-Hodgkin’s Lymphoma, as well as anLV305 Phase 1 expansion arm in melanoma patients who have an inadequate response to anti-PD1 therapy. Genentech is providing atezolizumab, its investigational anti-PD-L1 therapy, to Immune Design’s randomized Phase 2 trial for patients with selected soft tissue sarcomas expressing NY-ESO-1. Immune Design is the sponsor of these three clinical trials, and none of the parties to these arrangements have transferred any rights to their products to the other.
Financial Results and Guidance

Third Quarter

Immune Design ended the third quarter of 2015 with $120.5 million in cash and cash equivalents, compared to $75.4 million as of December 31, 2014.

Net loss and net loss per share for the third quarter of 2015 were $7.4 million and $0.37, respectively, compared to $6.7 million and $0.55, respectively, for the third quarter of 2014.

Revenue for the third quarter of 2015 was $4.7 million and was attributable primarily to $3.5 million in license revenue associated with Immune Design’s collaborations with MedImmune and Sanofi, $0.8 million in product sales, and $0.3 million in collaboration revenue associated with the Sanofi G103 collaboration established in the fourth quarter of 2014. Revenue for the third quarter of 2014 was $3.5 million and related to license revenue associated with the company’s collaboration with Sanofi.

Research and development expenses for the third quarter of 2015 were $8.3 million, compared to $6.0 million for the third quarter of 2014. The $2.3 million increase was primarily attributable to research and development and contract manufacturing of Immune Design’s G103 HSV-2 investigational agent, which is almost completely paid for under the Sanofi Pasteur G103 collaboration agreement, and for contract manufacturing and clinical trials for LV305 and CMB305. Additionally, there was an increase in personnel-related expenses, including stock-based compensation, as a result of growth in research and development headcount to support the company’s advancing research and clinical pipeline. Research and development stock-based compensation (a non-cash expense), was $0.5 million for the current quarter and $0.2 million for the same quarter in 2014.

General and administrative expenses for the third quarter of 2015 were $3.5 million, compared to $4.1 million for the third quarter of 2014. This decrease was partially offset by increases in facility-related costs and personnel-related expenses, including stock-based compensation, primarily related to an increase in administrative headcount to support the growth and expansion of the business. General and administrative expenses for stock-based compensation (a non-cash expense), was $0.9 million for the current quarter and $0.2 million for the same quarter in 2014.
Year-to-Date

Net operating cash used in operations through September 2015 was $30.3 million, which excludes the $75.4 million in net proceeds received from the company’s follow-on offering in April 2015.

Net loss and net loss per share for the nine months ended September 30, 2015 were $27.3 million and $1.45, respectively, compared to $21.0 million and $4.85, respectively, for the same period in 2014.

Revenue for the nine months ended September 30, 2015 was $8.4 million and was attributable primarily to $3.9 million in collaboration revenue associated with the Sanofi G103 collaboration established in the fourth quarter of 2014, $3.5 million in license revenue associated with the company’s collaborations with MedImmune and Sanofi, and $0.9 million in product sales. Revenue for the same period in 2014 was $4.6 million and was primarily attributable to $4.5 million in license revenue associated with Immune Design’s collaborations with Sanofi and MedImmune.

Total operating expenses for the nine months ended September 30, 2015 were $35.7 million, compared to $21.4 million for the same period in 2014. The increase in the current period relates primarily to an increase in activities to support research and development and contract manufacturing of G103, which is almost completely paid for under the Sanofi Pasteur G103 collaboration, and for contract manufacturing and clinical trials for LV305 and CMB305. Additionally, there was an increase in personnel-related expenses, including stock-based compensation, as a result of growth and expansion of the business following Immune Design’s initial public offering in July 2014, in professional service fees to support operations as a public company and in facility and office costs. These increases were partially offset by a decrease in legal services related to defending ongoing litigation, patents and corporate legal services.

On November 12, 2015 Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, reported its financial results and business highlights for the third quarter ended September 30, 2015 (Press release, Cyclacel, NOV 12, 2015, View Source [SID:1234508218]).

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The Company’s net loss applicable to common shareholders for the third quarter ended September 30, 2015 was $2.8 million, or $0.08 per basic and diluted share, compared to a net loss applicable to common shareholders of $5.0 million, or $0.22 per basic and diluted share for the third quarter ended September 30, 2014. As of September 30, 2015, cash and cash equivalents totaled $22.7 million.

"SEAMLESS continues to progress towards final data read-out," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "There are now approximately 8% of events remaining to occur and we anticipate reporting top-line data during the first half of 2016. Following unblinding and analysis of the data, we will review the results to determine their suitability for submission to regulators. Our CDK2/9 programs made significant progress over the quarter. The CYC065 Phase 1 trial in solid tumor and lymphoma patients has started and the mechanistic rationale for CDK2/9 inhibition in targeted solid tumors and hematological malignancies is supported by multiple presentations at scientific conferences. Seliciclib was administered to the first patients with Cushing’s disease in an investigator-sponsored trial. We and our investigators are excited about the prospects of CDK2/9 inhibitors and we look forward to keeping you apprised as to our progress."

Business Highlights

Sapacitabine in SEAMLESS, pivotal, Phase 3 study for first-line treatment in elderly patients with acute myeloid leukemia (AML):

Continued follow-up with 8% of events remaining before analyzing mature data and reporting top-line results. The SEAMLESS study is powered at 90% to detect a 27.5% improvement of survival between the experimental and control arms.
Cyclin Dependent Kinase (CDK) Inhibitor Programs

Presented the molecular rationale for clinical development of CYC065 for the treatment of solid tumors at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics

Dosed the first patient in a first-in-human, Phase 1 trial of CYC065, the Company’s second-generation CDK2/9 inhibitor, in solid tumor and lymphoma patients to evaluate the safety, tolerability and pharmacokinetic profile of CYC065

Presented the molecular rationale for clinical development of CYC065 for the treatment of leukemias and lymphomas at the Society of Hematologic Oncology (SOHO) 2015 Annual Meeting
Dosed the first patient in a Phase 2 investigator-sponsored trial (IST) evaluating seliciclib as a potential treatment for Cushing’s disease.

CYC065 data to be presented at the upcoming 2015 San Antonio Breast Cancer Symposium in Texas and at the 4th Neuroblastoma Symposium in Newcastle Upon Tyne, United Kingdom
Third Quarter 2015 Financial Results

Revenue

Revenue was $0.7 million for both the three months ended September 30, 2014 and 2015. Revenue is mainly related to grants from the European Union and the Biomedical Catalyst of the United Kingdom government. The Company recognized $0.3 million from its license and supply agreement with ManRos during the three months ended September 30, 2015.

Research and Development Expenses

Research and development expenses were $2.9 million for the three months ended September 30, 2015, compared to $5.0 million for the same period in the previous year. The decrease was primarily a result of reduced expenditures in study and site startup costs associated with the SEAMLESS Phase 3 study this quarter compared to the same period last year.

General and Administrative Expenses

General and administrative expenses for the three months ended September 30, 2015 were $1.2 million compared to $1.4 million for the same period in 2014. The decrease was primarily the result of lower patent-related and stock-based compensation costs.

November 12, 2015 Cellectar Biosciences, Inc. (NASDAQ:CLRB), an oncology-focused biotechnology company, reported financial results for the third quarter of 2015 (Filing, 8-K, Cellectar Biosciences, NOV 12, 2015, View Source [SID:1234508216]).

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During the third quarter of 2015, the company reported a net loss of $1.9 million or ($0.25) per share versus net income of $0.3 million or $0.06 per share for the comparable period in 2014. The shift in profitability was attributable to a large non-cash gain on the revaluation of warrants that are classified as derivative liabilities in 2014. Research and development expenses for the quarter ended September 30, 2015 were $1.2 million, a reduction of $0.3 million from the year prior.

Cellectar’s general and administrative expenses for third quarter 2015 totaled $0.8 million, similar to the prior year period, while restructuring costs in the quarter just ended were $0.1 million. There were no restructuring costs in the third quarter last year.

The Company ended the third quarter with $2.5 million in cash and cash equivalents, compared to $9.4 million in cash and cash equivalents on December 31, 2014. This is exclusive of the $2.9 million, net of expenses, raised in the sale of stock and warrants that closed on October 1, 2015. The Company estimates that its available cash and cash equivalents should fund its planned operations into the second quarter of 2016. Additional capital will be required to complete Cellectar’s planned clinical and preclinical development.

"During the third quarter we implemented a corporate strategic shift for Cellectar Biosciences, repositioning the company around our Phospholipid Drug Conjugate (PDC) Delivery Platform and focusing resources on our therapeutic product portfolio, primarily CLR 131 for relapsed or refractory multiple myeloma and CLR CTX, our research and development program designed to identify new chemotherapeutic product candidates," said Jim Caruso, president and CEO of Cellectar Biosciences. "We believe we have made significant progress toward these goals and look forward to providing additional details during our conference call later today."

Cellectar will be holding a conference call at 5:00 PM ET today to review these results, as well as the company’s development plans. The call can be accessed by calling 888-646-8293. The call will also be webcast and replays will be available, both via the Investor Relations section of the company’s website: investor.cellectarbiosciences.com.

On November 12, 2015 Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) reported business highlights and financial results for the third quarter ended September 30, 2015 (Press release, Celator Pharmaceuticals, NOV 12, 2015, View Source [SID:1234508214]).

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"The momentum builds as we continue to deliver on our milestones, from the induction response rate improvement observed in our Phase 3 study with VYXEOS (formerly CPX-351) and announced last quarter, to impressive results from data packages on novel combination programs," said Scott Jackson, Chief Executive Officer of the Company. "The external validation of our proprietary technologies, as evidenced with VYXEOS being selected as the Nanomedicine Product of the Year is very exciting. We expect the overall survival data from the Phase 3 study in the first quarter of 2016."

Third Quarter 2015 and Recent Highlights:

Celator will receive more than $1.675 million from the sale of its net operating losses and research and development credits under the New Jersey Technology Business Tax Certificate Transfer Program. The Company expects to receive this amount by the end of 2015.

Pre-clinical data presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) demonstrated the broad applicability of Celator’s hydrophobic prodrug nanoparticle (HPN) delivery technology to molecularly targeted agents, including inhibitors of MEK, Akt, HSP90 and B-Raf. Significant efficacy improvements for HPN co-formulated combinations over conventional administration of targeted agent regimens were reported.

VYXEOS (formerly CPX-351) was selected the Best Nanomedicine Product of the Year by a panel of pharmaceutical industry specialists that recognizes innovative product developments in nanomedicine.

Celator announced top-line results from an intensive QT/QTc study showing VYXEOS has no QT/QTc interval prolongation and that additional data will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. This study was conducted to support the New Drug Application for VYXEOS which the Company plans to file in the third quarter of 2016.
The Independent Data and Safety Monitoring Board (DSMB) for the Company’s Phase 3 clinical study with VYXEOS has completed the final pre-planned safety review of all patients and has again recommended the study continue as planned without any modifications.

Patients began enrolling in an investigator-initiated Phase 2 clinical study evaluating VYXEOS as a treatment for patients with newly diagnosed acute myeloid leukemia (AML) at high risk for induction treatment mortality.

Celator’s senior management team hosted an Analyst and Investor Day to discuss the company’s growth strategy, its lead product candidate, VYXEOS, and its proprietary CombiPlex technology platform.

Michael R. Dougherty was appointed Executive Chairman of the Board of Directors. Mr. Dougherty has been a director of Celator since July 2013 and served as Chairman since September 2014.

Financial Highlights:

Cash Position: Cash and cash equivalents as of September 30, 2015 were $24.1 million, compared to $32.4 million as of December 31, 2014. The decrease was primarily due to $13.3 million of net cash used in operating activities, partially offset by $5.0 million in proceeds from the final draw down of the Hercules Technology Growth Capital loan. Cash and cash equivalents as of June 30, 2015 were $28.5 million. Management believes that the cash and cash equivalents at September 30, 2015 will be sufficient to meet estimated working capital requirements and fund planned operations into the second half of 2016.

R&D Expenses: Research and development expenses were $2.9 million and $9.0 million for the three and nine months ended September 30, 2015, as compared to $3.3 million and $9.2 million for the same periods in 2014. The decrease in R&D expenses in the comparable three-month and nine-month periods were primarily due to decreases in regulatory and clinical trial costs related to the Phase 3 study of VYXEOS and manufacturing and drug costs.

G&A Expenses: General and administrative expenses were $1.9 million and $5.7 million for the three and nine months ended September 30, 2015, as compared to $1.9 million and $5.5 million for the same periods of 2014. The increase in the comparable nine-month period was primarily attributable to increases in compensation, public company expenses and professional fees offset by reductions in consulting and recruiting fees.

Net Loss: Net loss was $5.2 million and $14.9 million for the three and nine months ended September 30, 2015, as compared to $5.5 million and $14.5 million for the same periods in 2014.