On August 11, 2015 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the second quarter of 2015 and provided an update on progress toward delivering upon its key 2015 corporate objectives and clinical development milestones (Press release, Exelixis, AUG 11, 2015, View Source;p=RssLanding&cat=news&id=2078887 [SID:1234507207]).

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Key Priorities and Corporate Updates

Exelixis is focused on expediting its regulatory submissions for cabozantinib in advanced renal cell carcinoma (RCC) based on the positive outcome from the METEOR pivotal trial and building its commercial infrastructure to support the launch of cabozantinib in advanced RCC in the United States, pending approval. In addition, Exelixis continues to support its partner Genentech, a member of the Roche Group, as it prepares for the potential worldwide commercialization of cobimetinib, a second Exelixis-discovered compound.

METEOR Trial Delivers Positive Top-Line Results in Advanced RCC. In July 2015, Exelixis announced that METEOR met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) for cabozantinib versus everolimus in a population of patients with advanced renal cell carcinoma who have experienced disease progression following treatment with at least one prior VEGFR tyrosine kinase inhibitor. The primary analysis was conducted on the first 375 patients enrolled, and the hazard ratio (HR) was 0.58 (95% CI 0.45-0.75, p<0.0001), equating to a 42% decrease in the risk of disease progression or death for the cabozantinib arm. As expected, data pertaining to overall survival (OS) for the entire 658-patient study population were not mature at the data cut-off, but a pre-planned interim analysis showed a trend favoring cabozantinib (HR=0.67, unadjusted 95 percent CI 0.51-0.89; p=0.005). At the time of the interim analysis, the pre-specified p-value of 0.0019 to achieve statistical significance was not reached. The trial will continue to the final OS analysis anticipated in 2016. The frequency of serious adverse events of any grade, regardless of causality, was approximately balanced between study arms, and the rate of discontinuations for adverse events was low (10%) in both arms.

U.S. and EU Regulatory Filings for Cabozantinib in Advanced RCC Planned for Early 2016. Having obtained positive top-line results for METEOR, Exelixis’ highest corporate priority is the completion of regulatory filings for cabozantinib in advanced RCC. Based on the data from the trial, the company intends to complete regulatory filings in the U.S. and European Union in early 2016. Earlier this year, cabozantinib received Fast Track designation by the U.S. Food and Drug Administration.

Recently Initiated Trial Combines Cabozantinib with Immunotherapies. In July 2015, Exelixis’ collaborators at the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP) initiated a phase 1 trial of cabozantinib in combination with nivolumab alone, or in combination with nivolumab plus ipilimumab, in patients with genitourinary tumors, including bladder cancer and RCC. The primary endpoint of the trial is the determination of dose-limiting toxicities, and a recommended phase 2 dose, for the combinations. Exelixis believes that there is a strong rationale for combining cabozantinib with immunotherapies, including clinical evidence of cabozantinib’s ability to create a more immune-permissive environment, as well as preclinical data suggesting cabozantinib increases T-cell infiltration into tumors. Data from this trial could have relevance in other disease settings, including non-small cell lung cancer (NSCLC).

Data at ASCO (Free ASCO Whitepaper) Underscore Potential of Cabozantinib in NSCLC. Oral presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s 2015 Annual Meeting, May 29 – June 2, highlighted positive data from two trials of cabozantinib in molecularly-defined subtypes of NSCLC. An investigator-sponsored phase 2 trial of cabozantinib in RET-rearranged NSCLC met its primary endpoint, exceeding the predefined number of objective responses. A second trial, conducted by the ECOG-ACRIN Cancer Research Group under Exelixis’ cooperative research and development agreement with NCI-CTEP, also met its primary endpoint, extending PFS for cabozantinib and the combination of cabozantinib and erlotinib versus erlotinib alone in EGFR wild-type NSCLC. Exelixis is committed to working with its collaborators at the NCI and at ECOG-ACRIN to explore further development of cabozantinib in lung cancer.

Cobimetinib Commercialization Planning Continues Ahead of Anticipated Regulatory Decisions. Also at ASCO (Free ASCO Whitepaper), investigators presented updated data from coBRIM, the phase 3 pivotal trial of cobimetinib in combination with vemurafenib in patients with advanced melanoma harboring a BRAF V600 mutation. coBRIM formed the basis for Genentech’s and Roche’s regulatory filings in the U.S. and EU, respectively, for which both companies anticipate decisions later this year. In the U.S., Genentech’s New Drug Application received priority review, and the Prescription Drug User Fee Act action date is now November 11, 2015. Cobimetinib, a selective MEK inhibitor discovered by Exelixis, is the subject of a worldwide collaboration agreement between Exelixis and Genentech. Pursuant to this agreement, Exelixis is entitled to an initial equal share of U.S. profits and losses, with Exelixis’ share decreasing as sales increase. The parties will share equally in the U.S. marketing and commercialization costs, and, if approved, Exelixis will co-promote the compound in the U.S. Outside the U.S., Exelixis is entitled to receive royalties on sales of cobimetinib.

Christopher J. Senner Joins Exelixis as EVP and Chief Financial Officer. In July 2015, Exelixis appointed Chris Senner to the role of Executive Vice President and Chief Financial Officer. Mr. Senner has nearly 25 years of experience in biopharmaceutical finance. He joined Exelixis following five years at Gilead Sciences, where he most recently served as Vice President, Corporate Finance. Prior to joining Gilead, Mr. Senner spent eighteen years at Wyeth in a variety of financial roles with increasing responsibility for many of the company’s divisions and regions.

Extension of Maturity Date of Indebtedness Under the Note Purchase Agreement with Deerfield. On July 1, 2015, Exelixis extended the maturity date of the Deerfield Notes from July 1, 2015 to July 1, 2018. The Deerfield Notes will bear interest on and after July 2, 2015, at the rate of 7.5% per annum to be paid in cash, quarterly in arrears, and 7.5% per annum to be paid in kind, quarterly in arrears, for a total interest rate of 15% per annum and will mature on July 1, 2018.

Public Offering of Stock Raises Net Proceeds of $146 Million. After the second quarter ended, Exelixis launched and completed a public offering of common stock. The company issued 28,750,000 shares, including 3,750,000 shares issued under the underwriters’ 30-day option to buy shares, at a price to the public of $5.40 per share, receiving approximately $146 million in net proceeds after deducting the underwriting discount and other estimated offering expenses payable by Exelixis. Exelixis currently expects to use the net proceeds from the offering for general corporate purposes, including for clinical trials, build-out of commercial infrastructure, research and development, capital expenditures and working capital.

"The second quarter, and the weeks following it, are some of the most significant in Exelixis history," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of the company. "As announced in July, cabozantinib delivered impressive results in the METEOR trial, including a statistically significant and clinically meaningful improvement in PFS, along with a strong trend toward improving overall survival, as compared to everolimus, a widely-used agent in the second and later lines of advanced RCC treatment. The data will serve as the foundation for regulatory filings in the U.S. and EU, which we intend to complete in early 2016."

Dr. Morrissey continued: "As we move into the third quarter with METEOR data in hand, all of us at Exelixis share an even greater sense of urgency and focus around maximizing the potential of our pipeline to help patients with cancer. This is illustrated by our recent activities, including the recruitment of a new chief financial officer with global commercial finance expertise, advancement of our discussions around a potential partnership for ex-U.S. rights to cabozantinib, and the initiation of a new trial evaluating cabozantinib in combination with immunotherapies. At the same time, alongside our partners Roche and Genentech, we have completed our commercial readiness for the potential U.S. regulatory approval of cobimetinib later this year."

COMETRIQ Product Revenue. Net product revenue from COMETRIQ (cabozantinib capsules) sales was $8.0 million for the second quarter of 2015.

2015 Financial Guidance. The company anticipates that operating expenses for the second six months of 2015 will be in a range of $80 million to $90 million, including approximately $10 million of incremental non-cash stock-based compensation expense related to the vesting of performance stock options tied to the read-out of METEOR top-line results.

Second Quarter 2015 Financial Results

Net revenues for the quarter ended June 30, 2015 were $8.0 million, compared to $6.6 million for the comparable period in 2014. Net revenues consisted entirely of product revenue related to the sale of COMETRIQ.

Research and development expenses for the quarter ended June 30, 2015 were $24.5 million, compared to $51.0 million for the comparable period in 2014. The decrease was primarily related to a net decrease in clinical trial costs, predominantly due to decreases in costs related to COMET-1 and COMET-2, the company’s phase 3 trials in metastatic castration-resistant prostate cancer, and decreases in personnel related expenses resulting from an overall reduction in headcount.

Selling, general and administrative expenses for the quarter ended June 30, 2015 were $12.8 million, compared to $16.5 million for the comparable period in 2014. The decrease was primarily related to a decrease in personnel and stock-based compensation expenses resulting from an overall reduction in headcount, consulting and outside services, and legal and patent costs. Those decreases were partially offset by higher marketing expenses, including expenses for cobimetinib under the company’s collaboration agreement with Genentech.

Restructuring charge for the quarter ended June 30, 2015 was $1.3 million. The restructuring charge was primarily related to the exit of certain facilities, the partial termination of one of Exelixis’ building leases and subleasing activities during the period.

Other income (expense), net for the quarter ended June 30, 2015 was a net expense of ($12.1) million compared to ($11.7) million for the comparable period in 2014. The net expense is comprised primarily of interest expense which includes $7.2 million of non-cash expense related to the accretion of the discounts on both the 4.25% Convertible Senior Subordinated Notes due 2019 and the company’s indebtedness under the Deerfield Notes for the quarter ended June 30, 2015, as compared to $7.3 million for the comparable period in 2014.

Net loss for the quarter ended June 30, 2015 was ($43.4) million, or ($0.22) per share, basic, compared to ($73.4) million, or ($0.38) per share, basic, for the comparable period in 2014. The decreased net loss for the quarter was primarily due to decreases in research and development expenses and selling, general and administrative expenses and an increase in product revenues.

Cash and cash equivalents, short- and long-term investments and short- and long-term restricted cash and investments totaled $167.0 million at June 30, 2015 compared to $242.8 million at December 31, 2014. The June 30, 2015 cash position was prior to the launch of the company’s public offering of stock on July 21, 2015, as noted above.

On August 11, 2015 Sorrento Therapeutics, Inc. (NASDAQ: SRNE; Sorrento) reported that it as well as its wholly-owned subsidiary TNK Therapeutics, Inc. have entered into a binding term sheet to exclusively license the NanoVelcro Circulating Tumor Cell (CTC) profiling assay technology from CytoLumina Technologies Corp. and FetoLumina Technologies Corp., two privately-held sister biotechnology companies in Los Angeles, California (Filing, 8-K, Sorrento Therapeutics, AUG 11, 2015, View Source [SID:1234507204]). The exclusive licenses will cover the applications of the NanoVelcro CTC assay and its portfolio technologies for precision medicine diagnostics in conjunction with all cellular therapies and Sorrento antibody therapeutics.

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The NanoVelcro Chip is a device capable of enriching, isolating, and identifying CTCs from peripheral blood of cancer patients. Coupled with downstream molecular assays, it enables the characterization of individually isolated CTCs, thus providing diagnostic information for the monitoring of real-time disease progression and tailoring individualized therapy solutions for cancer patients. The NanoVelcro Chip utilizes antibody-coated nanostructured substrates to capture CTCs with high efficiency. Once the CTCs are immobilized on the NanoVelcro Chips, laser capture microdissection technology allows for selective recovery of the CTCs with single-cell precision, virtually eliminating any trace of contamination from white blood cells that might complicate further downstream analysis. Finally, the isolated and purified CTCs are subjected to in-depth molecular characterization, including mutational analysis, copy number variance, expression profiling, multi-color protein staining as well as quantification of key phospho-proteins in signal transduction networks. These CTC-derived molecular signatures may help doctors to implement personalized therapies targeting a patient’s unique cancer.

"We are excited to work with Sorrento and TNK Therapeutics, as we believe our technology may harness CTC’s potential as "liquid biopsy" to overcome the challenges encountered in the conventional tumor biopsy and significantly advance the field of precision medicine. Our device has been tested with peripheral blood samples from more than 1000 cancer patients suffering from a variety of solid tumors, including breast, prostate, pancreatic, gastro-intestinal, kidney, hepatocellular, non-small cell lung cancer, and melanoma", said Hsian-Rong Tseng, PhD, Professor of Molecular and Medical Pharmacology at University of California at Los Angeles (UCLA), faculty at the California NanoSystems Institute, Member of the Jonsson Comprehensive Cancer Center, and the inventor of the NanoVelcro Chip.

"Working with CytoLumina and FetoLumina and utilizing the NanoVelcro Chip technology as companion diagnostics will put Sorrento and TNK Therapeutics into a unique position in the antibody and adoptive cellular immunotherapy field", said Dr. Henry Ji, President and CEO of Sorrento. "One of the biggest challenges in cancer therapy is that every patient’s tumor is heterogeneous and often mutates and evolves over the course of treatment. The NanoVelcro CTC assay will enable the precise identification of tumor surface antigens on individual patient’s cancer cells in a minimally invasive manner. For CTC capture on the NanoVelcro chip, we will use matching Sorrento antibodies that TNK Therapeutics will incorporate into its chimeric antigen receptors (CAR) for CAR-T or CAR.TNK therapies, thus paving the way for implementation of personalized immunotherapies."

On August 11, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN) reported financial results for its fiscal fourth-quarter and fiscal full year ended June 30, 2015, provided an update on recent business highlights and provided fiscal year 2016 and fiscal first-quarter 2016 financial guidance (Press release, Myriad Genetics, AUG 11, 2015, View Source [SID:1234507203]).

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"We delivered sequential growth in the fourth quarter and made significant progress towards completing the conversion of our targeted physician base to myRisk Hereditary Cancer testing," said Mark C. Capone, president and chief executive officer of Myriad. "As we look forward to fiscal year 2016, we are confident that we are poised to generate top- and bottom-line growth beginning a trend that reflects increased investments in our product pipeline and international expansion. Over the next several years, we expect that these investments will drive revenue growth and operating leverage as we look to transform Myriad into a worldwide personalized medicine company."

Financial Highlights

myRisk Hereditary Cancer testing revenue increased to $100.9 million in the fourth quarter of fiscal 2015 from $27.3 million in the fourth quarter of the prior year, and the Company exited the quarter with 72 percent of incoming hereditary cancer samples ordered as myRisk.

The decline in both adjusted operating and net income in the fiscal fourth quarter 2015 relative to the prior year is attributable to lower gross margins associated with the transition costs of myRisk Hereditary Cancer testing and incremental product launch expenses for Prolaris, myPath Melanoma and myPlan Lung Cancer tests.

During the quarter, the Company repurchased approximately 1.3 million shares, or $45 million, of common stock under its share repurchase program and ended the quarter with approximately $155 million remaining on its current share repurchase authorization. Fiscal fourth-quarter diluted weighted average shares outstanding were 72.4 million compared to 77.7 million in the same period last year.

Business Highlights

Myriad presented data on 19 abstracts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) including:
Results from the Geparsixto study that showed the ability of the myChoice HRD test to predict response to carboplatin containing chemotherapy in 193 patients with triple negative breast cancer. The highest response rate of 64 percent was seen in patients with a positive HRD score who received both carboplatin and standard of care chemotherapy, compared to 30 percent in patients with a negative HRD score.

Data demonstrating the ability of myChoice HRD to identify responders to Tesaro’s novel therapeutic drug candidate niraparib. In a study of 106 patients with advanced ovarian cancer, myChoice HRD identified 100 percent of responders to the investigational drug.

A study of almost 77,000 patients tested with myRisk Hereditary Cancer demonstrated that the detection rate for mutations increased 130 percent relative to BRCA1/BRCA2 testing alone. We also presented a study on endometrial cancer demonstrating that over 9 percent of patients carried a deleterious mutation in one of the myRisk genes, which we believe justifies broad testing for this population consistent with recent National Comprehensive Cancer Network (NCCN) recommendations.
Vectra DA volumes increased to a new record in the fiscal fourth quarter, growing 12 percent sequentially to just under 40,000 tests ordered with revenue up 12 percent sequentially to $11.8 million.

Presented data at the America Urological Association (AUA) meeting including:
Key data defining an active surveillance threshold for our Prolaris test. The active surveillance threshold sets a defined cutoff for patients and has been clinically validated to show patients with scores below the cutoff have a 10-year prostate cancer specific mortality of less than 3 percent.

The final results of the PROCEDE 1,000 clinical utility study that evaluated the impact of the Prolaris score on treatment recommendations for 1,206 prostate cancer patients. The final data showed that physicians had a 48 percent change in treatment recommendations in which 35 percent of patients saw a reduction in therapy and 13 percent saw an increase in therapy.

Fiscal First-Quarter and Fiscal Full Year 2016 Financial Guidance

These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further details on its business outlook during the conference call it is holding today to discuss its fiscal fourth quarter and full year 2015 financial results and fiscal year 2016 financial guidance.

On August 11, 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 second quarter ended June 30, 2015 (Press release, Cyclacel, AUG 11, 2015, View Source [SID:1234507201]).

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The Company’s net loss applicable to common shareholders for the second quarter ended June 30, 2015 was $3.4 million, or $0.10 per basic and diluted share, compared to a net loss income applicable to common shareholders of $4.9 million, or $0.22 per basic and diluted share for the second quarter ended June 30, 2014. As of June 30, 2015, cash and cash equivalents totaled $26.9 million.

"SEAMLESS continues to progress towards final data read-out," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "There are now approximately 13% of events remaining to occur and we expect to report top-line data during the second half of 2015 through the first half of 2016. Following unblinding and analysis of the SEAMLESS data, we will determine their suitability for submission to regulators in the U.S. and Europe. Additionally, in the Phase 1 study of our all-oral combination of sapacitabine with our first-generation CDK2/9 inhibitor, seliciclib, we reported updated data in heavily pretreated cancer patients with BRCA mutations. The data showed a 55% overall response rate with patients achieving durable benefit after multiple cycles of therapy, including a breast cancer patient who has received to date over 60 cycles. These promising data are encouraging us to explore this regimen further. Our next generation CDK2/9 inhibitor, CYC065, received institutional review board approval for a first-in-human, Phase 1 study in advanced solid tumors and we expect to start treating patients shortly. CYC065 has demonstrated increased potency compared to seliciclib. Based on published preclinical efficacy data, we plan to develop CYC065 as a targeted anticancer agent in both hematological and solid cancers. In addition to our focus on SEAMLESS, we have continued to make progress with our other programs, while ensuring we have sufficient resources to deliver on our key milestones and execute on our business strategy."

Business Highlights

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

Continued to follow-up patients as 13% of events remain to occur before analyzing the 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.
Sapacitabine and seliciclib, all-oral combination in Phase 1 study in patients with advanced solid tumors

Observed an overall response rate of 55% in breast, ovarian and pancreatic patients with BRCA mutations in updated data from this study of heavily pre-treated patients.

Cyclin Dependent Kinase (CDK) Inhibitor Programs

Received institutional review board approval to start a first-in-human Phase 1 trial of CYC065, the Company’s second generation CDK2/9 inhibitor, in solid tumor patients to evaluate the safety, tolerability and pharmacokinetic profile of CYC065.
Presented preclinical data demonstrating therapeutic potential of CYC065 as a targeted anticancer agent at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2015. The data show that CYC065 may reverse drug resistance associated with addiction of cancer cells to cyclin E, the partner protein of CDK2. CYC065 may also inhibit CDK9-dependent oncogenic and leukemogenic pathways, including malignancies driven by certain oncogene and MLL rearrangements. MLL gene status and levels of Bcl-2 family proteins correlated with sensitivity of AML cell lines to CYC065. CYC065’s anticancer activity presents an opportunity for patient stratification and combinations with anti-leukemic agents. CYC065 was also effective against uterine cancer cells including those resistant to chemotherapy and was especially potent in uterine cancer cells in which cyclin E was amplified or overexpressed.
Entered into a license and supply agreement with ManRos Therapeutics regarding the development of seliciclib, the Company’s first generation CDK inhibitor, in cystic fibrosis.

Dosed first patient in Phase 2 investigator sponsored trial (IST) evaluating seliciclib as a potential treatment for Cushing’s disease.

Other Events

Entered into a Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald & Co., as sales agent ("Cantor"), under which the Company may, from time to time, sell shares of its common stock having an aggregate offering price of up to $8.35 million through Cantor.

Transferred the listing of the Company’s common stock from the NASDAQ Global Market to the NASDAQ Capital Market effective at the opening of business on August 6, 2015. The Company’s common stock will continue to trade under the symbol "CYCC." The Company currently meets the NASDAQ Capital Market initial listing criteria, except for the bid price requirement. With the transfer to the NASDAQ Capital Market, the Company is being afforded an additional 180-day grace period to regain compliance with NASDAQ’s minimum bid price requirement of a stock price of at least $1.00 for at least ten consecutive business days during this grace period ending on February 2, 2016 or be delisted.

Second Quarter 2015 Financial Results

Grant Revenue

Revenue for the three months ended June 30, 2015, was $0.3 million compared to $0.4 million for the same period of the previous year. The revenue is related to grants from the European Union and the Biomedical Catalyst of the United Kingdom government.

Research and Development Expenses

Research and development expenses were $2.6 million for the three months ended June 30, 2015, compared to $4.5 million for the same period in the previous year. The decrease was primarily a result of reduced expenditure in 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 June 30, 2015 remained relatively flat at $1.3 million compared to $1.4 million for the same period in 2014.

On August 11, 2015 Celator Pharmaceuticals, Inc. (Nasdaq: CPXX), a biopharmaceutical company that is transforming the science of combination therapy and developing products to improve patient outcomes in cancer, reported business highlights and financial results for the second quarter ended June 30, 2015 (Press release, Celator Pharmaceuticals, AUG 11, 2015, View Source [SID:1234507200]).

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"We capped off a very busy second quarter by reporting positive induction response rate data in the Phase 3 study of VYXEOS (CPX-351) in patients with high-risk (e.g. secondary) acute myeloid leukemia (AML)," said Scott Jackson, chief executive officer of the Company. "We believe response is an important surrogate for overall survival and clinical benefit in this patient population. We intend to build on that momentum as we advance our broader clinical development program, report data on CombiPlex technology platform studies, and increase pre-commercial activities." Mr. Jackson continued, "Data on overall survival are expected in the first quarter of 2016, with an NDA submission planned for the third quarter of 2016. If approved, VYXEOS will be well-positioned to become the foundation of care for high-risk AML patients."

Second Quarter 2015 and Recent Highlights:

The Company reported positive induction response rate results from the Phase 3 study of CPX-351 in patients with high-risk (e.g. secondary) AML.

The FDA granted approval of the brand name VYXEOS for CPX-351.

Enrollment was completed in a Phase 2 pharmacokinetic and pharmacodynamics (PK/PD) study evaluating the effects of CPX-351 on cardiac repolarization in adult patients with acute hematologic malignancies, including AML, acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS).

As part of the Company’s existing $5 million Phase 3 partnership with the Leukemia & Lymphoma Society, Celator achieved a milestone payment of $900,000 based on positive induction response rate data from the Phase 3 study, thereby bringing the total amount received to date to $4.9 million.

At the Company’s Analyst and Investor Day, management presented an overview of the company’s growth strategy which included VYXEOS and our proprietary technology platform, CombiPlex. Key thought leaders, Gail Roboz, M.D. and Bruno C. Medeiros, M.D., discussed AML and VYXEOS. In addition, Anthony Tolcher, M.D., presented on the challenges and opportunities of combining molecularly targeted agents which may be addressed by CombiPlex. The presentations are on the Company’s website at: View Source!events-and-presentations/c1iw5

The Company announced that enrollment had commenced in an investigator-initiated Phase 2 clinical study, at MD Anderson Cancer Center, evaluating CPX-351 as a treatment for patients with newly diagnosed AML at high risk for induction treatment mortality.

Based on encouraging safety and efficacy results, a patient cohort was expanded in an investigator-initiated study, being conducted at both the Fred Hutchinson Cancer Research Center and Stanford University, evaluating CPX-351 in patients with either untreated MDS or AML at high-risk of treatment-related mortality.

Data were presented describing the effects of combining CPX-351 with traditional chemotherapy and novel molecularly targeted agents intended for use in treating AML and other blood cancers at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

Financial Highlights:

Cash Position: Cash and cash equivalents as of June 30, 2015 were $28.5 million, compared to $32.4 million as of December 31, 2014. The decrease of $3.9 million was primarily due to $9.0 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 March 31, 2015 were $32.9 million. Management believes that the cash and cash equivalents at June 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 $3.5 million and $6.2 million for the three and six months ended June 30, 2015, as compared to $2.9 million and $5.9 million for the same periods in 2014. The increase in R&D expenses in the comparable three-month periods was primarily due to increases in outsourced clinical trial and regulatory activities related to CPX-351 and additional manufacturing costs. The increase between the comparable six-month periods was primarily due to increases in outsourced clinical trial and regulatory activities related to CPX-351 and were partially offset by reduced manufacturing and research costs.

G&A Expenses: General and administrative expenses were $2.0 million and $3.8 million for the three and six months ended June 30, 2015, as compared to $1.7 million and $3.6 million for the same periods of 2014. The increases were primarily attributable to increases in investor relations, professional fees and public company-related costs. These increases were offset by decreases in consulting costs associated with commercial development.

Net Loss: Net loss was $5.0 and $9.7 million for the three and six months ended June 30, 2015, as compared to $4.8 million and $9.1 million for the same periods in 2014.